# Official Journal C 14/16 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 14 |
| | |
| English edition | Information and Notices | Volume 5816 January 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 14

English edition

Information and Notices

Volume 5816 January 2015

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 014/01 | Commission communication in the framework of the implementation of Directive 2004/108/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  ) | 1 |
| 2015/C 014/02 | Commission communication in the framework of the implementation of the Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  ) | 22 |
| 2015/C 014/03 | Commission communication in the framework of the implementation of the Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Publication of titles and references of European standards under the directive)
   (
  1
  ) | 29 |
| 2015/C 014/04 | Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  ) | 36 |
| 2015/C 014/05 | Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  ) | 43 |
| 2015/C 014/06 | Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  ) | 74 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 014/01

Commission communication in the framework of the implementation of Directive 2004/108/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  )

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

1

1

2015/C 014/02

Commission communication in the framework of the implementation of the Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  )

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

1

22

2015/C 014/03

Commission communication in the framework of the implementation of the Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Publication of titles and references of European standards under the directive)
   (
  1
  )

(Publication of titles and references of European standards under the directive)

1

29

2015/C 014/04

Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  )

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

1

36

2015/C 014/05

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  )

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

1

43

2015/C 014/06

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)
   (
  1
  )

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

1

74

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| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 16.1.2015 | EN | Official Journal of the European Union | C 14/1 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/1

---

Commission communication in the framework of the implementation of Directive 2004/108/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 014/01)

| ESO (1) | Reference and title of the standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- |
| (1) | (2) | (3) | (4) |
| CEN | EN 617:2001+A1:2010
  Continuous handling equipment and systems — Safety and EMC requirements for the equipment for the storage of bulk materials in silos, bunkers, bins and hoppers | EN 617:2001
  Note 2.1 | Date expired
  (30.6.2011) |
| CEN | EN 618:2002+A1:2010
  Continuous handling equipment and systems — Safety and EMC requirements for equipment for mechanical handling of bulk materials except fixed belt conveyors | EN 618:2002
  Note 2.1 | Date expired
  (30.6.2011) |
| CEN | EN 619:2002+A1:2010
  Continuous handling equipment and systems — Safety and EMC requirements for equipment for mechanical handling of unit loads | EN 619:2002
  Note 2.1 | Date expired
  (30.4.2011) |
| CEN | EN 620:2002+A1:2010
  Continuous handling equipment and systems — Safety and EMC requirements for fixed belt conveyors for bulk materials | EN 620:2002
  Note 2.1 | Date expired
  (30.6.2011) |
| CEN | EN 1155:1997
  Building hardware — Electrically powered hold-open devices for swing doors — Requirements and test methods | | |
| CEN | EN 12015:2014
  Electromagnetic compatibility — Standard family product for lifts, escalators and moving walks — Emission | EN 12015:2004
  Note 2.1 | Date expired
  (30.9.2014) |
| CEN | EN 12016:2013
  Electromagnetic compatibility — Product family standard for lifts, escalators and moving walks — Immunity | EN 12016:2004+A1:2008
  Note 2.1 | Date expired
  (28.2.2014) |
| CEN | EN 12895:2000
  Industrial trucks — Electromagnetic compatibility | | |
| CEN | EN 13241-1:2003+A1:2011
  Industrial, commercial and garage doors and gates — Product standard — Part 1: Products without fire resistance or smoke control characteristics | EN 13241-1:2003
  Note 2.1 | Date expired
  (31.10.2011) |
| CEN | EN 13309:2010
  Construction machinery — Electromagnetic compatibility of machines with internal power supply | EN 13309:2000
  Note 2.1 | Date expired
  (31.1.2011) |
| CEN | EN 14010:2003+A1:2009
  Safety of machinery — Equipment for power driven parking of motor vehicles — Safety and EMC requirements for design, manufacturing, erection and commissioning stages | EN 14010:2003
  Note 2.1 | Date expired
  (31.1.2010) |
| CEN | EN ISO 14982:2009
  Agricultural and forestry machinery — Electromagnetic compatibility — Test methods and acceptance criteria (ISO 14982:1998) | EN ISO 14982:1998
  Note 2.1 | Date expired
  (28.12.2009) |
| CEN | EN 16361:2013
  Power operated pedestrian doors — Product standard, performance characteristics — Pedestrian doorsets, other than swing type, initially designed for installation with power operation without resistance to fire and smoke leakage characteristics | | |
| Cenelec | EN 50065-1:2011
  Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 1: General requirements, frequency bands and electromagnetic disturbances | EN 50065-1:2001
  - A1:2010
  Note 2.1 | Date expired
  (21.3.2014) |
| Cenelec | EN 50065-2-1:2003
  Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-1: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 95 kHz to 148,5 kHz and intended for use in residential, commercial and light industrial environments | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.10.2004) |
| | EN 50065-2-1:2003/AC:2003 | | |
| | EN 50065-2-1:2003/A1:2005 | Note 3 | Date expired
  (1.7.2008) |
| Cenelec | EN 50065-2-2:2003
  Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-2: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 95 kHz to 148,5 kHz and intended for use in industrial environments | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.10.2004) |
| | EN 50065-2-2:2003/AC:2003 | | |
| | EN 50065-2-2:2003/A1:2005/AC:2006 | | |
| | EN 50065-2-2:2003/A1:2005 | Note 3 | Date expired
  (1.7.2008) |
| Cenelec | EN 50065-2-3:2003
  Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-3: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 3 kHz to 95 kHz and intended for use by electricity suppliers and distributors | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.8.2004) |
| | EN 50065-2-3:2003/AC:2003 | | |
| | EN 50065-2-3:2003/A1:2005 | Note 3 | Date expired
  (1.7.2008) |
| Cenelec | EN 50083-2:2012
  Cable networks for television signals, sound signals and interactive services — Part 2: Electromagnetic compatibility for equipment | EN 50083-2:2006
  Note 2.1 | Date expired
  (21.6.2013) |
| Cenelec | EN 50121-1:2006
  Railway applications — Electromagnetic compatibility — Part 1: General | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.7.2009) |
| | EN 50121-1:2006/AC:2008 | | |
| Cenelec | EN 50121-2:2006
  Railway applications — Electromagnetic compatibility — Part 2: Emission of the whole railway system to the outside world | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2009) |
| | EN 50121-2:2006/AC:2008 | | |
| Cenelec | EN 50121-3-1:2006
  Railway applications — Electromagnetic compatibility — Part 3-1: Rolling stock — Train and complete vehicle | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2009) |
| | EN 50121-3-1:2006/AC:2008 | | |
| Cenelec | EN 50121-3-2:2006
  Railway applications — Electromagnetic compatibility — Part 3-2: Rolling stock — Apparatus | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2009) |
| | EN 50121-3-2:2006/AC:2008 | | |
| Cenelec | EN 50121-4:2006
  Railway applications — Electromagnetic compatibility — Part 4: Emission and immunity of the signalling and telecommunications apparatus | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2009) |
| | EN 50121-4:2006/AC:2008 | | |
| Cenelec | EN 50121-5:2006
  Railway applications — Electromagnetic compatibility — Part 5: Emission and immunity of fixed power supply installations and apparatus | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2009) |
| | EN 50121-5:2006/AC:2008 | | |
| Cenelec | EN 50130-4:2011
  Alarm systems — Part 4: Electromagnetic compatibility — Product family standard: Immunity requirements for components of fire, intruder, hold up, CCTV, access control and social alarm systems | EN 50130-4:1995
  and its amendments
  Note 2.2 | Date expired
  (13.6.2014) |
| Cenelec | EN 50148:1995
  Electronic taximeters | Relevant generic standard(s)
  Note 2.3 | Date expired
  (15.12.1995) |
| Cenelec | EN 50270:2006
  Electromagnetic compatibility — Electrical apparatus for the detection and measurement of combustible gases, toxic gases or oxygen | EN 50270:1999
  Note 2.3 | Date expired
  (1.6.2009) |
| Cenelec | EN 50293:2000
  Electromagnetic compatibility — Road traffic signal systems — Product standard | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.4.2003) |
| Cenelec | EN 50293:2012
  Road traffic signal systems — Electromagnetic compatibility | EN 50293:2000
  Note 2.1 | Date expired
  (11.5.2015) |
| Cenelec | EN 50295:1999
  Low-voltage switchgear and controlgear — Controller and device interface systems — Actuator Sensor interface (AS-i) | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.12.1999) |
| Cenelec | EN 50370-1:2005
  Electromagnetic compatibility (EMC) — Product family standard for machine tools — Part 1: Emission | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.2.2008) |
| Cenelec | EN 50370-2:2003
  Electromagnetic compatibility (EMC) — Product family standard for machine tools — Part 2: Immunity | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.11.2005) |
| Cenelec | EN 50412-2-1:2005
  Power line communication apparatus and systems used in low-voltage installations in the frequency range 1,6 MHz to 30 MHz — Part 2-1: Residential, commercial and industrial environment — Immunity requirements | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.4.2008) |
| | EN 50412-2-1:2005/AC:2009 | | |
| Cenelec | EN 50428:2005
  Switches for household and similar fixed electrical installations — Collateral standard — Switches and related accessories for use in home and building electronic systems (HBES) | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.1.2008) |
| | EN 50428:2005/A2:2009 | Note 3 | Date expired
  (1.6.2012) |
| | EN 50428:2005/A1:2007 | Note 3 | Date expired
  (1.10.2010) |
| Cenelec | EN 50470-1:2006
  Electricity metering equipment (a.c.) — Part 1: General requirements, tests and test conditions — Metering equipment (class indexes A, B and C)
  IEC 62052-11:2003 | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.5.2009) |
| Cenelec | EN 50490:2008
  Electrical installations for lighting and beaconing of aerodromes — Technical requirements for aeronautical ground lighting control and monitoring systems — Units for selective switching and monitoring of individual lamps | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.4.2011) |
| Cenelec | EN 50491-5-1:2010
  General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-1: EMC requirements, conditions and test set-up | EN 50090-2-2:1996
  - A2:2007
  Note 2.1 | Date expired
  (1.4.2013) |
| Cenelec | EN 50491-5-2:2010
  General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-2: EMC requirements for HBES/BACS used in residential, commercial and light industry environment | EN 50090-2-2:1996
  - A2:2007
  Note 2.1 | Date expired
  (1.4.2013) |
| Cenelec | EN 50491-5-3:2010
  General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-3: EMC requirements for HBES/BACS used in industry environment | EN 50090-2-2:1996
  - A2:2007
  Note 2.1 | Date expired
  (1.4.2013) |
| Cenelec | EN 50498:2010
  Electromagnetic compatibility (EMC) — Product family standard for aftermarket electronic equipment in vehicles | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.7.2013) |
| Cenelec | EN 50512:2009
  Electrical installations for lighting and beaconing of aerodromes — Advanced Visual Docking Guidance Systems (A-VDGS) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.12.2011) |
| Cenelec | EN 50529-1:2010
  EMC Network Standard — Part 1: Wire-line telecommunications networks using telephone wires | | |
| Cenelec | EN 50529-2:2010
  EMC Network Standard — Part 2: Wire-line telecommunications networks using coaxial cables | | |
| Cenelec | EN 50550:2011
  Power frequency overvoltage protective device for household and similar applications (POP) | | |
| | EN 50550:2011/A1:2014 | Note 3 | Date expired
  (28.7.2017) |
| | EN 50550:2011/AC:2012 | | |
| Cenelec | EN 50557:2011
  Requirements for automatic reclosing devices (ARDs) for circuit breakers-RCBOs-RCCBs for household and similar uses | | |
| Cenelec | EN 50561-1:2013
  Power line communication apparatus used in low-voltage installations — Radio disturbance characteristics — Limits and methods of measurement — Part 1: Apparatus for in-home use | EN 55022:2010
  - EN 55032:2012
  Note 2.3 | Date expired
  (9.10.2016) |
| Cenelec | EN 55011:2009
  Industrial, scientific and medical equipment — Radio-frequency disturbance characteristics — Limits and methods of measurement
  CISPR 11:2009 (Modified) | EN 55011:2007
  - A2:2007 | Date expired
  (1.9.2012) |
| | EN 55011:2009/A1:2010
  CISPR 11:2009/A1:2010 | Note 3 | Date expired
  (1.7.2013) |
| Cenelec | EN 55012:2007
  Vehicles, boats and internal combustion engines — Radio disturbance characteristics — Limits and methods of measurement for the protection of off-board receivers
  CISPR 12:2007 | EN 55012:2002
  - A1:2005 | Date expired
  (1.9.2010) |
| | EN 55012:2007/A1:2009
  CISPR 12:2007/A1:2009 | Note 3 | Date expired
  (1.7.2012) |
| EN 55012 is applicable for giving presumption of conformity under directive 2004/108/EC for those vehicles, boats and internal combustion engine-driven devices that are not within the scope of directives 95/54/EC, 97/24/EC, 2000/2/EC or 2004/104/EC. |
| Cenelec | EN 55013:2001
  Sound and television broadcast receivers and associated equipment — Radio disturbance characteristics — Limits and methods of measurement
  CISPR 13:2001 (Modified) | EN 55013:1990
  - A12:1994
  - A13:1996
  - A14:1999
  Note 2.1 | Date expired
  (1.9.2004) |
| | EN 55013:2001/A1:2003
  CISPR 13:2001/A1:2003 | Note 3 | Date expired
  (1.4.2006) |
| | EN 55013:2001/A2:2006
  CISPR 13:2001/A2:2006 | Note 3 | Date expired
  (1.3.2009) |
| Cenelec | EN 55013:2013
  Sound and television broadcast receivers and associated equipment — Radio disturbance characteristics — Limits and methods of measurement
  CISPR 13:2009 (Modified) | EN 55013:2001
  and its amendments | Date expired
  (22.4.2016) |
| Cenelec | EN 55014-1:2006
  Electromagnetic compatibility — Requirements for household appliances, electric tools and similar apparatus — Part 1: Emission
  CISPR 14-1:2005 | EN 55014-1:2000
  - A1:2001
  - A2:2002
  Note 2.1 | Date expired
  (1.9.2009) |
| | EN 55014-1:2006/A1:2009
  CISPR 14-1:2005/A1:2008 | Note 3 | Date expired
  (1.5.2012) |
| | EN 55014-1:2006/A2:2011
  CISPR 14-1:2005/A2:2011 | Note 3 | Date expired
  (16.8.2014) |
| Cenelec | EN 55014-2:1997
  Electromagnetic compatibility — Requirements for household appliances, electric tools and similar apparatus — Part 2: Immunity — Product family standard
  CISPR 14-2:1997 | EN 55104:1995
  Note 2.1 | Date expired
  (1.1.2001) |
| | EN 55014-2:1997/AC:1997 | | |
| | EN 55014-2:1997/A1:2001
  CISPR 14-2:1997/A1:2001 | Note 3 | Date expired
  (1.12.2004) |
| | EN 55014-2:1997/A2:2008
  CISPR 14-2:1997/A2:2008 | Note 3 | Date expired
  (1.9.2011) |
| Cenelec | EN 55015:2006
  Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment
  CISPR 15:2005 | EN 55015:2000
  - A1:2001
  - A2:2002
  Note 2.1 | Date expired
  (1.9.2009) |
| | EN 55015:2006/A1:2007
  CISPR 15:2005/A1:2006 | Note 3 | Date expired
  (1.5.2010) |
| | EN 55015:2006/A2:2009
  CISPR 15:2005/A2:2008 | Note 3 | Date expired
  (1.3.2012) |
| Cenelec | EN 55015:2013
  Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment
  CISPR 15:2013
  CISPR 15:2013/IS1:2013
  CISPR 15:2013/IS2:2013 | EN 55015:2006
  and its amendments | Date expired
  (12.6.2016) |
| Cenelec | EN 55020:2007
  Sound and television broadcast receivers and associated equipment — Immunity characteristics — Limits and methods of measurement
  CISPR 20:2006 | EN 55020:2002
  - A1:2003
  - A2:2005
  Note 2.1 | Date expired
  (1.12.2009) |
| | EN 55020:2007/A11:2011 | Note 3 | Date expired
  (1.1.2013) |
| Cenelec | EN 55022:2010
  Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement
  CISPR 22:2008 (Modified) | EN 55022:2006
  - A1:2007
  Note 2.1 | Date expired
  (1.12.2013) |
| | EN 55022:2010/AC:2011 | | |
| Cenelec | EN 55024:2010
  Information technology equipment — Immunity characteristics — Limits and methods of measurement
  CIS
  CISPR 24:2010 | EN 55024:1998
  - A1:2001
  - A2:2003 | Date expired
  (1.12.2013) |
| Cenelec | EN 55032:2012
  Electromagnetic compatibility of multimedia equipment — Emission requirements
  CIS
  CISPR 32:2012 | EN 55013:2013
  - EN 55022:2010
  - EN 55103-1:2009
  and its amendment
  Note 2.2 | Date expired
  (5.3.2017) |
| | EN 55032:2012/AC:2013 | | |
| Cenelec | EN 55103-1:2009
  Electromagnetic compatibility — Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use — Part 1: Emissions | EN 55103-1:1996
  Note 2.1 | Date expired
  (1.7.2012) |
| | EN 55103-1:2009/A1:2012 | Note 3 | Date expired
  (5.11.2015) |
| Cenelec | EN 55103-2:2009
  Electromagnetic compatibility — Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use — Part 2: Immunity | EN 55103-2:1996
  Note 2.1 | Date expired
  (1.7.2012) |
| Cenelec | EN 60034-1:2010
  Rotating electrical machines — Part 1: Rating and performance
  IEC 60034-1:2010 (Modified) | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.10.2013) |
| | EN 60034-1:2010/AC:2010 | | |
| Cenelec | EN 60204-31:1998
  Safety of machinery — Electrical equipment of machines — Part 31: Particular safety and EMC requirements for sewing machines, units and systems
  IEC 60204-31:1996 (Modified) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.6.2002) |
| | EN 60204-31:1998/AC:2000 | | |
| Cenelec | EN 60204-31:2013
  Safety of machinery — Electrical equipment of machines — Part 31: Particular safety and EMC requirements for sewing machines, units and systems
  IEC 60204-31:2013 | EN 60204-31:1998
  Note 2.1 | Date expired
  (28.5.2016) |
| Cenelec | EN 60255-26:2013
  Measuring relays and protection equipment — Part 26: Electromagnetic compatibility requirements
  IEC 60255-26:2013 | | |
| | EN 60255-26:2013/AC:2013 | | |
| Cenelec | EN 60439-1:1999
  Low-voltage switchgear and controlgear assemblies — Part 1: Type-tested and partially type-tested assemblies
  IEC 60439-1:1999 | EN 60439-1:1994
  - A11:1996
  Note 2.1 | Date expired
  (1.8.2002) |
| Cenelec | EN 60669-2-1:2004
  Switches for household and similar fixed electrical installations — Part 2-1: Particular requirements — Electronic switches
  IEC 60669-2-1:2002 (Modified)
  IEC 60669-2-1:2002/IS1:2011
  IEC 60669-2-1:2002/IS2:2012 | EN 60669-2-1:2000
  - A2:2001 | Date expired
  (1.7.2009) |
| | EN 60669-2-1:2004/AC:2007 | | |
| | EN 60669-2-1:2004/A1:2009
  IEC 60669-2-1:2002/A1:2008 (Modified) | Note 3 | Date expired
  (1.4.2012) |
| | EN 60669-2-1:2004/A12:2010 | Note 3 | Date expired
  (1.6.2013) |
| Cenelec | EN 60730-1:2000
  Automatic electrical controls for household and similar use — Part 1: General requirements
  IEC 60730-1:1999 (Modified) | EN 60730-1:1995
  and its amendments | |
| | EN 60730-1:2000/AC:2007 | | |
| | EN 60730-1:2000/A16:2007/AC:2010 | | |
| | EN 60730-1:2000/A1:2004
  IEC 60730-1:1999/A1:2003 (Modified) | Note 3 | Date expired
  (17.3.2005) |
| | EN 60730-1:2000/A16:2007 | Note 3 | Date expired
  (1.6.2010) |
| | EN 60730-1:2000/A2:2008
  IEC 60730-1:1999/A2:2007 (Modified) | Note 3 | Date expired
  (1.6.2011) |
| Cenelec | EN 60730-1:2011
  Automatic electrical controls for household and similar use — Part 1: General requirements
  IEC 60730-1:2010 (Modified) | EN 60730-1:2000
  and its amendments
  Note 2.1 | Date expired
  (1.10.2013) |
| Note on DOW: EN 60730-1:2000 to remain valid until all the Part 2’s which are used in conjunction with it have been withdrawn. |
| Cenelec | EN 60730-1:1995
  Automatic electrical controls for household and similar use — Part 1: General requirements
  IEC 60730-1:1993 (Modified) | | |
| | EN 60730-1:1995/AC:1997 | | |
| | EN 60730-1:1995/AC:2007 | | |
| | EN 60730-1:1995/A11:1996 | Note 3 | Date expired
  (1.1.1998) |
| | EN 60730-1:1995/A17:2000 | Note 3 | Date expired
  (1.10.2002) |
| Cenelec | EN 60730-2-5:2002
  Automatic electrical controls for household and similar use — Part 2-5: Particular requirements for automatic electrical burner control systems
  IEC 60730-2-5:2000 (Modified) | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.12.2008) |
| | EN 60730-2-5:2002/A1:2004
  IEC 60730-2-5:2000/A1:2004 (Modified) | Note 3 | Date expired
  (1.12.2008) |
| | EN 60730-2-5:2002/A11:2005 | Note 3 | Date expired
  (1.12.2008) |
| | EN 60730-2-5:2002/A2:2010
  IEC 60730-2-5:2000/A2:2008 (Modified) | Note 3 | Date expired
  (1.3.2013) |
| Cenelec | EN 60730-2-6:2008
  Automatic electrical controls for household and similar use — Part 2-6: Particular requirements for automatic electrical pressure sensing controls including mechanical requirements
  IEC 60730-2-6:2007 (Modified) | EN 60730-2-6:1995
  - A1:1997
  Note 2.1 | Date expired
  (1.7.2011) |
| Cenelec | EN 60730-2-7:2010
  Automatic electrical controls for household and similar use — Part 2-7: Particular requirements for timers and time switches
  IEC 60730-2-7:2008 (Modified) | EN 60730-2-7:1991
  - A1:1997 | Date expired
  (1.10.2013) |
| | EN 60730-2-7:2010/AC:2011 | | |
| Cenelec | EN 60730-2-8:2002
  Automatic electrical controls for household and similar use — Part 2-8: Particular requirements for electrically operated water valves, including mechanical requirements
  IEC 60730-2-8:2000 (Modified) | EN 60730-2-8:1995
  - A1:1997
  - A2:1997
  Note 2.1 | Date expired
  (1.12.2008) |
| | EN 60730-2-8:2002/A1:2003
  IEC 60730-2-8:2000/A1:2002 (Modified) | Note 3 | Date expired
  (1.12.2008) |
| Cenelec | EN 60730-2-9:2010
  Automatic electrical controls for household and similar use — Part 2-9: Particular requirements for temperature sensing controls
  IEC 60730-2-9:2008 (Modified) | EN 60730-2-9:2002
  - A1:2003
  - A2:2005 | Date expired
  (1.11.2013) |
| Cenelec | EN 60730-2-14:1997
  Automatic electrical controls for household and similar use — Part 2-14: Particular requirements for electric actuators
  IEC 60730-2-14:1995 (Modified) | EN 60730-1:1995
  and its amendments
  Note 2.1 | Date expired
  (1.6.2004) |
| | EN 60730-2-14:1997/A1:2001
  IEC 60730-2-14:1995/A1:2001 | Note 3 | Date expired
  (1.7.2008) |
| Cenelec | EN 60730-2-15:2010
  Automatic electrical controls for household and similar use — Part 2-15: Particular requirements for automatic electrical air flow, water flow and water level sensing controls
  IEC 60730-2-15:2008 (Modified) | EN 60730-2-18:1999
  Note 2.1 | Date expired
  (1.3.2013) |
| Cenelec | EN 60870-2-1:1996
  Telecontrol equipment and systems — Part 2: Operating conditions — Section 1: Power supply and electromagnetic compatibility
  IEC 60870-2-1:1995 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.9.1996) |
| Cenelec | EN 60945:2002
  Maritime navigation and radiocommunication equipment and systems — General requirements — Methods of testing and required test results
  IEC 60945:2002 | EN 60945:1997
  Note 2.1 | Date expired
  (1.10.2005) |
| Cenelec | EN 60947-1:2007
  Low-voltage switchgear and controlgear — Part 1: General rules
  IEC 60947-1:2007 | EN 60947-1:2004
  Note 2.1 | Date expired
  (1.7.2010) |
| | EN 60947-1:2007/A1:2011
  IEC 60947-1:2007/A1:2010 | Note 3 | Date expired
  (1.1.2014) |
| Cenelec | EN 60947-2:2006
  Low-voltage switchgear and controlgear — Part 2: Circuit-breakers
  IEC 60947-2:2006 | EN 60947-2:2003
  Note 2.1 | Date expired
  (1.7.2009) |
| | EN 60947-2:2006/A1:2009
  IEC 60947-2:2006/A1:2009 | Note 3 | Date expired
  (1.7.2012) |
| | EN 60947-2:2006/A2:2013
  IEC 60947-2:2006/A2:2013 | Note 3 | Date expired
  (7.3.2016) |
| Cenelec | EN 60947-3:2009
  Low-voltage switchgear and controlgear — Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units
  IEC 60947-3:2008 | EN 60947-3:1999
  - A1:2001 | Date expired
  (1.5.2012) |
| | EN 60947-3:2009/A1:2012
  IEC 60947-3:2008/A1:2012 | Note 3 | Date expired
  (21.3.2015) |
| Cenelec | EN 60947-4-1:2010
  Low-voltage switchgear and controlgear — Part 4-1: Contactors and motor-starters — Electromechanical contactors and motor-starters
  IEC 60947-4-1:2009 | EN 60947-4-1:2001
  - A1:2002
  - A2:2005 | Date expired
  (1.4.2013) |
| | EN 60947-4-1:2010/A1:2012
  IEC 60947-4-1:2009/A1:2012 | Note 3 | Date expired
  (24.8.2015) |
| Cenelec | EN 60947-4-2:2012
  Low-voltage switchgear and controlgear — Part 4-2: Contactors and motor-starters — AC semiconductor motor controllers and starters
  IEC 60947-4-2:2011 | EN 60947-4-2:2000
  EN 60947-4-2:1996# + A2:1998
  Note 2.1 | Date expired
  (22.6.2014) |
| Cenelec | EN 60947-4-3:2000
  Low-voltage switchgear and controlgear — Part 4-3: Contactors and motor-starters — AC semiconductor controllers and contactors for non-motor loads
  IEC 60947-4-3:1999 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.12.2002) |
| | EN 60947-4-3:2000/A1:2006
  IEC 60947-4-3:1999/A1:2006 | Note 3 | Date expired
  (1.11.2009) |
| | EN 60947-4-3:2000/A2:2011
  IEC 60947-4-3:1999/A2:2011 | Note 3 | Date expired
  (18.4.2014) |
| Cenelec | EN 60947-4-3:2014
  Low-voltage switchgear and controlgear — Part 4-3: Contactors and motor-starters — AC semiconductor controllers and contactors for non-motor loads
  IEC 60947-4-3:2014 | EN 60947-4-3:2000
  Note 2.1 | Date expired
  (11.6.2017) |
| Cenelec | EN 60947-5-1:2004
  Low-voltage switchgear and controlgear — Part 5-1: Control circuit devices and switching elements — Electromechanical control circuit devices
  IEC 60947-5-1:2003 | EN 60947-5-1:1997
  - A12:1999
  Note 2.1 | Date expired
  (1.5.2007) |
| | EN 60947-5-1:2004/AC:2005 | | |
| | EN 60947-5-1:2004/A1:2009
  IEC 60947-5-1:2003/A1:2009 | Note 3 | Date expired
  (1.5.2012) |
| Cenelec | EN 60947-5-2:2007
  Low-voltage switchgear and controlgear — Part 5-2: Control circuit devices and switching elements — Proximity switches
  IEC 60947-5-2:2007 | EN 60947-5-2:1998
  - A2:2004 | Date expired
  (1.11.2010) |
| | EN 60947-5-2:2007/A1:2012
  IEC 60947-5-2:2007/A1:2012 | Note 3 | Date expired
  (1.11.2015) |
| Cenelec | EN 60947-5-3:1999
  Low-voltage switchgear and controlgear — Part 5-3: Control circuit devices and switching elements — Requirements for proximity devices with defined behaviour under fault conditions (PDF)
  IEC 60947-5-3:1999 | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.5.2002) |
| | EN 60947-5-3:1999/A1:2005
  IEC 60947-5-3:1999/A1:2005 | Note 3 | Date expired
  (1.3.2008) |
| Cenelec | EN 60947-5-6:2000
  Low-voltage switchgear and controlgear — Part 5-6: Control circuit devices and switching elements — DC interface for proximity sensors and switching amplifiers (NAMUR)
  IEC 60947-5-6:1999 | EN 50227:1997
  Note 2.1 | Date expired
  (1.1.2003) |
| Cenelec | EN 60947-5-7:2003
  Low-voltage switchgear and controlgear — Part 5-7: Control circuit devices and switching elements — Requirements for proximity devices with analogue output
  IEC 60947-5-7:2003 | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.9.2006) |
| Cenelec | EN 60947-5-9:2007
  Low-voltage switchgear and controlgear — Part 5-9: Control circuit devices and switching elements — Flow rate switches
  IEC 60947-5-9:2006 | | |
| Cenelec | EN 60947-6-1:2005
  Low-voltage switchgear and controlgear — Part 6-1: Multiple function equipment — Transfer switching equipment
  IEC 60947-6-1:2005 | EN 60947-6-1:1991
  - A2:1997
  Note 2.1 | Date expired
  (1.10.2008) |
| | EN 60947-6-1:2005/A1:2014
  IEC 60947-6-1:2005/A1:2013 | Note 3 | Date expired
  (17.1.2017) |
| Cenelec | EN 60947-6-2:2003
  Low-voltage switchgear and controlgear — Part 6-2: Multiple function equipment — Control and protective switching devices (or equipment) (CPS)
  IEC 60947-6-2:2002 | EN 60947-6-2:1993
  - A1:1997
  Note 2.1 | Date expired
  (1.9.2005) |
| | EN 60947-6-2:2003/A1:2007
  IEC 60947-6-2:2002/A1:2007 | Note 3 | Date expired
  (1.3.2010) |
| Cenelec | EN 60947-8:2003
  Low-voltage switchgear and controlgear — Part 8: Control units for built-in thermal protection (PTC) for rotating electrical machines
  IEC 60947-8:2003 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2006) |
| | EN 60947-8:2003/A1:2006
  IEC 60947-8:2003/A1:2006 | Note 3 | Date expired
  (1.10.2009) |
| | EN 60947-8:2003/A2:2012
  IEC 60947-8:2003/A2:2011 | Note 3 | Date expired
  (22.6.2014) |
| Cenelec | EN 60974-10:2007
  Arc welding equipment — Part 10: Electromagnetic compatibility (EMC) requirements
  IEC 60974-10:2007 | EN 60974-10:2003
  Note 2.1 | Date expired
  (1.12.2010) |
| Cenelec | EN 60974-10:2014
  Arc welding equipment — Part 10: Electromagnetic compatibility (EMC) requirements
  IEC 60974-10:2014 | EN 60974-10:2007
  Note 2.1 | Date expired
  (13.3.2017) |
| Cenelec | EN 61000-3-2:2006
  Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current <= 16 A per phase)
  IEC 61000-3-2:2005 | EN 61000-3-2:2000
  - A2:2005
  Note 2.1 | Date expired
  (1.2.2009) |
| | EN 61000-3-2:2006/A2:2009
  IEC 61000-3-2:2005/A2:2009 | Note 3 | Date expired
  (1.7.2012) |
| | EN 61000-3-2:2006/A1:2009
  IEC 61000-3-2:2005/A1:2008 | Note 3 | Date expired
  (1.7.2012) |
| Cenelec | EN 61000-3-2:2014
  Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
  IEC 61000-3-2:2014 | EN 61000-3-2:2006
  Note 2.1 | Date expired
  (30.6.2017) |
| Cenelec | EN 61000-3-3:2008
  Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
  IEC 61000-3-3:2008 | EN 61000-3-3:1995 | Date expired
  (1.9.2011) |
| Cenelec | EN 61000-3-3:2013
  Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
  IEC 61000-3-3:2013 | EN 61000-3-3:2008
  Note 2.1 | Date expired
  (18.6.2016) |
| Cenelec | EN 61000-3-11:2000
  Electromagnetic compatibility (EMC) — Part 3-11: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems — Equipment with rated current <= 75 A and subject to conditional connection
  IEC 61000-3-11:2000 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.11.2003) |
| Cenelec | EN 61000-3-12:2011
  Electromagnetic compatibility (EMC) — Part 3-12: Limits — Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and <= 75 A per phase
  IEC 61000-3-12:2011
  IEC 61000-3-12:2011/IS1:2012 | EN 61000-3-12:2005
  Note 2.1 | Date expired
  (16.6.2014) |
| Cenelec | EN 61000-6-1:2007
  Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
  IEC 61000-6-1:2005 | EN 61000-6-1:2001
  Note 2.1 | Date expired
  (1.12.2009) |
| Cenelec | EN 61000-6-2:2005
  Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity for industrial environments
  IEC 61000-6-2:2005 | EN 61000-6-2:2001
  Note 2.1 | Date expired
  (1.6.2008) |
| | EN 61000-6-2:2005/AC:2005 | | |
| Cenelec | EN 61000-6-3:2007
  Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments
  IEC 61000-6-3:2006 | EN 61000-6-3:2001
  - A11:2004 | Date expired
  (1.12.2009) |
| | EN 61000-6-3:2007/A1:2011
  IEC 61000-6-3:2006/A1:2010 | Note 3 | Date expired
  (12.1.2014) |
| | EN 61000-6-3:2007/A1:2011/AC:2012 | | |
| Cenelec | EN 61000-6-4:2007
  Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments
  IEC 61000-6-4:2006 | EN 61000-6-4:2001
  Note 2.1 | Date expired
  (1.12.2009) |
| | EN 61000-6-4:2007/A1:2011
  IEC 61000-6-4:2006/A1:2010 | Note 3 | Date expired
  (12.1.2014) |
| Cenelec | EN 61008-1:2004
  Residual current operated circuit-breakers without integral overcurrent protection for household and similar uses (RCCB's) — Part 1: General rules
  IEC 61008-1:1996 (Modified)
  IEC 61008-1:1996/A1:2002 (Modified) | EN 61008-1:1994
  - A2:1995
  - A14:1998 | Date expired
  (1.4.2009) |
| | EN 61008-1:2004/A12:2009 | Note 3 | Date expired
  (1.12.2011) |
| Cenelec | EN 61008-1:2012
  Residual current operated circuit-breakers without integral overcurrent protection for household and similar uses (RCCBs) — Part 1: General rules
  IEC 61008-1:2010 (Modified) | EN 61008-1:2004
  and its amendment | Date expired
  (18.6.2017) |
| Cenelec | EN 61009-1:2004
  Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBO's) — Part 1: General rules
  IEC 61
  IEC 61009-1:1996 (Modified)
  IEC 61009-1:1996/A1:2002 (Modified) | EN 61009-1:1994
  - A1:1995
  - A14:1998 | Date expired
  (1.4.2009) |
| | EN 61009-1:2004/AC:2006 | | |
| | EN 61009-1:2004/A12:2009 | Note 3 | Date expired
  (1.12.2011) |
| | EN 61009-1:2004/A13:2009 | Note 3 | Date expired
  (1.12.2011) |
| Cenelec | EN 61009-1:2012
  Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBOs) — Part 1: General rules
  IEC 61009-1:2010 (Modified) | EN 61009-1:2004
  and its amendments | Date expired
  (18.6.2017) |
| Cenelec | EN 61131-2:2007
  Programmable controllers — Part 2: Equipment requirements and tests
  IEC 61131-2:2007 | EN 61131-2:2003
  Note 2.1 | Date expired
  (1.8.2010) |
| Cenelec | EN 61204-3:2000
  Low voltage power supplies, d.c. output — Part 3: Electromagnetic compatibility (EMC)
  IEC 61204-3:2000 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.11.2003) |
| Cenelec | EN 61326-1:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements
  IEC 61326-1:2005 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.2.2009) |
| Cenelec | EN 61326-1:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements
  IEC 61326-1:2012 | EN 61326-1:2006
  Note 2.1 | Date expired
  (14.8.2015) |
| Cenelec | EN 61326-2-1:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-1: Particular requirements — Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
  IEC 61326-2-1:2005 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.2.2009) |
| Cenelec | EN 61326-2-1:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-1: Particular requirements — Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
  IEC 61326-2-1:2012 | EN 61326-2-1:2006
  Note 2.1 | Date expired
  (6.11.2015) |
| Cenelec | EN 61326-2-2:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-2: Particular requirements — Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems
  IEC 61326-2-2:2005 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.2.2009) |
| Cenelec | EN 61326-2-2:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-2: Particular requirements — Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems
  IEC 61326-2-2:2012 | EN 61326-2-2:2006
  Note 2.1 | Date expired
  (6.11.2015) |
| Cenelec | EN 61326-2-3:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-3: Particular requirements — Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning
  IEC 61326-2-3:2006 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.8.2009) |
| Cenelec | EN 61326-2-3:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-3: Particular requirements — Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning
  IEC 61326-2-3:2012 | EN 61326-2-3:2006
  Note 2.1 | Date expired
  (14.8.2015) |
| Cenelec | EN 61326-2-4:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-4: Particular requirements — Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9
  IEC 6132
  IEC 61326-2-4:2006 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.11.2009) |
| Cenelec | EN 61326-2-4:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-4: Particular requirements — Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9
  IEC 61326-2-4:2012 | EN 61326-2-4:2006
  Note 2.1 | Date expired
  (14.8.2015) |
| Cenelec | EN 61326-2-5:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-5: Particular requirements — Test configurations, operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1, CP 3/2
  IEC 61326-2-5:2006 | EN 61326:1997
  - A1:1998
  - A2:2001
  - A3:2003
  Note 2.1 | Date expired
  (1.9.2009) |
| Cenelec | EN 61326-2-5:2013
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-5: Particular requirements — Test configurations, operational conditions and performance criteria for devices with field bus interfaces according to IEC 61784-1
  IEC 61326-2-5:2012 | EN 61326-2-5:2006
  Note 2.1 | Date expired
  (6.11.2015) |
| Cenelec | EN 61439-1:2011
  Low-voltage switchgear and controlgear assemblies — Part 1: General rules
  IEC 61439-1:2011 | EN 61439-1:2009
  Note 2.1 | Date expired
  (23.9.2014) |
| Cenelec | EN 61439-1:2009
  Low-voltage switchgear and controlgear assemblies — Part 1: General rules
  IEC 61439-1:2009 (Modified) | EN 60439-1:1999
  Note 2.1 | Date expired
  (1.11.2014) |
| | EN 61439-1:2009/AC:2013 | | |
| EN 61439-1:2009 does not give presumption of conformity without another part of the standard. |
| Cenelec | EN 61439-2:2011
  Low-voltage switchgear and controlgear assemblies — Part 2: Power switchgear and controlgear assemblies
  IEC 61439-2:2011 | EN 61439-2:2009
  Note 2.1 | Date expired
  (23.9.2014) |
| Cenelec | EN 61439-2:2009
  Low-voltage switchgear and controlgear assemblies — Part 2: Power switchgear and controlgear assemblies
  IEC 61439-2:2009 | | |
| Cenelec | EN 61439-3:2012
  Low-voltage switchgear and controlgear assemblies — Part 3: Distribution boards intended to be operated by ordinary persons (DBO)
  IEC 61439-3:2012 | | |
| Cenelec | EN 61439-4:2013
  Low-voltage switchgear and controlgear assemblies — Part 4: Particular requirements for assemblies for construction sites (ACS)
  IEC 61439-4:2012 | | |
| Cenelec | EN 61439-5:2011
  Low-voltage switchgear and controlgear assemblies — Part 5: Assemblies for power distribution in public networks
  IEC 61439-5:2010 | | |
| Cenelec | EN 61439-6:2012
  Low-voltage switchgear and controlgear assemblies — Part 6: Busbar trunking systems (busways)
  IEC 61439-6:2012 | | |
| Cenelec | EN 61543:1995
  Residual current-operated protective devices (RCDs) for household and similar use — Electromagnetic compatibility
  IEC 61543:1995 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (4.7.1998) |
| | EN 61543:1995/AC:1997 | | |
| | EN 61543:1995/A11:2003/AC:2004 | | |
| | EN 61543:1995/A11:2003
  IEC 61543:1995/A1:2004 | Note 3 | Date expired
  (1.3.2007) |
| | EN 61543:1995/A12:2005 | Note 3 | Date expired
  (1.3.2008) |
| | EN 61543:1995/A2:2006
  IEC 61543:1995/A2:2005 | Note 3 | Date expired
  (1.12.2008) |
| Cenelec | EN 61547:2009
  Equipment for general lighting purposes — EMC immunity requirements
  IEC 61547:2009
  IEC 61547:2009/IS1:2013 | EN 61547:1995 | Date expired
  (1.7.2012) |
| Cenelec | EN 61557-12:2008
  Electrical safety in low voltage distribution systems up to 1  000 V a.c. and 1  500 V d.c. — Equipment for testing, measuring or monitoring of protective measures — Part 12: Performance measuring and monitoring devices (PMD)
  IEC 61557-12:2007 | | |
| Cenelec | EN 61800-3:2004
  Adjustable speed electrical power drive systems — Part 3: EMC requirements and specific test methods
  IEC 61800-3:2004 | EN 61800-3:1996
  - A11:2000
  Note 2.1 | Date expired
  (1.10.2007) |
| | EN 61800-3:2004/A1:2012
  IEC 61800-3:2004/A1:2011 | Note 3 | Date expired
  (19.12.2014) |
| Cenelec | EN 61812-1:2011
  Time relays for industrial and residential use — Part 1: Requirements and tests
  IEC 61812-1:2011 | EN 61812-1:1996
  Note 2.1 | Date expired
  (29.6.2014) |
| Cenelec | EN 62020:1998
  Electrical accessories — Residual current monitors for household and similar uses (RCMs)
  IEC 62020:1998 | | |
| | EN 62020:1998/A1:2005
  IEC 62020:1998/A1:2003 (Modified) | Note 3 | Date expired
  (1.3.2008) |
| Cenelec | EN 62026-1:2007
  Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 1: General rules
  IEC 62026-1:2007 | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.9.2010) |
| EN 62026-1:2007 does not give presumption of conformity without another part of the standard. |
| Cenelec | EN 62026-2:2013
  Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 2: Actuator sensor interface (AS-i)
  IEC 62026-2:2008 (Modified) | EN 50295:1999
  Note 2.1 | Date expired
  (3.12.2015) |
| Cenelec | EN 62026-3:2009
  Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 3: DeviceNet
  IEC 62026-3:2008 | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.5.2012) |
| Cenelec | EN 62026-7:2013
  Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 7: CompoNet
  IEC 62026-7:2010 (Modified) | | |
| Cenelec | EN 62040-2:2006
  Uninterruptible power systems (UPS) — Part 2: Electromagnetic compatibility (EMC) requirements
  IEC 62
  IEC 62040-2:2005 | EN 50091-2:1995
  Note 2.1 | Date expired
  (1.10.2008) |
| | EN 62040-2:2006/AC:2006 | | |
| Cenelec | EN 62052-11:2003
  Electricity metering equipment (AC) — General requirements, tests and test conditions — Part 11: Metering equipment
  IEC 62052-11:2003 | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.3.2006) |
| EN 62052-11:2003 does not give presumption of conformity without a part of the EN 62053 series. |
| Cenelec | EN 62052-21:2004
  Electricity metering equipment (a.c.) — General requirements, tests and test conditions — Part 21: Tariff and load control equipment
  IEC 62052-21:2004 | EN 61037:1992
  - A1:1996
  - A2:1998
  - EN 61038:1992
  - A1:1996
  - A2:1998
  Note 2.1 | Date expired
  (1.7.2007) |
| EN 62052-21:2004 does not give presumption of conformity without a part of the EN 62054 series. |
| Cenelec | EN 62053-11:2003
  Electricity metering equipment (a.c.) — Particular requirements — Part 11: Electromechanical meters for active energy (classes 0,5, 1 and 2)
  IEC 62053-11:2003 | EN 60521:1995
  Note 2.1 | Date expired
  (1.3.2006) |
| Cenelec | EN 62053-21:2003
  Electricity metering equipment (a.c.) — Particular requirements — Part 21: Static meters for active energy (classes 1 and 2)
  IEC 62053-21:2003 | EN 61036:1996
  - A1:2000
  Note 2.1 | Date expired
  (1.3.2006) |
| Cenelec | EN 62053-22:2003
  Electricity metering equipment (a.c.) — Particular requirements — Part 22: Static meters for active energy (classes 0,2 S and 0,5 S)
  IEC 62053-22:2003 | EN 60687:1992
  Note 2.1 | Date expired
  (1.3.2006) |
| Cenelec | EN 62053-23:2003
  Electricity metering equipment (a.c.) — Particular requirements — Part 23: Static meters for reactive energy (classes 2 and 3)
  IEC 62053-23:2003 | EN 61268:1996
  Note 2.1 | Date expired
  (1.3.2006) |
| Cenelec | EN 62054-11:2004
  Electricity metering (a.c.) — Tariff and load control — Part 11: Particular requirements for electronic ripple control receivers
  IEC 62054-11:2004 | EN 61037:1992
  - A1:1996
  - A2:1998
  Note 2.1 | Date expired
  (1.7.2007) |
| Cenelec | EN 62054-21:2004
  Electricity metering (a.c.) — Tariff and load control — Part 21: Particular requirements for time switches
  IEC 62054-21:2004 | EN 61038:1992
  - A1:1996
  - A2:1998
  Note 2.1 | Date expired
  (1.7.2007) |
| Cenelec | EN 62135-2:2008
  Resistance welding equipment — Part 2: Electromagnetic compatibility (EMC) requirements
  IEC 62135-2:2007 | EN 50240:2004
  Note 2.1 | Date expired
  (1.2.2011) |
| Cenelec | EN 62310-2:2007
  Static transfer systems (STS) — Part 2: Electromagnetic compatibility (EMC) requirements
  IEC 62310-2:2006 (Modified) | Relevant generic standard(s)
  Note 2.1 | Date expired
  (1.9.2009) |
| Cenelec | EN 62423:2009
  Type B residual current operated circuit-breakers with and without integral overcurrent protection for household and similar uses (Type B RCCBs and Type B RCBOs)
  IEC 62423:2007 (Modified) | | |
| Cenelec | EN 62423:2012
  Type F and type B residual current operated circuit-breakers with and without integral overcurrent protection for household and similar uses
  IEC
  IEC 62423:2009 (Modified) | EN 62423:2009
  Note 2.1 | Date expired
  (19.6.2017) |
| Cenelec | EN 62586-1:2014
  Power quality measurement in power supply systems — Part 1: Power quality instruments (PQI)
  IEC 62586-1:2013 | | |
| Cenelec | EN 62586-2:2014
  Power quality measurement in power supply systems — Part 2: Functional tests and uncertainty requirements
  IEC 62586-2:2013 | | |
| Cenelec | EN 62606:2013
  General requirements for arc fault detection devices
  IEC
  IEC 62606:2013 (Modified) | | |
| ETSI | EN 300 386 V1.4.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements | EN 300 386 V1.3.3
  Note 2.1 | Date expired
  (31.7.2011) |
| ETSI | EN 300 386 V1.5.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements | EN 300 386 V1.4.1
  Note 2.1 | Date expired
  (31.1.2014) |
| ETSI | EN 300 386 V1.6.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements | EN 300 386 V1.5.1
  Note 2.1 | Date expired
  (30.11.2015) |
| ETSI | EN 301 489-1 V1.9.2
  Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements | EN 301 489-1 V1.8.1
  Note 2.1 | Date expired
  (30.6.2013) |
| ETSI | EN 301 489-34 V1.1.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones | | |
| ETSI | EN 301 489-34 V1.3.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones | EN 301 489-34 V1.1.1
  Note 2.1 | Date expired
  (28.2.2014) |
| ETSI | EN 301 489-34 V1.4.1
  Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones | EN 301 489-34 V1.3.1
  Note 2.1 | Date expired
  (28.2.2015) |

ESO (1)

Reference and title of the standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

CEN

EN 617:2001+A1:2010

Continuous handling equipment and systems — Safety and EMC requirements for the equipment for the storage of bulk materials in silos, bunkers, bins and hoppers

EN 617:2001

Note 2.1

Date expired

(30.6.2011)

CEN

EN 618:2002+A1:2010

Continuous handling equipment and systems — Safety and EMC requirements for equipment for mechanical handling of bulk materials except fixed belt conveyors

EN 618:2002

Note 2.1

Date expired

(30.6.2011)

CEN

EN 619:2002+A1:2010

Continuous handling equipment and systems — Safety and EMC requirements for equipment for mechanical handling of unit loads

EN 619:2002

Note 2.1

Date expired

(30.4.2011)

CEN

EN 620:2002+A1:2010

Continuous handling equipment and systems — Safety and EMC requirements for fixed belt conveyors for bulk materials

EN 620:2002

Note 2.1

Date expired

(30.6.2011)

CEN

EN 1155:1997

Building hardware — Electrically powered hold-open devices for swing doors — Requirements and test methods

CEN

EN 12015:2014

Electromagnetic compatibility — Standard family product for lifts, escalators and moving walks — Emission

EN 12015:2004

Note 2.1

Date expired

(30.9.2014)

CEN

EN 12016:2013

Electromagnetic compatibility — Product family standard for lifts, escalators and moving walks — Immunity

EN 12016:2004+A1:2008

Note 2.1

Date expired

(28.2.2014)

CEN

EN 12895:2000

Industrial trucks — Electromagnetic compatibility

CEN

EN 13241-1:2003+A1:2011

Industrial, commercial and garage doors and gates — Product standard — Part 1: Products without fire resistance or smoke control characteristics

EN 13241-1:2003

Note 2.1

Date expired

(31.10.2011)

CEN

EN 13309:2010

Construction machinery — Electromagnetic compatibility of machines with internal power supply

EN 13309:2000

Note 2.1

Date expired

(31.1.2011)

CEN

EN 14010:2003+A1:2009

Safety of machinery — Equipment for power driven parking of motor vehicles — Safety and EMC requirements for design, manufacturing, erection and commissioning stages

EN 14010:2003

Note 2.1

Date expired

(31.1.2010)

CEN

EN ISO 14982:2009

Agricultural and forestry machinery — Electromagnetic compatibility — Test methods and acceptance criteria (ISO 14982:1998)

EN ISO 14982:1998

Note 2.1

Date expired

(28.12.2009)

CEN

EN 16361:2013

Power operated pedestrian doors — Product standard, performance characteristics — Pedestrian doorsets, other than swing type, initially designed for installation with power operation without resistance to fire and smoke leakage characteristics

Cenelec

EN 50065-1:2011

Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 1: General requirements, frequency bands and electromagnetic disturbances

EN 50065-1:2001

- A1:2010

Note 2.1

Date expired

(21.3.2014)

Cenelec

EN 50065-2-1:2003

Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-1: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 95 kHz to 148,5 kHz and intended for use in residential, commercial and light industrial environments

Relevant generic standard(s)

Note 2.3

Date expired

(1.10.2004)

EN 50065-2-1:2003/AC:2003

EN 50065-2-1:2003/A1:2005

Note 3

Date expired

(1.7.2008)

Cenelec

EN 50065-2-2:2003

Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-2: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 95 kHz to 148,5 kHz and intended for use in industrial environments

Relevant generic standard(s)

Note 2.3

Date expired

(1.10.2004)

EN 50065-2-2:2003/AC:2003

EN 50065-2-2:2003/A1:2005/AC:2006

EN 50065-2-2:2003/A1:2005

Note 3

Date expired

(1.7.2008)

Cenelec

EN 50065-2-3:2003

Signalling on low-voltage electrical installations in the frequency range 3 kHz to 148,5 kHz — Part 2-3: Immunity requirements for mains communications equipment and systems operating in the range of frequencies 3 kHz to 95 kHz and intended for use by electricity suppliers and distributors

Relevant generic standard(s)

Note 2.1

Date expired

(1.8.2004)

EN 50065-2-3:2003/AC:2003

EN 50065-2-3:2003/A1:2005

Note 3

Date expired

(1.7.2008)

Cenelec

EN 50083-2:2012

Cable networks for television signals, sound signals and interactive services — Part 2: Electromagnetic compatibility for equipment

EN 50083-2:2006

Note 2.1

Date expired

(21.6.2013)

Cenelec

EN 50121-1:2006

Railway applications — Electromagnetic compatibility — Part 1: General

Relevant generic standard(s)

Note 2.1

Date expired

(1.7.2009)

EN 50121-1:2006/AC:2008

Cenelec

EN 50121-2:2006

Railway applications — Electromagnetic compatibility — Part 2: Emission of the whole railway system to the outside world

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2009)

EN 50121-2:2006/AC:2008

Cenelec

EN 50121-3-1:2006

Railway applications — Electromagnetic compatibility — Part 3-1: Rolling stock — Train and complete vehicle

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2009)

EN 50121-3-1:2006/AC:2008

Cenelec

EN 50121-3-2:2006

Railway applications — Electromagnetic compatibility — Part 3-2: Rolling stock — Apparatus

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2009)

EN 50121-3-2:2006/AC:2008

Cenelec

EN 50121-4:2006

Railway applications — Electromagnetic compatibility — Part 4: Emission and immunity of the signalling and telecommunications apparatus

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2009)

EN 50121-4:2006/AC:2008

Cenelec

EN 50121-5:2006

Railway applications — Electromagnetic compatibility — Part 5: Emission and immunity of fixed power supply installations and apparatus

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2009)

EN 50121-5:2006/AC:2008

Cenelec

EN 50130-4:2011

Alarm systems — Part 4: Electromagnetic compatibility — Product family standard: Immunity requirements for components of fire, intruder, hold up, CCTV, access control and social alarm systems

EN 50130-4:1995

and its amendments

Note 2.2

Date expired

(13.6.2014)

Cenelec

EN 50148:1995

Electronic taximeters

Relevant generic standard(s)

Note 2.3

Date expired

(15.12.1995)

Cenelec

EN 50270:2006

Electromagnetic compatibility — Electrical apparatus for the detection and measurement of combustible gases, toxic gases or oxygen

EN 50270:1999

Note 2.3

Date expired

(1.6.2009)

Cenelec

EN 50293:2000

Electromagnetic compatibility — Road traffic signal systems — Product standard

Relevant generic standard(s)

Note 2.3

Date expired

(1.4.2003)

Cenelec

EN 50293:2012

Road traffic signal systems — Electromagnetic compatibility

EN 50293:2000

Note 2.1

Date expired

(11.5.2015)

Cenelec

EN 50295:1999

Low-voltage switchgear and controlgear — Controller and device interface systems — Actuator Sensor interface (AS-i)

Relevant generic standard(s)

Note 2.1

Date expired

(1.12.1999)

Cenelec

EN 50370-1:2005

Electromagnetic compatibility (EMC) — Product family standard for machine tools — Part 1: Emission

Relevant generic standard(s)

Note 2.1

Date expired

(1.2.2008)

Cenelec

EN 50370-2:2003

Electromagnetic compatibility (EMC) — Product family standard for machine tools — Part 2: Immunity

Relevant generic standard(s)

Note 2.1

Date expired

(1.11.2005)

Cenelec

EN 50412-2-1:2005

Power line communication apparatus and systems used in low-voltage installations in the frequency range 1,6 MHz to 30 MHz — Part 2-1: Residential, commercial and industrial environment — Immunity requirements

Relevant generic standard(s)

Note 2.1

Date expired

(1.4.2008)

EN 50412-2-1:2005/AC:2009

Cenelec

EN 50428:2005

Switches for household and similar fixed electrical installations — Collateral standard — Switches and related accessories for use in home and building electronic systems (HBES)

Relevant generic standard(s)

Note 2.1

Date expired

(1.1.2008)

EN 50428:2005/A2:2009

Note 3

Date expired

(1.6.2012)

EN 50428:2005/A1:2007

Note 3

Date expired

(1.10.2010)

Cenelec

EN 50470-1:2006

Electricity metering equipment (a.c.) — Part 1: General requirements, tests and test conditions — Metering equipment (class indexes A, B and C)

IEC 62052-11:2003

Relevant generic standard(s)

Note 2.1

Date expired

(1.5.2009)

Cenelec

EN 50490:2008

Electrical installations for lighting and beaconing of aerodromes — Technical requirements for aeronautical ground lighting control and monitoring systems — Units for selective switching and monitoring of individual lamps

Relevant generic standard(s)

Note 2.1

Date expired

(1.4.2011)

Cenelec

EN 50491-5-1:2010

General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-1: EMC requirements, conditions and test set-up

EN 50090-2-2:1996

- A2:2007

Note 2.1

Date expired

(1.4.2013)

Cenelec

EN 50491-5-2:2010

General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-2: EMC requirements for HBES/BACS used in residential, commercial and light industry environment

EN 50090-2-2:1996

- A2:2007

Note 2.1

Date expired

(1.4.2013)

Cenelec

EN 50491-5-3:2010

General requirements for Home and Building Electronic Systems (HBES) and Building Automation and Control Systems (BACS) — Part 5-3: EMC requirements for HBES/BACS used in industry environment

EN 50090-2-2:1996

- A2:2007

Note 2.1

Date expired

(1.4.2013)

Cenelec

EN 50498:2010

Electromagnetic compatibility (EMC) — Product family standard for aftermarket electronic equipment in vehicles

Relevant generic standard(s)

Note 2.1

Date expired

(1.7.2013)

Cenelec

EN 50512:2009

Electrical installations for lighting and beaconing of aerodromes — Advanced Visual Docking Guidance Systems (A-VDGS)

Relevant generic standard(s)

Note 2.3

Date expired

(1.12.2011)

Cenelec

EN 50529-1:2010

EMC Network Standard — Part 1: Wire-line telecommunications networks using telephone wires

Cenelec

EN 50529-2:2010

EMC Network Standard — Part 2: Wire-line telecommunications networks using coaxial cables

Cenelec

EN 50550:2011

Power frequency overvoltage protective device for household and similar applications (POP)

EN 50550:2011/A1:2014

Note 3

Date expired

(28.7.2017)

EN 50550:2011/AC:2012

Cenelec

EN 50557:2011

Requirements for automatic reclosing devices (ARDs) for circuit breakers-RCBOs-RCCBs for household and similar uses

Cenelec

EN 50561-1:2013

Power line communication apparatus used in low-voltage installations — Radio disturbance characteristics — Limits and methods of measurement — Part 1: Apparatus for in-home use

EN 55022:2010

- EN 55032:2012

Note 2.3

Date expired

(9.10.2016)

Cenelec

EN 55011:2009

Industrial, scientific and medical equipment — Radio-frequency disturbance characteristics — Limits and methods of measurement

CISPR 11:2009 (Modified)

EN 55011:2007

- A2:2007

Date expired

(1.9.2012)

EN 55011:2009/A1:2010

CISPR 11:2009/A1:2010

Note 3

Date expired

(1.7.2013)

Cenelec

EN 55012:2007

Vehicles, boats and internal combustion engines — Radio disturbance characteristics — Limits and methods of measurement for the protection of off-board receivers

CISPR 12:2007

EN 55012:2002

- A1:2005

Date expired

(1.9.2010)

EN 55012:2007/A1:2009

CISPR 12:2007/A1:2009

Note 3

Date expired

(1.7.2012)

EN 55012 is applicable for giving presumption of conformity under directive 2004/108/EC for those vehicles, boats and internal combustion engine-driven devices that are not within the scope of directives 95/54/EC, 97/24/EC, 2000/2/EC or 2004/104/EC.

Cenelec

EN 55013:2001

Sound and television broadcast receivers and associated equipment — Radio disturbance characteristics — Limits and methods of measurement

CISPR 13:2001 (Modified)

EN 55013:1990

- A12:1994

- A13:1996

- A14:1999

Note 2.1

Date expired

(1.9.2004)

EN 55013:2001/A1:2003

CISPR 13:2001/A1:2003

Note 3

Date expired

(1.4.2006)

EN 55013:2001/A2:2006

CISPR 13:2001/A2:2006

Note 3

Date expired

(1.3.2009)

Cenelec

EN 55013:2013

Sound and television broadcast receivers and associated equipment — Radio disturbance characteristics — Limits and methods of measurement

CISPR 13:2009 (Modified)

EN 55013:2001

and its amendments

Date expired

(22.4.2016)

Cenelec

EN 55014-1:2006

Electromagnetic compatibility — Requirements for household appliances, electric tools and similar apparatus — Part 1: Emission

CISPR 14-1:2005

EN 55014-1:2000

- A1:2001

- A2:2002

Note 2.1

Date expired

(1.9.2009)

EN 55014-1:2006/A1:2009

CISPR 14-1:2005/A1:2008

Note 3

Date expired

(1.5.2012)

EN 55014-1:2006/A2:2011

CISPR 14-1:2005/A2:2011

Note 3

Date expired

(16.8.2014)

Cenelec

EN 55014-2:1997

Electromagnetic compatibility — Requirements for household appliances, electric tools and similar apparatus — Part 2: Immunity — Product family standard

CISPR 14-2:1997

EN 55104:1995

Note 2.1

Date expired

(1.1.2001)

EN 55014-2:1997/AC:1997

EN 55014-2:1997/A1:2001

CISPR 14-2:1997/A1:2001

Note 3

Date expired

(1.12.2004)

EN 55014-2:1997/A2:2008

CISPR 14-2:1997/A2:2008

Note 3

Date expired

(1.9.2011)

Cenelec

EN 55015:2006

Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment

CISPR 15:2005

EN 55015:2000

- A1:2001

- A2:2002

Note 2.1

Date expired

(1.9.2009)

EN 55015:2006/A1:2007

CISPR 15:2005/A1:2006

Note 3

Date expired

(1.5.2010)

EN 55015:2006/A2:2009

CISPR 15:2005/A2:2008

Note 3

Date expired

(1.3.2012)

Cenelec

EN 55015:2013

Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment

CISPR 15:2013

CISPR 15:2013/IS1:2013

CISPR 15:2013/IS2:2013

EN 55015:2006

and its amendments

Date expired

(12.6.2016)

Cenelec

EN 55020:2007

Sound and television broadcast receivers and associated equipment — Immunity characteristics — Limits and methods of measurement

CISPR 20:2006

EN 55020:2002

- A1:2003

- A2:2005

Note 2.1

Date expired

(1.12.2009)

EN 55020:2007/A11:2011

Note 3

Date expired

(1.1.2013)

Cenelec

EN 55022:2010

Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement

CISPR 22:2008 (Modified)

EN 55022:2006

- A1:2007

Note 2.1

Date expired

(1.12.2013)

EN 55022:2010/AC:2011

Cenelec

EN 55024:2010

Information technology equipment — Immunity characteristics — Limits and methods of measurement

CIS

CISPR 24:2010

EN 55024:1998

- A1:2001

- A2:2003

Date expired

(1.12.2013)

Cenelec

EN 55032:2012

Electromagnetic compatibility of multimedia equipment — Emission requirements

CIS

CISPR 32:2012

EN 55013:2013

- EN 55022:2010

- EN 55103-1:2009

and its amendment

Note 2.2

Date expired

(5.3.2017)

EN 55032:2012/AC:2013

Cenelec

EN 55103-1:2009

Electromagnetic compatibility — Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use — Part 1: Emissions

EN 55103-1:1996

Note 2.1

Date expired

(1.7.2012)

EN 55103-1:2009/A1:2012

Note 3

Date expired

(5.11.2015)

Cenelec

EN 55103-2:2009

Electromagnetic compatibility — Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use — Part 2: Immunity

EN 55103-2:1996

Note 2.1

Date expired

(1.7.2012)

Cenelec

EN 60034-1:2010

Rotating electrical machines — Part 1: Rating and performance

IEC 60034-1:2010 (Modified)

Relevant generic standard(s)

Note 2.1

Date expired

(1.10.2013)

EN 60034-1:2010/AC:2010

Cenelec

EN 60204-31:1998

Safety of machinery — Electrical equipment of machines — Part 31: Particular safety and EMC requirements for sewing machines, units and systems

IEC 60204-31:1996 (Modified)

Relevant generic standard(s)

Note 2.3

Date expired

(1.6.2002)

EN 60204-31:1998/AC:2000

Cenelec

EN 60204-31:2013

Safety of machinery — Electrical equipment of machines — Part 31: Particular safety and EMC requirements for sewing machines, units and systems

IEC 60204-31:2013

EN 60204-31:1998

Note 2.1

Date expired

(28.5.2016)

Cenelec

EN 60255-26:2013

Measuring relays and protection equipment — Part 26: Electromagnetic compatibility requirements

IEC 60255-26:2013

EN 60255-26:2013/AC:2013

Cenelec

EN 60439-1:1999

Low-voltage switchgear and controlgear assemblies — Part 1: Type-tested and partially type-tested assemblies

IEC 60439-1:1999

EN 60439-1:1994

- A11:1996

Note 2.1

Date expired

(1.8.2002)

Cenelec

EN 60669-2-1:2004

Switches for household and similar fixed electrical installations — Part 2-1: Particular requirements — Electronic switches

IEC 60669-2-1:2002 (Modified)

IEC 60669-2-1:2002/IS1:2011

IEC 60669-2-1:2002/IS2:2012

EN 60669-2-1:2000

- A2:2001

Date expired

(1.7.2009)

EN 60669-2-1:2004/AC:2007

EN 60669-2-1:2004/A1:2009

IEC 60669-2-1:2002/A1:2008 (Modified)

Note 3

Date expired

(1.4.2012)

EN 60669-2-1:2004/A12:2010

Note 3

Date expired

(1.6.2013)

Cenelec

EN 60730-1:2000

Automatic electrical controls for household and similar use — Part 1: General requirements

IEC 60730-1:1999 (Modified)

EN 60730-1:1995

and its amendments

EN 60730-1:2000/AC:2007

EN 60730-1:2000/A16:2007/AC:2010

EN 60730-1:2000/A1:2004

IEC 60730-1:1999/A1:2003 (Modified)

Note 3

Date expired

(17.3.2005)

EN 60730-1:2000/A16:2007

Note 3

Date expired

(1.6.2010)

EN 60730-1:2000/A2:2008

IEC 60730-1:1999/A2:2007 (Modified)

Note 3

Date expired

(1.6.2011)

Cenelec

EN 60730-1:2011

Automatic electrical controls for household and similar use — Part 1: General requirements

IEC 60730-1:2010 (Modified)

EN 60730-1:2000

and its amendments

Note 2.1

Date expired

(1.10.2013)

Note on DOW: EN 60730-1:2000 to remain valid until all the Part 2’s which are used in conjunction with it have been withdrawn.

Cenelec

EN 60730-1:1995

Automatic electrical controls for household and similar use — Part 1: General requirements

IEC 60730-1:1993 (Modified)

EN 60730-1:1995/AC:1997

EN 60730-1:1995/AC:2007

EN 60730-1:1995/A11:1996

Note 3

Date expired

(1.1.1998)

EN 60730-1:1995/A17:2000

Note 3

Date expired

(1.10.2002)

Cenelec

EN 60730-2-5:2002

Automatic electrical controls for household and similar use — Part 2-5: Particular requirements for automatic electrical burner control systems

IEC 60730-2-5:2000 (Modified)

Relevant generic standard(s)

Note 2.1

Date expired

(1.12.2008)

EN 60730-2-5:2002/A1:2004

IEC 60730-2-5:2000/A1:2004 (Modified)

Note 3

Date expired

(1.12.2008)

EN 60730-2-5:2002/A11:2005

Note 3

Date expired

(1.12.2008)

EN 60730-2-5:2002/A2:2010

IEC 60730-2-5:2000/A2:2008 (Modified)

Note 3

Date expired

(1.3.2013)

Cenelec

EN 60730-2-6:2008

Automatic electrical controls for household and similar use — Part 2-6: Particular requirements for automatic electrical pressure sensing controls including mechanical requirements

IEC 60730-2-6:2007 (Modified)

EN 60730-2-6:1995

- A1:1997

Note 2.1

Date expired

(1.7.2011)

Cenelec

EN 60730-2-7:2010

Automatic electrical controls for household and similar use — Part 2-7: Particular requirements for timers and time switches

IEC 60730-2-7:2008 (Modified)

EN 60730-2-7:1991

- A1:1997

Date expired

(1.10.2013)

EN 60730-2-7:2010/AC:2011

Cenelec

EN 60730-2-8:2002

Automatic electrical controls for household and similar use — Part 2-8: Particular requirements for electrically operated water valves, including mechanical requirements

IEC 60730-2-8:2000 (Modified)

EN 60730-2-8:1995

- A1:1997

- A2:1997

Note 2.1

Date expired

(1.12.2008)

EN 60730-2-8:2002/A1:2003

IEC 60730-2-8:2000/A1:2002 (Modified)

Note 3

Date expired

(1.12.2008)

Cenelec

EN 60730-2-9:2010

Automatic electrical controls for household and similar use — Part 2-9: Particular requirements for temperature sensing controls

IEC 60730-2-9:2008 (Modified)

EN 60730-2-9:2002

- A1:2003

- A2:2005

Date expired

(1.11.2013)

Cenelec

EN 60730-2-14:1997

Automatic electrical controls for household and similar use — Part 2-14: Particular requirements for electric actuators

IEC 60730-2-14:1995 (Modified)

EN 60730-1:1995

and its amendments

Note 2.1

Date expired

(1.6.2004)

EN 60730-2-14:1997/A1:2001

IEC 60730-2-14:1995/A1:2001

Note 3

Date expired

(1.7.2008)

Cenelec

EN 60730-2-15:2010

Automatic electrical controls for household and similar use — Part 2-15: Particular requirements for automatic electrical air flow, water flow and water level sensing controls

IEC 60730-2-15:2008 (Modified)

EN 60730-2-18:1999

Note 2.1

Date expired

(1.3.2013)

Cenelec

EN 60870-2-1:1996

Telecontrol equipment and systems — Part 2: Operating conditions — Section 1: Power supply and electromagnetic compatibility

IEC 60870-2-1:1995

Relevant generic standard(s)

Note 2.3

Date expired

(1.9.1996)

Cenelec

EN 60945:2002

Maritime navigation and radiocommunication equipment and systems — General requirements — Methods of testing and required test results

IEC 60945:2002

EN 60945:1997

Note 2.1

Date expired

(1.10.2005)

Cenelec

EN 60947-1:2007

Low-voltage switchgear and controlgear — Part 1: General rules

IEC 60947-1:2007

EN 60947-1:2004

Note 2.1

Date expired

(1.7.2010)

EN 60947-1:2007/A1:2011

IEC 60947-1:2007/A1:2010

Note 3

Date expired

(1.1.2014)

Cenelec

EN 60947-2:2006

Low-voltage switchgear and controlgear — Part 2: Circuit-breakers

IEC 60947-2:2006

EN 60947-2:2003

Note 2.1

Date expired

(1.7.2009)

EN 60947-2:2006/A1:2009

IEC 60947-2:2006/A1:2009

Note 3

Date expired

(1.7.2012)

EN 60947-2:2006/A2:2013

IEC 60947-2:2006/A2:2013

Note 3

Date expired

(7.3.2016)

Cenelec

EN 60947-3:2009

Low-voltage switchgear and controlgear — Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units

IEC 60947-3:2008

EN 60947-3:1999

- A1:2001

Date expired

(1.5.2012)

EN 60947-3:2009/A1:2012

IEC 60947-3:2008/A1:2012

Note 3

Date expired

(21.3.2015)

Cenelec

EN 60947-4-1:2010

Low-voltage switchgear and controlgear — Part 4-1: Contactors and motor-starters — Electromechanical contactors and motor-starters

IEC 60947-4-1:2009

EN 60947-4-1:2001

- A1:2002

- A2:2005

Date expired

(1.4.2013)

EN 60947-4-1:2010/A1:2012

IEC 60947-4-1:2009/A1:2012

Note 3

Date expired

(24.8.2015)

Cenelec

EN 60947-4-2:2012

Low-voltage switchgear and controlgear — Part 4-2: Contactors and motor-starters — AC semiconductor motor controllers and starters

IEC 60947-4-2:2011

EN 60947-4-2:2000

EN 60947-4-2:1996# + A2:1998

Note 2.1

Date expired

(22.6.2014)

Cenelec

EN 60947-4-3:2000

Low-voltage switchgear and controlgear — Part 4-3: Contactors and motor-starters — AC semiconductor controllers and contactors for non-motor loads

IEC 60947-4-3:1999

Relevant generic standard(s)

Note 2.3

Date expired

(1.12.2002)

EN 60947-4-3:2000/A1:2006

IEC 60947-4-3:1999/A1:2006

Note 3

Date expired

(1.11.2009)

EN 60947-4-3:2000/A2:2011

IEC 60947-4-3:1999/A2:2011

Note 3

Date expired

(18.4.2014)

Cenelec

EN 60947-4-3:2014

Low-voltage switchgear and controlgear — Part 4-3: Contactors and motor-starters — AC semiconductor controllers and contactors for non-motor loads

IEC 60947-4-3:2014

EN 60947-4-3:2000

Note 2.1

Date expired

(11.6.2017)

Cenelec

EN 60947-5-1:2004

Low-voltage switchgear and controlgear — Part 5-1: Control circuit devices and switching elements — Electromechanical control circuit devices

IEC 60947-5-1:2003

EN 60947-5-1:1997

- A12:1999

Note 2.1

Date expired

(1.5.2007)

EN 60947-5-1:2004/AC:2005

EN 60947-5-1:2004/A1:2009

IEC 60947-5-1:2003/A1:2009

Note 3

Date expired

(1.5.2012)

Cenelec

EN 60947-5-2:2007

Low-voltage switchgear and controlgear — Part 5-2: Control circuit devices and switching elements — Proximity switches

IEC 60947-5-2:2007

EN 60947-5-2:1998

- A2:2004

Date expired

(1.11.2010)

EN 60947-5-2:2007/A1:2012

IEC 60947-5-2:2007/A1:2012

Note 3

Date expired

(1.11.2015)

Cenelec

EN 60947-5-3:1999

Low-voltage switchgear and controlgear — Part 5-3: Control circuit devices and switching elements — Requirements for proximity devices with defined behaviour under fault conditions (PDF)

IEC 60947-5-3:1999

Relevant generic standard(s)

Note 2.1

Date expired

(1.5.2002)

EN 60947-5-3:1999/A1:2005

IEC 60947-5-3:1999/A1:2005

Note 3

Date expired

(1.3.2008)

Cenelec

EN 60947-5-6:2000

Low-voltage switchgear and controlgear — Part 5-6: Control circuit devices and switching elements — DC interface for proximity sensors and switching amplifiers (NAMUR)

IEC 60947-5-6:1999

EN 50227:1997

Note 2.1

Date expired

(1.1.2003)

Cenelec

EN 60947-5-7:2003

Low-voltage switchgear and controlgear — Part 5-7: Control circuit devices and switching elements — Requirements for proximity devices with analogue output

IEC 60947-5-7:2003

Relevant generic standard(s)

Note 2.1

Date expired

(1.9.2006)

Cenelec

EN 60947-5-9:2007

Low-voltage switchgear and controlgear — Part 5-9: Control circuit devices and switching elements — Flow rate switches

IEC 60947-5-9:2006

Cenelec

EN 60947-6-1:2005

Low-voltage switchgear and controlgear — Part 6-1: Multiple function equipment — Transfer switching equipment

IEC 60947-6-1:2005

EN 60947-6-1:1991

- A2:1997

Note 2.1

Date expired

(1.10.2008)

EN 60947-6-1:2005/A1:2014

IEC 60947-6-1:2005/A1:2013

Note 3

Date expired

(17.1.2017)

Cenelec

EN 60947-6-2:2003

Low-voltage switchgear and controlgear — Part 6-2: Multiple function equipment — Control and protective switching devices (or equipment) (CPS)

IEC 60947-6-2:2002

EN 60947-6-2:1993

- A1:1997

Note 2.1

Date expired

(1.9.2005)

EN 60947-6-2:2003/A1:2007

IEC 60947-6-2:2002/A1:2007

Note 3

Date expired

(1.3.2010)

Cenelec

EN 60947-8:2003

Low-voltage switchgear and controlgear — Part 8: Control units for built-in thermal protection (PTC) for rotating electrical machines

IEC 60947-8:2003

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2006)

EN 60947-8:2003/A1:2006

IEC 60947-8:2003/A1:2006

Note 3

Date expired

(1.10.2009)

EN 60947-8:2003/A2:2012

IEC 60947-8:2003/A2:2011

Note 3

Date expired

(22.6.2014)

Cenelec

EN 60974-10:2007

Arc welding equipment — Part 10: Electromagnetic compatibility (EMC) requirements

IEC 60974-10:2007

EN 60974-10:2003

Note 2.1

Date expired

(1.12.2010)

Cenelec

EN 60974-10:2014

Arc welding equipment — Part 10: Electromagnetic compatibility (EMC) requirements

IEC 60974-10:2014

EN 60974-10:2007

Note 2.1

Date expired

(13.3.2017)

Cenelec

EN 61000-3-2:2006

Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current <= 16 A per phase)

IEC 61000-3-2:2005

EN 61000-3-2:2000

- A2:2005

Note 2.1

Date expired

(1.2.2009)

EN 61000-3-2:2006/A2:2009

IEC 61000-3-2:2005/A2:2009

Note 3

Date expired

(1.7.2012)

EN 61000-3-2:2006/A1:2009

IEC 61000-3-2:2005/A1:2008

Note 3

Date expired

(1.7.2012)

Cenelec

EN 61000-3-2:2014

Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)

IEC 61000-3-2:2014

EN 61000-3-2:2006

Note 2.1

Date expired

(30.6.2017)

Cenelec

EN 61000-3-3:2008

Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection

IEC 61000-3-3:2008

EN 61000-3-3:1995

Date expired

(1.9.2011)

Cenelec

EN 61000-3-3:2013

Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection

IEC 61000-3-3:2013

EN 61000-3-3:2008

Note 2.1

Date expired

(18.6.2016)

Cenelec

EN 61000-3-11:2000

Electromagnetic compatibility (EMC) — Part 3-11: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems — Equipment with rated current <= 75 A and subject to conditional connection

IEC 61000-3-11:2000

Relevant generic standard(s)

Note 2.3

Date expired

(1.11.2003)

Cenelec

EN 61000-3-12:2011

Electromagnetic compatibility (EMC) — Part 3-12: Limits — Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and <= 75 A per phase

IEC 61000-3-12:2011

IEC 61000-3-12:2011/IS1:2012

EN 61000-3-12:2005

Note 2.1

Date expired

(16.6.2014)

Cenelec

EN 61000-6-1:2007

Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments

IEC 61000-6-1:2005

EN 61000-6-1:2001

Note 2.1

Date expired

(1.12.2009)

Cenelec

EN 61000-6-2:2005

Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity for industrial environments

IEC 61000-6-2:2005

EN 61000-6-2:2001

Note 2.1

Date expired

(1.6.2008)

EN 61000-6-2:2005/AC:2005

Cenelec

EN 61000-6-3:2007

Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments

IEC 61000-6-3:2006

EN 61000-6-3:2001

- A11:2004

Date expired

(1.12.2009)

EN 61000-6-3:2007/A1:2011

IEC 61000-6-3:2006/A1:2010

Note 3

Date expired

(12.1.2014)

EN 61000-6-3:2007/A1:2011/AC:2012

Cenelec

EN 61000-6-4:2007

Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments

IEC 61000-6-4:2006

EN 61000-6-4:2001

Note 2.1

Date expired

(1.12.2009)

EN 61000-6-4:2007/A1:2011

IEC 61000-6-4:2006/A1:2010

Note 3

Date expired

(12.1.2014)

Cenelec

EN 61008-1:2004

Residual current operated circuit-breakers without integral overcurrent protection for household and similar uses (RCCB's) — Part 1: General rules

IEC 61008-1:1996 (Modified)

IEC 61008-1:1996/A1:2002 (Modified)

EN 61008-1:1994

- A2:1995

- A14:1998

Date expired

(1.4.2009)

EN 61008-1:2004/A12:2009

Note 3

Date expired

(1.12.2011)

Cenelec

EN 61008-1:2012

Residual current operated circuit-breakers without integral overcurrent protection for household and similar uses (RCCBs) — Part 1: General rules

IEC 61008-1:2010 (Modified)

EN 61008-1:2004

and its amendment

Date expired

(18.6.2017)

Cenelec

EN 61009-1:2004

Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBO's) — Part 1: General rules

IEC 61

IEC 61009-1:1996 (Modified)

IEC 61009-1:1996/A1:2002 (Modified)

EN 61009-1:1994

- A1:1995

- A14:1998

Date expired

(1.4.2009)

EN 61009-1:2004/AC:2006

EN 61009-1:2004/A12:2009

Note 3

Date expired

(1.12.2011)

EN 61009-1:2004/A13:2009

Note 3

Date expired

(1.12.2011)

Cenelec

EN 61009-1:2012

Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBOs) — Part 1: General rules

IEC 61009-1:2010 (Modified)

EN 61009-1:2004

and its amendments

Date expired

(18.6.2017)

Cenelec

EN 61131-2:2007

Programmable controllers — Part 2: Equipment requirements and tests

IEC 61131-2:2007

EN 61131-2:2003

Note 2.1

Date expired

(1.8.2010)

Cenelec

EN 61204-3:2000

Low voltage power supplies, d.c. output — Part 3: Electromagnetic compatibility (EMC)

IEC 61204-3:2000

Relevant generic standard(s)

Note 2.3

Date expired

(1.11.2003)

Cenelec

EN 61326-1:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements

IEC 61326-1:2005

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.2.2009)

Cenelec

EN 61326-1:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements

IEC 61326-1:2012

EN 61326-1:2006

Note 2.1

Date expired

(14.8.2015)

Cenelec

EN 61326-2-1:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-1: Particular requirements — Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications

IEC 61326-2-1:2005

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.2.2009)

Cenelec

EN 61326-2-1:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-1: Particular requirements — Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications

IEC 61326-2-1:2012

EN 61326-2-1:2006

Note 2.1

Date expired

(6.11.2015)

Cenelec

EN 61326-2-2:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-2: Particular requirements — Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems

IEC 61326-2-2:2005

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.2.2009)

Cenelec

EN 61326-2-2:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-2: Particular requirements — Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems

IEC 61326-2-2:2012

EN 61326-2-2:2006

Note 2.1

Date expired

(6.11.2015)

Cenelec

EN 61326-2-3:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-3: Particular requirements — Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning

IEC 61326-2-3:2006

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.8.2009)

Cenelec

EN 61326-2-3:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-3: Particular requirements — Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning

IEC 61326-2-3:2012

EN 61326-2-3:2006

Note 2.1

Date expired

(14.8.2015)

Cenelec

EN 61326-2-4:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-4: Particular requirements — Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9

IEC 6132

IEC 61326-2-4:2006

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.11.2009)

Cenelec

EN 61326-2-4:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-4: Particular requirements — Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9

IEC 61326-2-4:2012

EN 61326-2-4:2006

Note 2.1

Date expired

(14.8.2015)

Cenelec

EN 61326-2-5:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-5: Particular requirements — Test configurations, operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1, CP 3/2

IEC 61326-2-5:2006

EN 61326:1997

- A1:1998

- A2:2001

- A3:2003

Note 2.1

Date expired

(1.9.2009)

Cenelec

EN 61326-2-5:2013

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-5: Particular requirements — Test configurations, operational conditions and performance criteria for devices with field bus interfaces according to IEC 61784-1

IEC 61326-2-5:2012

EN 61326-2-5:2006

Note 2.1

Date expired

(6.11.2015)

Cenelec

EN 61439-1:2011

Low-voltage switchgear and controlgear assemblies — Part 1: General rules

IEC 61439-1:2011

EN 61439-1:2009

Note 2.1

Date expired

(23.9.2014)

Cenelec

EN 61439-1:2009

Low-voltage switchgear and controlgear assemblies — Part 1: General rules

IEC 61439-1:2009 (Modified)

EN 60439-1:1999

Note 2.1

Date expired

(1.11.2014)

EN 61439-1:2009/AC:2013

EN 61439-1:2009 does not give presumption of conformity without another part of the standard.

Cenelec

EN 61439-2:2011

Low-voltage switchgear and controlgear assemblies — Part 2: Power switchgear and controlgear assemblies

IEC 61439-2:2011

EN 61439-2:2009

Note 2.1

Date expired

(23.9.2014)

Cenelec

EN 61439-2:2009

Low-voltage switchgear and controlgear assemblies — Part 2: Power switchgear and controlgear assemblies

IEC 61439-2:2009

Cenelec

EN 61439-3:2012

Low-voltage switchgear and controlgear assemblies — Part 3: Distribution boards intended to be operated by ordinary persons (DBO)

IEC 61439-3:2012

Cenelec

EN 61439-4:2013

Low-voltage switchgear and controlgear assemblies — Part 4: Particular requirements for assemblies for construction sites (ACS)

IEC 61439-4:2012

Cenelec

EN 61439-5:2011

Low-voltage switchgear and controlgear assemblies — Part 5: Assemblies for power distribution in public networks

IEC 61439-5:2010

Cenelec

EN 61439-6:2012

Low-voltage switchgear and controlgear assemblies — Part 6: Busbar trunking systems (busways)

IEC 61439-6:2012

Cenelec

EN 61543:1995

Residual current-operated protective devices (RCDs) for household and similar use — Electromagnetic compatibility

IEC 61543:1995

Relevant generic standard(s)

Note 2.3

Date expired

(4.7.1998)

EN 61543:1995/AC:1997

EN 61543:1995/A11:2003/AC:2004

EN 61543:1995/A11:2003

IEC 61543:1995/A1:2004

Note 3

Date expired

(1.3.2007)

EN 61543:1995/A12:2005

Note 3

Date expired

(1.3.2008)

EN 61543:1995/A2:2006

IEC 61543:1995/A2:2005

Note 3

Date expired

(1.12.2008)

Cenelec

EN 61547:2009

Equipment for general lighting purposes — EMC immunity requirements

IEC 61547:2009

IEC 61547:2009/IS1:2013

EN 61547:1995

Date expired

(1.7.2012)

Cenelec

EN 61557-12:2008

Electrical safety in low voltage distribution systems up to 1  000 V a.c. and 1  500 V d.c. — Equipment for testing, measuring or monitoring of protective measures — Part 12: Performance measuring and monitoring devices (PMD)

IEC 61557-12:2007

Cenelec

EN 61800-3:2004

Adjustable speed electrical power drive systems — Part 3: EMC requirements and specific test methods

IEC 61800-3:2004

EN 61800-3:1996

- A11:2000

Note 2.1

Date expired

(1.10.2007)

EN 61800-3:2004/A1:2012

IEC 61800-3:2004/A1:2011

Note 3

Date expired

(19.12.2014)

Cenelec

EN 61812-1:2011

Time relays for industrial and residential use — Part 1: Requirements and tests

IEC 61812-1:2011

EN 61812-1:1996

Note 2.1

Date expired

(29.6.2014)

Cenelec

EN 62020:1998

Electrical accessories — Residual current monitors for household and similar uses (RCMs)

IEC 62020:1998

EN 62020:1998/A1:2005

IEC 62020:1998/A1:2003 (Modified)

Note 3

Date expired

(1.3.2008)

Cenelec

EN 62026-1:2007

Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 1: General rules

IEC 62026-1:2007

Relevant generic standard(s)

Note 2.1

Date expired

(1.9.2010)

EN 62026-1:2007 does not give presumption of conformity without another part of the standard.

Cenelec

EN 62026-2:2013

Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 2: Actuator sensor interface (AS-i)

IEC 62026-2:2008 (Modified)

EN 50295:1999

Note 2.1

Date expired

(3.12.2015)

Cenelec

EN 62026-3:2009

Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 3: DeviceNet

IEC 62026-3:2008

Relevant generic standard(s)

Note 2.1

Date expired

(1.5.2012)

Cenelec

EN 62026-7:2013

Low-voltage switchgear and controlgear — Controller-device interfaces (CDIs) — Part 7: CompoNet

IEC 62026-7:2010 (Modified)

Cenelec

EN 62040-2:2006

Uninterruptible power systems (UPS) — Part 2: Electromagnetic compatibility (EMC) requirements

IEC 62

IEC 62040-2:2005

EN 50091-2:1995

Note 2.1

Date expired

(1.10.2008)

EN 62040-2:2006/AC:2006

Cenelec

EN 62052-11:2003

Electricity metering equipment (AC) — General requirements, tests and test conditions — Part 11: Metering equipment

IEC 62052-11:2003

Relevant generic standard(s)

Note 2.3

Date expired

(1.3.2006)

EN 62052-11:2003 does not give presumption of conformity without a part of the EN 62053 series.

Cenelec

EN 62052-21:2004

Electricity metering equipment (a.c.) — General requirements, tests and test conditions — Part 21: Tariff and load control equipment

IEC 62052-21:2004

EN 61037:1992

- A1:1996

- A2:1998

- EN 61038:1992

- A1:1996

- A2:1998

Note 2.1

Date expired

(1.7.2007)

EN 62052-21:2004 does not give presumption of conformity without a part of the EN 62054 series.

Cenelec

EN 62053-11:2003

Electricity metering equipment (a.c.) — Particular requirements — Part 11: Electromechanical meters for active energy (classes 0,5, 1 and 2)

IEC 62053-11:2003

EN 60521:1995

Note 2.1

Date expired

(1.3.2006)

Cenelec

EN 62053-21:2003

Electricity metering equipment (a.c.) — Particular requirements — Part 21: Static meters for active energy (classes 1 and 2)

IEC 62053-21:2003

EN 61036:1996

- A1:2000

Note 2.1

Date expired

(1.3.2006)

Cenelec

EN 62053-22:2003

Electricity metering equipment (a.c.) — Particular requirements — Part 22: Static meters for active energy (classes 0,2 S and 0,5 S)

IEC 62053-22:2003

EN 60687:1992

Note 2.1

Date expired

(1.3.2006)

Cenelec

EN 62053-23:2003

Electricity metering equipment (a.c.) — Particular requirements — Part 23: Static meters for reactive energy (classes 2 and 3)

IEC 62053-23:2003

EN 61268:1996

Note 2.1

Date expired

(1.3.2006)

Cenelec

EN 62054-11:2004

Electricity metering (a.c.) — Tariff and load control — Part 11: Particular requirements for electronic ripple control receivers

IEC 62054-11:2004

EN 61037:1992

- A1:1996

- A2:1998

Note 2.1

Date expired

(1.7.2007)

Cenelec

EN 62054-21:2004

Electricity metering (a.c.) — Tariff and load control — Part 21: Particular requirements for time switches

IEC 62054-21:2004

EN 61038:1992

- A1:1996

- A2:1998

Note 2.1

Date expired

(1.7.2007)

Cenelec

EN 62135-2:2008

Resistance welding equipment — Part 2: Electromagnetic compatibility (EMC) requirements

IEC 62135-2:2007

EN 50240:2004

Note 2.1

Date expired

(1.2.2011)

Cenelec

EN 62310-2:2007

Static transfer systems (STS) — Part 2: Electromagnetic compatibility (EMC) requirements

IEC 62310-2:2006 (Modified)

Relevant generic standard(s)

Note 2.1

Date expired

(1.9.2009)

Cenelec

EN 62423:2009

Type B residual current operated circuit-breakers with and without integral overcurrent protection for household and similar uses (Type B RCCBs and Type B RCBOs)

IEC 62423:2007 (Modified)

Cenelec

EN 62423:2012

Type F and type B residual current operated circuit-breakers with and without integral overcurrent protection for household and similar uses

IEC

IEC 62423:2009 (Modified)

EN 62423:2009

Note 2.1

Date expired

(19.6.2017)

Cenelec

EN 62586-1:2014

Power quality measurement in power supply systems — Part 1: Power quality instruments (PQI)

IEC 62586-1:2013

Cenelec

EN 62586-2:2014

Power quality measurement in power supply systems — Part 2: Functional tests and uncertainty requirements

IEC 62586-2:2013

Cenelec

EN 62606:2013

General requirements for arc fault detection devices

IEC

IEC 62606:2013 (Modified)

ETSI

EN 300 386 V1.4.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements

EN 300 386 V1.3.3

Note 2.1

Date expired

(31.7.2011)

ETSI

EN 300 386 V1.5.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements

EN 300 386 V1.4.1

Note 2.1

Date expired

(31.1.2014)

ETSI

EN 300 386 V1.6.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); Telecommunication network equipment; ElectroMagnetic Compatibility (EMC) requirements

EN 300 386 V1.5.1

Note 2.1

Date expired

(30.11.2015)

ETSI

EN 301 489-1 V1.9.2

Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements

EN 301 489-1 V1.8.1

Note 2.1

Date expired

(30.6.2013)

ETSI

EN 301 489-34 V1.1.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones

ETSI

EN 301 489-34 V1.3.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones

EN 301 489-34 V1.1.1

Note 2.1

Date expired

(28.2.2014)

ETSI

EN 301 489-34 V1.4.1

Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 34: Specific conditions for External Power Supply (EPS) for mobile phones

EN 301 489-34 V1.3.1

Note 2.1

Date expired

(28.2.2015)

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
| --- | --- |

—

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

---

| 16.1.2015 | EN | Official Journal of the European Union | C 14/22 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/22

---

Commission communication in the framework of the implementation of the Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 014/02)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) |
| CEN | EN ISO 6185-1:2001
  Inflatable boats — Part 1: Boats with a maximum motor power rating of 4,5 kW (ISO 6185-1:2001) | 17.4.2002 | | |
| CEN | EN ISO 6185-2:2001
  Inflatable boats — Part 2: Boats with a maximum motor power rating of 4,5 kW to 15 kW inclusive (ISO 6185-2:2001) | 17.4.2002 | | |
| CEN | EN ISO 6185-3:2014
  Inflatable boats — Part 3: Boats with a hull length less than 8 m with a motor rating of 15 kW and greater (ISO 6185-3:2014) | This is the first publication | EN ISO 6185-3:2001
  Note 2.1 | Date expired
  (31.8.2016) |
| CEN | EN ISO 6185-4:2011
  Inflatable boats — Part 4: Boats with a hull length of between 8 m and 24 m with a motor power rating of 15 kW and greater (ISO 6185-4:2011) | 4.1.2012 | | |
| CEN | EN ISO 7840:2013
  Small craft — Fire-resistant fuel hoses (ISO 7840:2013) | 18.12.2013 | EN ISO 7840:2004
  Note 2.1 | Date expired
  (24.7.2014) |
| CEN | EN ISO 8099:2000
  Small craft — Toilet waste retention systems (ISO 8099:2000) | 11.5.2001 | | |
| CEN | EN ISO 8469:2013
  Small craft — Non-fire-resistant fuel hoses (ISO 8469:2013) | 18.12.2013 | EN ISO 8469:2006
  Note 2.1 | Date expired
  (24.7.2014) |
| CEN | EN ISO 8665:2006
  Small craft — Marine propulsion reciprocating internal combustion engines — Power measurements and declarations (ISO 8665:2006) | 16.9.2006 | EN ISO 8665:1995
  Note 2.1 | Date expired
  (31.12.2006) |
| CEN | EN ISO 8666:2002
  Small craft — Principal data (ISO 8666:2002) | 20.5.2003 | | |
| CEN | EN ISO 8847:2004
  Small craft — Steering gear — Cable and pulley systems (ISO 8847:2004) | 8.1.2005 | EN 28847:1989
  Note 2.1 | Date expired
  (30.11.2004) |
| | EN ISO 8847:2004/AC:2005 | 14.3.2006 | | |
| CEN | EN ISO 8849:2003
  Small craft — Electrically operated direct-current bilge-pumps (ISO 8849:2003) | 8.1.2005 | EN 28849:1993
  Note 2.1 | Date expired
  (30.4.2004) |
| CEN | EN ISO 9093-1:1997
  Small craft — Seacocks and through-hull fittings — Part 1: Metallic (ISO 9093-1:1994) | 11.5.2001 | | |
| CEN | EN ISO 9093-2:2002
  Small craft — Seacocks and through-hull fittings — Part 2: Non-metallic (ISO 9093-2:2002) | 3.4.2003 | | |
| CEN | EN ISO 9094-1:2003
  Small craft — Fire protection — Part 1: Craft with a hull length of up to and including 15 m (ISO 9094-1:2003) | 12.7.2003 | | |
| CEN | EN ISO 9094-2:2002
  Small craft — Fire protection — Part 2: Craft with a hull length of over 15 m (ISO 9094-2:2002) | 20.5.2003 | | |
| CEN | EN ISO 9097:1994
  Small craft — Electric fans (ISO 9097:1991) | 25.2.1998 | | |
| | EN ISO 9097:1994/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| CEN | EN ISO 10087:2006
  Small craft — Craft identification — Coding system (ISO 10087:2006) | 13.5.2006 | EN ISO 10087:1996
  Note 2.1 | Date expired
  (30.9.2006) |
| CEN | EN ISO 10088:2013
  Small craft — Permanently installed fuel systems (ISO 10088:2013) | 18.12.2013 | EN ISO 10088:2009
  Note 2.1 | Date expired
  (28.8.2014) |
| CEN | EN ISO 10133:2012
  Small craft — Electrical systems — Extra-low-voltage d.c. installations (ISO 10133:2012) | 13.3.2013 | EN ISO 10133:2000
  Note 2.1 | Date expired
  (30.6.2013) |
| CEN | EN ISO 10239:2008
  Small craft — Liquefied petroleum gas (LPG) systems (ISO 10239:2008) | 30.4.2008 | EN ISO 10239:2000
  Note 2.1 | Date expired
  (31.8.2008) |
| CEN | EN ISO 10240:2004
  Small craft — Owner's manual (ISO 10240:2004) | 3.5.2005 | EN ISO 10240:1996
  Note 2.1 | Date expired
  (30.4.2005) |
| CEN | EN ISO 10592:1995
  Small craft — Hydraulic steering systems (ISO 10592:1994) | 25.2.1998 | | |
| | EN ISO 10592:1995/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| CEN | EN ISO 11105:1997
  Small craft — Ventilation of petrol engine and/or petrol tank compartments (ISO 11105:1997) | 18.12.1997 | | |
| CEN | EN ISO 11192:2005
  Small craft — Graphical symbols (ISO 11192:2005) | 14.3.2006 | | |
| CEN | EN ISO 11547:1995
  Small craft — Start-in-gear protection (ISO 11547:1994) | 18.12.1997 | | |
| | EN ISO 11547:1995/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| CEN | EN ISO 11591:2011
  Small craft, engine-driven — Field of vision from helm position (ISO 11591:2011) | 4.1.2012 | EN ISO 11591:2000
  Note 2.1 | Date expired
  (31.3.2012) |
| CEN | EN ISO 11592:2001
  Small craft less than 8 m length of hull — Determination of maximum propulsion power rating (ISO 11592:2001) | 6.3.2002 | | |
| CEN | EN ISO 11812:2001
  Small craft — Watertight cockpits and quick-draining cockpits (ISO 11812:2001) | 17.4.2002 | | |
| CEN | EN ISO 12215-1:2000
  Small craft — Hull construction and scantlings — Part 1: Materials: Thermosetting resins, glass-fibre reinforcement, reference laminate (ISO 12215-1:2000) | 11.5.2001 | | |
| CEN | EN ISO 12215-2:2002
  Small craft — Hull construction and scantlings — Part 2: Materials: Core materials for sandwich construction, embedded materials (ISO 12215-2:2002) | 1.10.2002 | | |
| CEN | EN ISO 12215-3:2002
  Small craft — Hull construction and scantlings — Part 3: Materials: Steel, aluminium alloys, wood, other materials (ISO 12215-3:2002) | 1.10.2002 | | |
| CEN | EN ISO 12215-4:2002
  Small craft — Hull construction and scantlings — Part 4: Workshop and manufacturing (ISO 12215-4:2002) | 1.10.2002 | | |
| CEN | EN ISO 12215-5:2008
  Small craft — Hull construction and scantlings — Part 5: Design pressures for monohulls, design stresses, scantlings determination (ISO 12215-5:2008) | 3.12.2008 | | |
| | EN ISO 12215-5:2008/A1:2014 | This is the first publication | Note 3 | Date expired
  (28.2.2015) |
| CEN | EN ISO 12215-6:2008
  Small craft — Hull construction and scantlings — Part 6: Structural arrangements and details (ISO 12215-6:2008) | 3.12.2008 | | |
| CEN | EN ISO 12215-8:2009
  Small craft — Hull construction and scantlings — Part 8: Rudders (ISO 12215-8:2009) | 17.4.2010 | | |
| | EN ISO 12215-8:2009/AC:2010 | 11.11.2010 | | |
| CEN | EN ISO 12215-9:2012
  Small craft — Hull construction and scantlings — Part 9: Sailing craft appendages (ISO 12215-9:2012) | 15.8.2012 | | |
| CEN | EN ISO 12216:2002
  Small craft — Windows, portlights, hatches, deadlights and doors — Strength and watertightness requirements (ISO 12216:2002) | 19.12.2002 | | |
| CEN | EN ISO 12217-1:2013
  Small craft — Stability and buoyancy assessment and categorization — Part 1: Non-sailing boats of hull length greater than or equal to 6 m (ISO 12217-1:2013) | 18.12.2013 | EN ISO 12217-1:2002
  Note 2.1 | Date expired
  (6.7.2015) |
| CEN | EN ISO 12217-2:2013
  Small craft — Stability and buoyancy assessment and categorization — Part 2: Sailing boats of hull length greater than or equal to 6 m (ISO 12217-2:2013) | 14.3.2014 | EN ISO 12217-2:2002
  Note 2.1 | Date expired
  (6.7.2015) |
| CEN | EN ISO 12217-3:2013
  Small craft — Stability and buoyancy assessment and categorization — Part 3: Boats of hull length less than 6 m (ISO 12217-3:2013) | 18.12.2013 | EN ISO 12217-3:2002
  Note 2.1 | Date expired
  (6.7.2015) |
| CEN | EN ISO 13297:2012
  Small craft — Electrical systems — Alternating current installations (ISO 13297:2012) | 13.3.2013 | EN ISO 13297:2000
  Note 2.1 | Date expired
  (31.5.2013) |
| CEN | EN ISO 13590:2003
  Small craft — Personal watercraft — Construction and system installation requirements (ISO 13590:2003) | 8.1.2005 | | |
| | EN ISO 13590:2003/AC:2004 | 3.5.2005 | | |
| CEN | EN ISO 13929:2001
  Small craft — Steering gear — Geared link systems (ISO 13929:2001) | 6.3.2002 | | |
| CEN | EN ISO 14509-1:2008
  Small craft — Airborne sound emitted by powered recreational craft — Part 1: Pass-by measurement procedures (ISO 14509-1:2008) | 4.3.2009 | EN ISO 14509:2000
  Note 2.1 | Date expired
  (30.4.2009) |
| CEN | EN ISO 14509-2:2006
  Small craft — Airborne sound emitted by powered recreational craft — Part 2: Sound assessment using reference craft (ISO 14509-2:2006) | 19.7.2007 | | |
| CEN | EN ISO 14509-3:2009
  Small craft — Airborne sound emitted by powered recreational craft — Part 3: Sound assessment using calculation and measurement procedures (ISO 14509-3:2009) | 17.4.2010 | | |
| CEN | EN ISO 14895:2003
  Small craft — Liquid-fuelled galley stoves (ISO 14895:2000) | 30.10.2003 | | |
| CEN | EN ISO 14945:2004
  Small craft — Builder's plate (ISO 14945:2004) | 8.1.2005 | | |
| | EN ISO 14945:2004/AC:2005 | 14.3.2006 | | |
| CEN | EN ISO 14946:2001
  Small craft — Maximum load capacity (ISO 14946:2001) | 6.3.2002 | | |
| | EN ISO 14946:2001/AC:2005 | 14.3.2006 | | |
| CEN | EN ISO 15083:2003
  Small craft — Bilge-pumping systems (ISO 15083:2003) | 30.10.2003 | | |
| CEN | EN ISO 15084:2003
  Small craft — Anchoring, mooring and towing — Strong points (ISO 15084:2003) | 12.7.2003 | | |
| CEN | EN ISO 15085:2003
  Small craft — Man-overboard prevention and recovery (ISO 15085:2003) | 30.10.2003 | | |
| | EN ISO 15085:2003/A1:2009 | 17.4.2010 | Note 3 | Date expired
  (30.11.2009) |
| CEN | EN ISO 15584:2001
  Small craft — Inboard petrol engines — Engine-mounted fuel and electrical components (ISO 15584:2001) | 6.3.2002 | | |
| CEN | EN 15609:2012
  LPG equipment and accessories — LPG propulsion systems for boats, yachts and other craft | 15.8.2012 | EN 15609:2008
  Note 2.1 | Date expired
  (30.11.2012) |
| CEN | EN ISO 15652:2005
  Small craft — Remote steering systems for inboard mini jet boats (ISO 15652:2003) | 7.9.2005 | | |
| CEN | EN ISO 16147:2002
  Small craft — Inboard diesel engines — Engine-mounted fuel and electrical components (ISO 16147:2002) | 3.4.2003 | | |
| | EN ISO 16147:2002/A1:2013 | 10.7.2013 | Note 3 | Date expired
  (31.8.2013) |
| CEN | EN ISO 16180:2013
  Small craft — Navigation lights — Installation, placement and visibility (ISO 16180:2013) | 10.7.2013 | | |
| CEN | EN ISO 21487:2012
  Small craft — Permanently installed petrol and diesel fuel tanks (ISO 21487:2012) | 13.3.2013 | EN ISO 21487:2006
  Note 2.1 | Date expired
  (31.5.2013) |
| CEN | EN ISO 25197:2012
  Small craft — Electrical/electronic control systems for steering, shift and throttle (ISO 25197:2012) | 13.3.2013 | | |
| CEN | EN 28846:1993
  Small craft — Electrical devices — Protection against ignition of surrounding flammable gases (ISO 8846:1990) | 30.9.1995 | | |
| | EN 28846:1993/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| CEN | EN 28848:1993
  Small craft — Remote steering systems (ISO 8848:1990) | 30.9.1995 | | |
| | EN 28848:1993/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| CEN | EN 29775:1993
  Small craft — Remote steering systems for single outboard motors of 15 kW to 40 kW power (ISO 9775:1990) | 30.9.1995 | | |
| | EN 29775:1993/A1:2000 | 11.5.2001 | Note 3 | Date expired
  (31.3.2001) |
| Cenelec | EN 60092-507:2000
  Electrical installations in ships — Part 507: Pleasure craft
  IEC 60092-507:2000 | 12.6.2003 | | |

ESO (1)

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

(5)

CEN

EN ISO 6185-1:2001

Inflatable boats — Part 1: Boats with a maximum motor power rating of 4,5 kW (ISO 6185-1:2001)

17.4.2002

CEN

EN ISO 6185-2:2001

Inflatable boats — Part 2: Boats with a maximum motor power rating of 4,5 kW to 15 kW inclusive (ISO 6185-2:2001)

17.4.2002

CEN

EN ISO 6185-3:2014

Inflatable boats — Part 3: Boats with a hull length less than 8 m with a motor rating of 15 kW and greater (ISO 6185-3:2014)

This is the first publication

EN ISO 6185-3:2001

Note 2.1

Date expired

(31.8.2016)

CEN

EN ISO 6185-4:2011

Inflatable boats — Part 4: Boats with a hull length of between 8 m and 24 m with a motor power rating of 15 kW and greater (ISO 6185-4:2011)

4.1.2012

CEN

EN ISO 7840:2013

Small craft — Fire-resistant fuel hoses (ISO 7840:2013)

18.12.2013

EN ISO 7840:2004

Note 2.1

Date expired

(24.7.2014)

CEN

EN ISO 8099:2000

Small craft — Toilet waste retention systems (ISO 8099:2000)

11.5.2001

CEN

EN ISO 8469:2013

Small craft — Non-fire-resistant fuel hoses (ISO 8469:2013)

18.12.2013

EN ISO 8469:2006

Note 2.1

Date expired

(24.7.2014)

CEN

EN ISO 8665:2006

Small craft — Marine propulsion reciprocating internal combustion engines — Power measurements and declarations (ISO 8665:2006)

16.9.2006

EN ISO 8665:1995

Note 2.1

Date expired

(31.12.2006)

CEN

EN ISO 8666:2002

Small craft — Principal data (ISO 8666:2002)

20.5.2003

CEN

EN ISO 8847:2004

Small craft — Steering gear — Cable and pulley systems (ISO 8847:2004)

8.1.2005

EN 28847:1989

Note 2.1

Date expired

(30.11.2004)

EN ISO 8847:2004/AC:2005

14.3.2006

CEN

EN ISO 8849:2003

Small craft — Electrically operated direct-current bilge-pumps (ISO 8849:2003)

8.1.2005

EN 28849:1993

Note 2.1

Date expired

(30.4.2004)

CEN

EN ISO 9093-1:1997

Small craft — Seacocks and through-hull fittings — Part 1: Metallic (ISO 9093-1:1994)

11.5.2001

CEN

EN ISO 9093-2:2002

Small craft — Seacocks and through-hull fittings — Part 2: Non-metallic (ISO 9093-2:2002)

3.4.2003

CEN

EN ISO 9094-1:2003

Small craft — Fire protection — Part 1: Craft with a hull length of up to and including 15 m (ISO 9094-1:2003)

12.7.2003

CEN

EN ISO 9094-2:2002

Small craft — Fire protection — Part 2: Craft with a hull length of over 15 m (ISO 9094-2:2002)

20.5.2003

CEN

EN ISO 9097:1994

Small craft — Electric fans (ISO 9097:1991)

25.2.1998

EN ISO 9097:1994/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

CEN

EN ISO 10087:2006

Small craft — Craft identification — Coding system (ISO 10087:2006)

13.5.2006

EN ISO 10087:1996

Note 2.1

Date expired

(30.9.2006)

CEN

EN ISO 10088:2013

Small craft — Permanently installed fuel systems (ISO 10088:2013)

18.12.2013

EN ISO 10088:2009

Note 2.1

Date expired

(28.8.2014)

CEN

EN ISO 10133:2012

Small craft — Electrical systems — Extra-low-voltage d.c. installations (ISO 10133:2012)

13.3.2013

EN ISO 10133:2000

Note 2.1

Date expired

(30.6.2013)

CEN

EN ISO 10239:2008

Small craft — Liquefied petroleum gas (LPG) systems (ISO 10239:2008)

30.4.2008

EN ISO 10239:2000

Note 2.1

Date expired

(31.8.2008)

CEN

EN ISO 10240:2004

Small craft — Owner's manual (ISO 10240:2004)

3.5.2005

EN ISO 10240:1996

Note 2.1

Date expired

(30.4.2005)

CEN

EN ISO 10592:1995

Small craft — Hydraulic steering systems (ISO 10592:1994)

25.2.1998

EN ISO 10592:1995/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

CEN

EN ISO 11105:1997

Small craft — Ventilation of petrol engine and/or petrol tank compartments (ISO 11105:1997)

18.12.1997

CEN

EN ISO 11192:2005

Small craft — Graphical symbols (ISO 11192:2005)

14.3.2006

CEN

EN ISO 11547:1995

Small craft — Start-in-gear protection (ISO 11547:1994)

18.12.1997

EN ISO 11547:1995/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

CEN

EN ISO 11591:2011

Small craft, engine-driven — Field of vision from helm position (ISO 11591:2011)

4.1.2012

EN ISO 11591:2000

Note 2.1

Date expired

(31.3.2012)

CEN

EN ISO 11592:2001

Small craft less than 8 m length of hull — Determination of maximum propulsion power rating (ISO 11592:2001)

6.3.2002

CEN

EN ISO 11812:2001

Small craft — Watertight cockpits and quick-draining cockpits (ISO 11812:2001)

17.4.2002

CEN

EN ISO 12215-1:2000

Small craft — Hull construction and scantlings — Part 1: Materials: Thermosetting resins, glass-fibre reinforcement, reference laminate (ISO 12215-1:2000)

11.5.2001

CEN

EN ISO 12215-2:2002

Small craft — Hull construction and scantlings — Part 2: Materials: Core materials for sandwich construction, embedded materials (ISO 12215-2:2002)

1.10.2002

CEN

EN ISO 12215-3:2002

Small craft — Hull construction and scantlings — Part 3: Materials: Steel, aluminium alloys, wood, other materials (ISO 12215-3:2002)

1.10.2002

CEN

EN ISO 12215-4:2002

Small craft — Hull construction and scantlings — Part 4: Workshop and manufacturing (ISO 12215-4:2002)

1.10.2002

CEN

EN ISO 12215-5:2008

Small craft — Hull construction and scantlings — Part 5: Design pressures for monohulls, design stresses, scantlings determination (ISO 12215-5:2008)

3.12.2008

EN ISO 12215-5:2008/A1:2014

This is the first publication

Note 3

Date expired

(28.2.2015)

CEN

EN ISO 12215-6:2008

Small craft — Hull construction and scantlings — Part 6: Structural arrangements and details (ISO 12215-6:2008)

3.12.2008

CEN

EN ISO 12215-8:2009

Small craft — Hull construction and scantlings — Part 8: Rudders (ISO 12215-8:2009)

17.4.2010

EN ISO 12215-8:2009/AC:2010

11.11.2010

CEN

EN ISO 12215-9:2012

Small craft — Hull construction and scantlings — Part 9: Sailing craft appendages (ISO 12215-9:2012)

15.8.2012

CEN

EN ISO 12216:2002

Small craft — Windows, portlights, hatches, deadlights and doors — Strength and watertightness requirements (ISO 12216:2002)

19.12.2002

CEN

EN ISO 12217-1:2013

Small craft — Stability and buoyancy assessment and categorization — Part 1: Non-sailing boats of hull length greater than or equal to 6 m (ISO 12217-1:2013)

18.12.2013

EN ISO 12217-1:2002

Note 2.1

Date expired

(6.7.2015)

CEN

EN ISO 12217-2:2013

Small craft — Stability and buoyancy assessment and categorization — Part 2: Sailing boats of hull length greater than or equal to 6 m (ISO 12217-2:2013)

14.3.2014

EN ISO 12217-2:2002

Note 2.1

Date expired

(6.7.2015)

CEN

EN ISO 12217-3:2013

Small craft — Stability and buoyancy assessment and categorization — Part 3: Boats of hull length less than 6 m (ISO 12217-3:2013)

18.12.2013

EN ISO 12217-3:2002

Note 2.1

Date expired

(6.7.2015)

CEN

EN ISO 13297:2012

Small craft — Electrical systems — Alternating current installations (ISO 13297:2012)

13.3.2013

EN ISO 13297:2000

Note 2.1

Date expired

(31.5.2013)

CEN

EN ISO 13590:2003

Small craft — Personal watercraft — Construction and system installation requirements (ISO 13590:2003)

8.1.2005

EN ISO 13590:2003/AC:2004

3.5.2005

CEN

EN ISO 13929:2001

Small craft — Steering gear — Geared link systems (ISO 13929:2001)

6.3.2002

CEN

EN ISO 14509-1:2008

Small craft — Airborne sound emitted by powered recreational craft — Part 1: Pass-by measurement procedures (ISO 14509-1:2008)

4.3.2009

EN ISO 14509:2000

Note 2.1

Date expired

(30.4.2009)

CEN

EN ISO 14509-2:2006

Small craft — Airborne sound emitted by powered recreational craft — Part 2: Sound assessment using reference craft (ISO 14509-2:2006)

19.7.2007

CEN

EN ISO 14509-3:2009

Small craft — Airborne sound emitted by powered recreational craft — Part 3: Sound assessment using calculation and measurement procedures (ISO 14509-3:2009)

17.4.2010

CEN

EN ISO 14895:2003

Small craft — Liquid-fuelled galley stoves (ISO 14895:2000)

30.10.2003

CEN

EN ISO 14945:2004

Small craft — Builder's plate (ISO 14945:2004)

8.1.2005

EN ISO 14945:2004/AC:2005

14.3.2006

CEN

EN ISO 14946:2001

Small craft — Maximum load capacity (ISO 14946:2001)

6.3.2002

EN ISO 14946:2001/AC:2005

14.3.2006

CEN

EN ISO 15083:2003

Small craft — Bilge-pumping systems (ISO 15083:2003)

30.10.2003

CEN

EN ISO 15084:2003

Small craft — Anchoring, mooring and towing — Strong points (ISO 15084:2003)

12.7.2003

CEN

EN ISO 15085:2003

Small craft — Man-overboard prevention and recovery (ISO 15085:2003)

30.10.2003

EN ISO 15085:2003/A1:2009

17.4.2010

Note 3

Date expired

(30.11.2009)

CEN

EN ISO 15584:2001

Small craft — Inboard petrol engines — Engine-mounted fuel and electrical components (ISO 15584:2001)

6.3.2002

CEN

EN 15609:2012

LPG equipment and accessories — LPG propulsion systems for boats, yachts and other craft

15.8.2012

EN 15609:2008

Note 2.1

Date expired

(30.11.2012)

CEN

EN ISO 15652:2005

Small craft — Remote steering systems for inboard mini jet boats (ISO 15652:2003)

7.9.2005

CEN

EN ISO 16147:2002

Small craft — Inboard diesel engines — Engine-mounted fuel and electrical components (ISO 16147:2002)

3.4.2003

EN ISO 16147:2002/A1:2013

10.7.2013

Note 3

Date expired

(31.8.2013)

CEN

EN ISO 16180:2013

Small craft — Navigation lights — Installation, placement and visibility (ISO 16180:2013)

10.7.2013

CEN

EN ISO 21487:2012

Small craft — Permanently installed petrol and diesel fuel tanks (ISO 21487:2012)

13.3.2013

EN ISO 21487:2006

Note 2.1

Date expired

(31.5.2013)

CEN

EN ISO 25197:2012

Small craft — Electrical/electronic control systems for steering, shift and throttle (ISO 25197:2012)

13.3.2013

CEN

EN 28846:1993

Small craft — Electrical devices — Protection against ignition of surrounding flammable gases (ISO 8846:1990)

30.9.1995

EN 28846:1993/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

CEN

EN 28848:1993

Small craft — Remote steering systems (ISO 8848:1990)

30.9.1995

EN 28848:1993/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

CEN

EN 29775:1993

Small craft — Remote steering systems for single outboard motors of 15 kW to 40 kW power (ISO 9775:1990)

30.9.1995

EN 29775:1993/A1:2000

11.5.2001

Note 3

Date expired

(31.3.2001)

Cenelec

EN 60092-507:2000

Electrical installations in ships — Part 507: Pleasure craft

IEC 60092-507:2000

12.6.2003

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
| --- | --- |

—

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

---

| 16.1.2015 | EN | Official Journal of the European Union | C 14/29 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/29

---

Commission communication in the framework of the implementation of the Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety

(Publication of titles and references of European standards under the directive)

(Text with EEA relevance)

(2015/C 014/03)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard |
| --- | --- | --- | --- |
| (1) | (2) | (3) | (4) |
| CEN | EN 581-1:2006
  Outdoor furniture — Seating and tables for camping, domestic and contract use — Part 1: General safety requirements | 22.7.2006 | |
| CEN | EN 913:2008
  Gymnastic equipment — General safety requirements and test methods | 11.7.2014 | EN 913:1996
  Note 2.1 |
| CEN | EN 914:2008
  Gymnastic equipment — Parallel bars and combination asymmetric/parallel bars — Requirements and test methods including safety | 11.7.2014 | |
| CEN | EN 915:2008
  Gymnastic equipment — Asymmetric bars — Requirements and test methods including safety | 11.7.2014 | |
| CEN | EN 916:2003
  Gymnastic equipment — Vaulting boxes — Requirements and test methods including safety | 15.10.2005 | |
| CEN | EN 957-2:2003
  Stationary training equipment — Part 2: Strength training equipment, additional specific safety requirements and test methods | 22.7.2006 | |
| CEN | EN 957-4:2006+A1:2010
  Stationary training equipment — Part 4: Strength training benches, additional specific safety requirements and test methods | 11.7.2014 | EN 957-4:2006
  Note 2.1 |
| CEN | EN 957-5:2009
  Stationary training equipment — Part 5: Stationary exercise bicycles and upper body crank training equipment, additional specific safety requirements and test methods | 11.7.2014 | EN 957-5:1996
  Note 2.1 |
| CEN | EN 957-6:2010+A1:2014
  Stationary training equipment — Part 6: Treadmills, additional specific safety requirements and test methods | This is the first publication | EN 957-6:2010
  Note 2.1 |
| CEN | EN 957-7:1998
  Stationary training equipment — Part 7: Rowing machines, additional specific safety requirements and test methods | 22.7.2006 | |
| CEN | EN 957-8:1998
  Stationary training equipment — Part 8: Steppers, stairclimbers and climbers — Additional specific safety requirements and test methods | 22.7.2006 | |
| CEN | EN 957-9:2003
  Stationary training equipment — Part 9: Elliptical trainers, additional specific safety requirements and test methods | 22.7.2006 | |
| CEN | EN 957-10:2005
  Stationary training equipment — Part 10: Exercise bicycles with a fixed wheel or without freewheel, additional specific safety requirements and test methods | 22.7.2006 | |
| CEN | EN 1129-1:1995
  Furniture — Foldaway beds — Safety requirements and testing — Part 1: Safety requirements | 15.10.2005 | |
| CEN | EN 1129-2:1995
  Furniture — Foldaway beds — Safety requirements and testing — Part 2: Test methods | 15.10.2005 | |
| CEN | EN 1130-1:1996
  Furniture — Cribs and cradles for domestic use — Part 1: Safety requirements | 24.4.2004 | |
| CEN | EN 1130-2:1996
  Furniture — Cribs and cradles for domestic use — Part 2: Test methods | 24.4.2004 | |
| CEN | EN 1273:2005
  Child use and care articles — Baby walking frames — Safety requirements and test methods | 17.2.2009 | |
| CEN | EN 1400-1:2002
  Child use and care articles — Soothers for babies and young children — Part 1: General safety requirements and product information | 24.4.2004 | |
| CEN | EN 1400-2:2002
  Child use and care articles — Soothers for babies and young children — Part 2: Mechanical requirements and tests | 24.4.2004 | |
| CEN | EN 1400-3:2002
  Child use and care articles — Soothers for babies and young children — Part 3: Chemical requirements and tests | 24.4.2004 | |
| CEN | EN 1466:2004
  Child care articles — Carrycots and stands — Safety requirements and test methods | 24.4.2004 | |
| CEN | EN 1651:1999
  Paragliding equipment — Harnesses — Safety requirements and strength tests | 15.10.2005 | |
| CEN | EN 1860-1:2003
  Appliances, solid fuels and firelighters for barbecueing — Part 1: Barbecues burning solid fuels — Requirements and test methods | 15.10.2005 | |
| | EN 1860-1:2003/A1:2006 | 11.7.2014 | Note 3 |
| CEN | EN ISO 9994:2006
  Lighters — Safety specification (ISO 9994:2005) | 22.7.2006 | EN ISO 9994:2002
  Note 2.1 |
| CEN | EN 12196:2003
  Gymnastic equipment — Horses and bucks — Functional and safety requirements, test methods | 15.10.2005 | |
| CEN | EN 12197:1997
  Gymnastic equipment — Horizontal bars — Safety requirements and test methods | 15.10.2005 | |
| CEN | EN 12346:1998
  Gymnastic equipment — Wall bars, lattice ladders and climbing frames — Safety requirements and test methods | 15.10.2005 | |
| CEN | EN 12432:1998
  Gymnastic equipment — Balancing beams — Functional and safety requirements, test methods | 15.10.2005 | |
| CEN | EN 12491:2001
  Paragliding equipment — Emergency parachutes — Safety requirements and test methods | 15.10.2005 | |
| CEN | EN 12586:1999
  Child care articles — Soother holder — Safety requirements and test methods | 24.4.2004 | |
| | EN 12586:1999/AC:2002 | 24.4.2004 | |
| CEN | EN 12655:1998
  Gymnastic equipment — Hanging rings — Functional and safety requirements, test methods | 15.10.2005 | |
| CEN | EN ISO 12863:2010
  Standard test method for assessing the ignition propensity of cigarettes (ISO 12863:2010) | 17.11.2011 | |
| CEN | EN 13120:2009+A1:2014
  Internal blinds — Performance requirements including safety | 10.10.2014 | |
| CEN | EN 13138-2:2002
  Buoyancy aids for swimming instruction — Part 2: Safety requirements and test methods for buoyancy aids to be held | 15.10.2005 | |
| CEN | EN 13209-1:2004
  Child use and care articles — Baby carriers — Safety requirements and test methods — Part 1: Framed back carriers | 22.7.2006 | |
| CEN | EN 13319:2000
  Diving accessories — Depth gauges and combined depth and time measuring devices — Functional and safety requirements, test methods | 15.10.2005 | |
| CEN | EN 13899:2003
  Roller sports equipment — Roller skates — Safety requirements and test methods | 15.10.2005 | |
| CEN | EN 14059:2002
  Decorative oil lamps — Safety requirements and test methods | 24.4.2004 | |
| CEN | EN 14344:2004
  Child use and care articles — Child seats for cycles — Safety requirements and test methods | 15.10.2005 | |
| CEN | EN 14350-1:2004
  Child use and care articles — Drinking equipment — Part 1: General and mechanical requirements and tests | 15.10.2005 | |
| CEN | EN 14682:2007
  Safety of children's clothing — Cords and drawstrings on children's clothing — Specifications | 13.4.2011 | EN 14682:2004
  Note 2.1 |
| CEN | EN 14764:2005
  City and trekking bicycles — Safety requirements and test methods | 22.7.2006 | |
| CEN | EN 14766:2005
  Mountain-bicycles — Safety requirements and test methods | 22.7.2006 | |
| CEN | EN 14781:2005
  Racing bicycles — Safety requirements and test methods | 22.7.2006 | |
| CEN | EN 14872:2006
  Bicycles — Accessories for bicycles — Luggage carriers | 22.7.2006 | |
| CEN | EN 15649-1:2009+A2:2013
  Floating leisure articles for use on and in the water — Part 1: Classification, materials, general requirements and test methods | 11.7.2014 | EN 15649-1:2009+A1:2012
  Note 2.1 |
| CEN | EN 15649-2:2009+A1:2012
  Floating leisure articles for use on and in the water — Part 2: Consumer information | 4.9.2013 | EN 15649-2:2009
  Note 2.1 |
| CEN | EN 15649-2:2009+A2:2013
  Floating leisure articles for use on and in the water — Part 2: Consumer information | This is the first publication | EN 15649-2:2009+A1:2012
  Note 2.1 |
| CEN | EN 15649-3:2009+A1:2012
  Floating leisure articles for use on and in the water — Part 3: Additional specific safety requirements and test methods for Class A devices | 4.9.2013 | EN 15649-3:2009
  Note 2.1 |
| CEN | EN 15649-4:2010+A1:2012
  Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for Class B devices | 4.9.2013 | EN 15649-4:2010
  Note 2.1 |
| CEN | EN 15649-5:2009
  Floating leisure articles for use on and in the water — Part 5: Additional specific safety requirements and test methods for Class C devices | 4.9.2013 | |
| CEN | EN 15649-6:2009+A1:2013
  Floating leisure articles for use on and in the water — Part 6: Additional specific safety requirements and test methods for Class D devices | 11.7.2014 | EN 15649-6:2009
  Note 2.1 |
| CEN | EN 15649-7:2009
  Floating leisure articles for use on and in the water — Part 7: Additional specific safety requirements and test methods for class E devices | 4.9.2013 | |
| CEN | EN 16156:2010
  Cigarettes — Assessment of the ignition propensity — Safety requirement | 17.11.2011 | |
| CEN | EN 16281:2013
  Child protective products — Consumer fitted child resistant locking devices for windows and balcony doors — Safety requirements and test methods | 11.7.2014 | |
| CEN | EN 16433:2014
  Internal blinds — Protection from strangulation hazards — Test methods | 10.10.2014 | |
| CEN | EN 16434:2014
  Internal blinds — Protection from strangulation hazards — Requirements and test methods for safety devices | 10.10.2014 | |
| CEN | EN ISO 20957-1:2013
  Stationary training equipment — Part 1: General safety requirements and test methods (ISO 20957-1:2013) | 11.7.2014 | EN 957-1:2005
  Note 2.1 |
| Cenelec | EN 60065:2002
  Audio, video and similar electronic apparatus — Safety requirements
  IEC 60065:2001 (Modified) | 4.9.2013 | |
| | EN 60065:2002/A12:2011 | 28.2.2012 | Note 3 |
| According to the Commission Implementing Decision 2012/29/EU of 13 January 2012 (OJ L 13, 17.1.2012, p. 7) the reference of standard EN 60065:2002/A12:2011 concerning protection against excessive sound pressure from personal music players shall be published. |
| Cenelec | EN 60950-1:2006
  Information technology equipment — Safety — Part 1: General requirements
  IEC 60950-1:2005 (Modified) | 4.9.2013 | |
| | EN 60950-1:2006/A12:2011 | 28.2.2012 | Note 3 |
| According to the Commission Implementing Decision 2012/29/EU of 13 January 2012 (OJ L 13, 17.1.2012, p. 7) the reference of standard EN 60950-1:2006/A12:2011 concerning protection against excessive sound pressure from personal music players shall be published. |

ESO (1)

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

(1)

(2)

(3)

(4)

CEN

EN 581-1:2006

Outdoor furniture — Seating and tables for camping, domestic and contract use — Part 1: General safety requirements

22.7.2006

CEN

EN 913:2008

Gymnastic equipment — General safety requirements and test methods

11.7.2014

EN 913:1996

Note 2.1

CEN

EN 914:2008

Gymnastic equipment — Parallel bars and combination asymmetric/parallel bars — Requirements and test methods including safety

11.7.2014

CEN

EN 915:2008

Gymnastic equipment — Asymmetric bars — Requirements and test methods including safety

11.7.2014

CEN

EN 916:2003

Gymnastic equipment — Vaulting boxes — Requirements and test methods including safety

15.10.2005

CEN

EN 957-2:2003

Stationary training equipment — Part 2: Strength training equipment, additional specific safety requirements and test methods

22.7.2006

CEN

EN 957-4:2006+A1:2010

Stationary training equipment — Part 4: Strength training benches, additional specific safety requirements and test methods

11.7.2014

EN 957-4:2006

Note 2.1

CEN

EN 957-5:2009

Stationary training equipment — Part 5: Stationary exercise bicycles and upper body crank training equipment, additional specific safety requirements and test methods

11.7.2014

EN 957-5:1996

Note 2.1

CEN

EN 957-6:2010+A1:2014

Stationary training equipment — Part 6: Treadmills, additional specific safety requirements and test methods

This is the first publication

EN 957-6:2010

Note 2.1

CEN

EN 957-7:1998

Stationary training equipment — Part 7: Rowing machines, additional specific safety requirements and test methods

22.7.2006

CEN

EN 957-8:1998

Stationary training equipment — Part 8: Steppers, stairclimbers and climbers — Additional specific safety requirements and test methods

22.7.2006

CEN

EN 957-9:2003

Stationary training equipment — Part 9: Elliptical trainers, additional specific safety requirements and test methods

22.7.2006

CEN

EN 957-10:2005

Stationary training equipment — Part 10: Exercise bicycles with a fixed wheel or without freewheel, additional specific safety requirements and test methods

22.7.2006

CEN

EN 1129-1:1995

Furniture — Foldaway beds — Safety requirements and testing — Part 1: Safety requirements

15.10.2005

CEN

EN 1129-2:1995

Furniture — Foldaway beds — Safety requirements and testing — Part 2: Test methods

15.10.2005

CEN

EN 1130-1:1996

Furniture — Cribs and cradles for domestic use — Part 1: Safety requirements

24.4.2004

CEN

EN 1130-2:1996

Furniture — Cribs and cradles for domestic use — Part 2: Test methods

24.4.2004

CEN

EN 1273:2005

Child use and care articles — Baby walking frames — Safety requirements and test methods

17.2.2009

CEN

EN 1400-1:2002

Child use and care articles — Soothers for babies and young children — Part 1: General safety requirements and product information

24.4.2004

CEN

EN 1400-2:2002

Child use and care articles — Soothers for babies and young children — Part 2: Mechanical requirements and tests

24.4.2004

CEN

EN 1400-3:2002

Child use and care articles — Soothers for babies and young children — Part 3: Chemical requirements and tests

24.4.2004

CEN

EN 1466:2004

Child care articles — Carrycots and stands — Safety requirements and test methods

24.4.2004

CEN

EN 1651:1999

Paragliding equipment — Harnesses — Safety requirements and strength tests

15.10.2005

CEN

EN 1860-1:2003

Appliances, solid fuels and firelighters for barbecueing — Part 1: Barbecues burning solid fuels — Requirements and test methods

15.10.2005

EN 1860-1:2003/A1:2006

11.7.2014

Note 3

CEN

EN ISO 9994:2006

Lighters — Safety specification (ISO 9994:2005)

22.7.2006

EN ISO 9994:2002

Note 2.1

CEN

EN 12196:2003

Gymnastic equipment — Horses and bucks — Functional and safety requirements, test methods

15.10.2005

CEN

EN 12197:1997

Gymnastic equipment — Horizontal bars — Safety requirements and test methods

15.10.2005

CEN

EN 12346:1998

Gymnastic equipment — Wall bars, lattice ladders and climbing frames — Safety requirements and test methods

15.10.2005

CEN

EN 12432:1998

Gymnastic equipment — Balancing beams — Functional and safety requirements, test methods

15.10.2005

CEN

EN 12491:2001

Paragliding equipment — Emergency parachutes — Safety requirements and test methods

15.10.2005

CEN

EN 12586:1999

Child care articles — Soother holder — Safety requirements and test methods

24.4.2004

EN 12586:1999/AC:2002

24.4.2004

CEN

EN 12655:1998

Gymnastic equipment — Hanging rings — Functional and safety requirements, test methods

15.10.2005

CEN

EN ISO 12863:2010

Standard test method for assessing the ignition propensity of cigarettes (ISO 12863:2010)

17.11.2011

CEN

EN 13120:2009+A1:2014

Internal blinds — Performance requirements including safety

10.10.2014

CEN

EN 13138-2:2002

Buoyancy aids for swimming instruction — Part 2: Safety requirements and test methods for buoyancy aids to be held

15.10.2005

CEN

EN 13209-1:2004

Child use and care articles — Baby carriers — Safety requirements and test methods — Part 1: Framed back carriers

22.7.2006

CEN

EN 13319:2000

Diving accessories — Depth gauges and combined depth and time measuring devices — Functional and safety requirements, test methods

15.10.2005

CEN

EN 13899:2003

Roller sports equipment — Roller skates — Safety requirements and test methods

15.10.2005

CEN

EN 14059:2002

Decorative oil lamps — Safety requirements and test methods

24.4.2004

CEN

EN 14344:2004

Child use and care articles — Child seats for cycles — Safety requirements and test methods

15.10.2005

CEN

EN 14350-1:2004

Child use and care articles — Drinking equipment — Part 1: General and mechanical requirements and tests

15.10.2005

CEN

EN 14682:2007

Safety of children's clothing — Cords and drawstrings on children's clothing — Specifications

13.4.2011

EN 14682:2004

Note 2.1

CEN

EN 14764:2005

City and trekking bicycles — Safety requirements and test methods

22.7.2006

CEN

EN 14766:2005

Mountain-bicycles — Safety requirements and test methods

22.7.2006

CEN

EN 14781:2005

Racing bicycles — Safety requirements and test methods

22.7.2006

CEN

EN 14872:2006

Bicycles — Accessories for bicycles — Luggage carriers

22.7.2006

CEN

EN 15649-1:2009+A2:2013

Floating leisure articles for use on and in the water — Part 1: Classification, materials, general requirements and test methods

11.7.2014

EN 15649-1:2009+A1:2012

Note 2.1

CEN

EN 15649-2:2009+A1:2012

Floating leisure articles for use on and in the water — Part 2: Consumer information

4.9.2013

EN 15649-2:2009

Note 2.1

CEN

EN 15649-2:2009+A2:2013

Floating leisure articles for use on and in the water — Part 2: Consumer information

This is the first publication

EN 15649-2:2009+A1:2012

Note 2.1

CEN

EN 15649-3:2009+A1:2012

Floating leisure articles for use on and in the water — Part 3: Additional specific safety requirements and test methods for Class A devices

4.9.2013

EN 15649-3:2009

Note 2.1

CEN

EN 15649-4:2010+A1:2012

Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for Class B devices

4.9.2013

EN 15649-4:2010

Note 2.1

CEN

EN 15649-5:2009

Floating leisure articles for use on and in the water — Part 5: Additional specific safety requirements and test methods for Class C devices

4.9.2013

CEN

EN 15649-6:2009+A1:2013

Floating leisure articles for use on and in the water — Part 6: Additional specific safety requirements and test methods for Class D devices

11.7.2014

EN 15649-6:2009

Note 2.1

CEN

EN 15649-7:2009

Floating leisure articles for use on and in the water — Part 7: Additional specific safety requirements and test methods for class E devices

4.9.2013

CEN

EN 16156:2010

Cigarettes — Assessment of the ignition propensity — Safety requirement

17.11.2011

CEN

EN 16281:2013

Child protective products — Consumer fitted child resistant locking devices for windows and balcony doors — Safety requirements and test methods

11.7.2014

CEN

EN 16433:2014

Internal blinds — Protection from strangulation hazards — Test methods

10.10.2014

CEN

EN 16434:2014

Internal blinds — Protection from strangulation hazards — Requirements and test methods for safety devices

10.10.2014

CEN

EN ISO 20957-1:2013

Stationary training equipment — Part 1: General safety requirements and test methods (ISO 20957-1:2013)

11.7.2014

EN 957-1:2005

Note 2.1

Cenelec

EN 60065:2002

Audio, video and similar electronic apparatus — Safety requirements

IEC 60065:2001 (Modified)

4.9.2013

EN 60065:2002/A12:2011

28.2.2012

Note 3

According to the Commission Implementing Decision 2012/29/EU of 13 January 2012 (OJ L 13, 17.1.2012, p. 7) the reference of standard EN 60065:2002/A12:2011 concerning protection against excessive sound pressure from personal music players shall be published.

Cenelec

EN 60950-1:2006

Information technology equipment — Safety — Part 1: General requirements

IEC 60950-1:2005 (Modified)

4.9.2013

EN 60950-1:2006/A12:2011

28.2.2012

Note 3

According to the Commission Implementing Decision 2012/29/EU of 13 January 2012 (OJ L 13, 17.1.2012, p. 7) the reference of standard EN 60950-1:2006/A12:2011 concerning protection against excessive sound pressure from personal music players shall be published.

| Note 1: | Generally, the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally, the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies, the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies, the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu) |
| --- | --- |

—

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax + 32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

---

| 16.1.2015 | EN | Official Journal of the European Union | C 14/36 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/36

---

Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 014/04)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | 31.7.2002 | EN 556:1994 + A1:1998
  Note 2.1 | Date expired
  (30.4.2002) |
| | EN 556-1:2001/AC:2006 | 15.11.2006 | | |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | 9.8.2007 | | |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN ISO 10993-1:2009
  Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | 2.12.2009 | EN ISO 10993-1:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 10993-1:2009/AC:2010 | 18.1.2011 | | |
| CEN | EN ISO 10993-4:2009
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) | 2.12.2009 | EN ISO 10993-4:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-5:2009
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | 2.12.2009 | EN ISO 10993-5:1999
  Note 2.1 | Date expired
  (31.12.2009) |
| CEN | EN ISO 10993-6:2009
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | 2.12.2009 | EN ISO 10993-6:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-7:2008
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) | 7.7.2010 | | |
| | EN ISO 10993-7:2008/AC:2009 | 7.7.2010 | | |
| CEN | EN ISO 10993-9:2009
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) | 2.12.2009 | EN ISO 10993-9:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-11:2009
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | 2.12.2009 | EN ISO 10993-11:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-12:2012
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012) | 24.1.2013 | EN ISO 10993-12:2009
  Note 2.1 | Date expired
  (31.1.2013) |
| CEN | EN ISO 10993-13:2010
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) | 18.1.2011 | EN ISO 10993-13:2009
  Note 2.1 | Date expired
  (31.12.2010) |
| CEN | EN ISO 10993-16:2010
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) | 7.7.2010 | EN ISO 10993-16:2009
  Note 2.1 | Date expired
  (31.8.2010) |
| CEN | EN ISO 10993-17:2009
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | 2.12.2009 | EN ISO 10993-17:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-18:2009
  Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) | 2.12.2009 | EN ISO 10993-18:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11135-1:2007
  Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) | 9.8.2007 | EN 550:1994
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN ISO 11137-1:2006
  Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) | 7.9.2006 | EN 552:1994
  Note 2.1 | Date expired
  (30.4.2009) |
| | EN ISO 11137-1:2006/A1:2013 | This is the first publication | Note 3 | Date expired
  (31.1.2014) |
| CEN | EN ISO 11137-2:2013
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | This is the first publication | EN ISO 11137-2:2012
  Note 2.1 | Date expired
  (31.12.2013) |
| CEN | EN ISO 11138-2:2009
  Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) | 2.12.2009 | EN ISO 11138-2:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11138-3:2009
  Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) | 2.12.2009 | EN ISO 11138-3:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11140-1:2009
  Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | 2.12.2009 | EN ISO 11140-1:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11607-1:2009
  Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | 2.12.2009 | EN ISO 11607-1:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11737-1:2006
  Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | 7.9.2006 | EN 1174-2:1996
  EN 1174-1:1996
  EN 1174-3:1996
  Note 2.1 | Date expired
  (31.10.2006) |
| | EN ISO 11737-1:2006/AC:2009 | 2.12.2009 | | |
| CEN | EN ISO 11737-2:2009
  Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) | 7.7.2010 | | |
| CEN | EN ISO 13408-1:2011
  Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| | EN ISO 13408-1:2011/A1:2013 | This is the first publication | Note 3 | Date expired
  (30.11.2013) |
| CEN | EN ISO 13408-2:2011
  Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-3:2011
  Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-4:2011
  Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-5:2011
  Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-6:2011
  Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13485:2012
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | 30.8.2012 | EN ISO 13485:2003
  Note 2.1 | Date expired
  (30.8.2012) |
| | EN ISO 13485:2012/AC:2012 | 30.8.2012 | | |
| CEN | EN ISO 14155:2011
  Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011) | 27.4.2012 | EN ISO 14155:2011
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 14937:2009
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) | 7.7.2010 | EN ISO 14937:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 14971:2012
  Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 30.8.2012 | EN ISO 14971:2009
  Note 2.1 | Date expired
  (30.8.2012) |
| CEN | EN ISO 17665-1:2006
  Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) | 15.11.2006 | EN 554:1994
  Note 2.1 | Date expired
  (31.8.2009) |
| Cenelec | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | 27.8.1998 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 45502-2-1:2003
  Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | 8.7.2004 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 45502-2-2:2008
  Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | 27.11.2008 | | |
| | EN 45502-2-2:2008/AC:2009 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 45502-2-3:2010
  Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 | 27.11.2008 | EN 60601-1:1990
  Note 2.1 | Date expired
  (1.6.2012) |
| | EN 60601-1:2006/AC:2010 | 18.1.2011 | | |
| Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
| Cenelec | EN 60601-1-6:2010
  Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
  IEC 60601-1-6:2010 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| | EN 62304:2006/AC:2008 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |

ESO (1)

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

(5)

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

31.7.2002

EN 556:1994 + A1:1998

Note 2.1

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

15.11.2006

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

9.8.2007

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

Date expired

(31.5.2010)

CEN

EN ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

2.12.2009

EN ISO 10993-1:2009

Note 2.1

Date expired

(21.3.2010)

EN ISO 10993-1:2009/AC:2010

18.1.2011

CEN

EN ISO 10993-4:2009

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

2.12.2009

EN ISO 10993-4:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

2.12.2009

EN ISO 10993-5:1999

Note 2.1

Date expired

(31.12.2009)

CEN

EN ISO 10993-6:2009

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

2.12.2009

EN ISO 10993-6:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

7.7.2010

EN ISO 10993-7:2008/AC:2009

7.7.2010

CEN

EN ISO 10993-9:2009

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

2.12.2009

EN ISO 10993-9:2009

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-11:2009

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

2.12.2009

EN ISO 10993-11:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

24.1.2013

EN ISO 10993-12:2009

Note 2.1

Date expired

(31.1.2013)

CEN

EN ISO 10993-13:2010

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

18.1.2011

EN ISO 10993-13:2009

Note 2.1

Date expired

(31.12.2010)

CEN

EN ISO 10993-16:2010

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

7.7.2010

EN ISO 10993-16:2009

Note 2.1

Date expired

(31.8.2010)

CEN

EN ISO 10993-17:2009

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

2.12.2009

EN ISO 10993-17:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-18:2009

Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)

2.12.2009

EN ISO 10993-18:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

9.8.2007

EN 550:1994

Note 2.1

Date expired

(31.5.2010)

CEN

EN ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

7.9.2006

EN 552:1994

Note 2.1

Date expired

(30.4.2009)

EN ISO 11137-1:2006/A1:2013

This is the first publication

Note 3

Date expired

(31.1.2014)

CEN

EN ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This is the first publication

EN ISO 11137-2:2012

Note 2.1

Date expired

(31.12.2013)

CEN

EN ISO 11138-2:2009

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

2.12.2009

EN ISO 11138-2:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11138-3:2009

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

2.12.2009

EN ISO 11138-3:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11140-1:2009

Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

2.12.2009

EN ISO 11140-1:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

2.12.2009

EN ISO 11607-1:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11737-1:2006

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

7.9.2006

EN 1174-2:1996

EN 1174-1:1996

EN 1174-3:1996

Note 2.1

Date expired

(31.10.2006)

EN ISO 11737-1:2006/AC:2009

2.12.2009

CEN

EN ISO 11737-2:2009

Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

7.7.2010

CEN

EN ISO 13408-1:2011

Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

EN ISO 13408-1:2011/A1:2013

This is the first publication

Note 3

Date expired

(30.11.2013)

CEN

EN ISO 13408-2:2011

Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-3:2011

Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-4:2011

Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-5:2011

Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-6:2011

Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13485:2012

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

30.8.2012

EN ISO 13485:2003

Note 2.1

Date expired

(30.8.2012)

EN ISO 13485:2012/AC:2012

30.8.2012

CEN

EN ISO 14155:2011

Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011)

27.4.2012

EN ISO 14155:2011

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 14937:2009

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

7.7.2010

EN ISO 14937:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 14971:2012

Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30.8.2012

EN ISO 14971:2009

Note 2.1

Date expired

(30.8.2012)

CEN

EN ISO 17665-1:2006

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

15.11.2006

EN 554:1994

Note 2.1

Date expired

(31.8.2009)

Cenelec

EN 45502-1:1997

Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer

27.8.1998

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 45502-2-1:2003

Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

8.7.2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 45502-2-2:2008

Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

27.11.2008

EN 45502-2-2:2008/AC:2009

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 45502-2-3:2010

Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1:2006

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005

27.11.2008

EN 60601-1:1990

Note 2.1

Date expired

(1.6.2012)

EN 60601-1:2006/AC:2010

18.1.2011

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.

Cenelec

EN 60601-1-6:2010

Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability

IEC 60601-1-6:2010

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

IEC 62304:2006

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu) |
| --- | --- |

—

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

---

| 16.1.2015 | EN | Official Journal of the European Union | C 14/43 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/43

---

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 014/05)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) |
| CEN | EN 285:2006+A2:2009
  Sterilization — Steam sterilizers — Large sterilizers | 2.12.2009 | EN 285:2006+A1:2008
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 455-1:2000
  Medical gloves for single use — Part 1: Requirements and testing for freedom from holes | 30.9.2005 | EN 455-1:1993
  Note 2.1 | Date expired
  (30.4.2001) |
| CEN | EN 455-2:2009+A2:2013
  Medical gloves for single use — Part 2: Requirements and testing for physical properties | 16.5.2014 | EN 455-2:2009+A1:2011
  Note 2.1 | Date expired
  (31.10.2014) |
| CEN | EN 455-3:2006
  Medical gloves for single use — Part 3: Requirements and testing for biological evaluation | 9.8.2007 | EN 455-3:1999
  Note 2.1 | Date expired
  (30.6.2007) |
| CEN | EN 455-4:2009
  Medical gloves for single use — Part 4: Requirements and testing for shelf life determination | 7.7.2010 | | |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | 31.7.2002 | EN 556:1994 + A1:1998
  Note 2.1 | Date expired
  (30.4.2002) |
| | EN 556-1:2001/AC:2006 | 15.11.2006 | | |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | 9.8.2007 | | |
| CEN | EN 794-3:1998+A2:2009
  Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators | 7.7.2010 | EN 794-3:1998
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | 19.2.2009 | EN 1041:1998
  Note 2.1 | Date expired
  (31.8.2011) |
| CEN | EN 1060-3:1997+A2:2009
  Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | 7.7.2010 | EN 1060-3:1997
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN 1060-4:2004
  Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers | 30.9.2005 | | |
| CEN | EN ISO 1135-4:2011
  Transfusion equipment for medical use — Part 4: Transfusion sets for single use (ISO 1135-4:2010) | 27.4.2012 | EN ISO 1135-4:2010
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN 1282-2:2005+A1:2009
  Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) | 7.7.2010 | EN 1282-2:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 1422:1997+A1:2009
  Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods | 2.12.2009 | EN 1422:1997
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 1618:1997
  Catheters other than intravascular catheters — Test methods for common properties | 9.5.1998 | | |
| CEN | EN 1639:2009
  Dentistry — Medical devices for dentistry — Instruments | 7.7.2010 | EN 1639:2004
  Note 2.1 | Date expired
  (30.4.2010) |
| CEN | EN 1640:2009
  Dentistry — Medical devices for dentistry — Equipment | 7.7.2010 | EN 1640:2004
  Note 2.1 | Date expired
  (30.4.2010) |
| CEN | EN 1641:2009
  Dentistry — Medical devices for dentistry — Materials | 7.7.2010 | EN 1641:2004
  Note 2.1 | Date expired
  (30.4.2010) |
| CEN | EN 1642:2011
  Dentistry — Medical devices for dentistry — Dental implants | 27.4.2012 | EN 1642:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN 1707:1996
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings | 17.5.1997 | | |
| CEN | EN 1782:1998+A1:2009
  Tracheal tubes and connectors | 7.7.2010 | EN 1782:1998
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 1789:2007+A1:2010
  Medical vehicles and their equipment — Road ambulances | 18.1.2011 | | |
| CEN | EN 1820:2005+A1:2009
  Anaesthetic reservoir bags (ISO 5362:2000, modified) | 7.7.2010 | EN 1820:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 1865-3:2012
  Patient handling equipment used in road ambulances — Part 3: Heavy duty stretcher | 30.8.2012 | EN 1865:1999
  Note 2.1 | Date expired
  (31.12.2012) |
| CEN | EN 1865-4:2012
  Patient handling equipment used in road ambulances — Part 4: Foldable patient transfer chair | 30.8.2012 | EN 1865:1999
  Note 2.1 | Date expired
  (31.10.2012) |
| CEN | EN 1865-5:2012
  Patient handling equipment used in road ambulances — Part 5: Stretcher support | 30.8.2012 | EN 1865:1999
  Note 2.1 | Date expired
  (31.12.2012) |
| CEN | EN 1985:1998
  Walking aids — General requirements and test methods | 10.8.1999 | | |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
| CEN | EN ISO 3826-2:2008
  Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) | 19.2.2009 | | |
| CEN | EN ISO 3826-3:2007
  Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) | 27.2.2008 | | |
| CEN | EN ISO 4074:2002
  Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002) | 31.7.2002 | EN 600:1996
  Note 2.1 | Date expired
  (31.8.2005) |
| | EN ISO 4074:2002/AC:2008 | 2.12.2009 | | |
| CEN | EN ISO 4135:2001
  Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) | 31.7.2002 | EN ISO 4135:1996
  Note 2.1 | Date expired
  (28.2.2002) |
| CEN | EN ISO 5356-1:2004
  Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004) | 30.9.2005 | EN 1281-1:1997
  Note 2.1 | Date expired
  (30.11.2004) |
| CEN | EN ISO 5359:2008
  Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) | 23.7.2008 | EN 739:1998
  Note 2.1 | Date expired
  (30.6.2010) |
| | EN ISO 5359:2008/A1:2011 | 30.8.2012 | Note 3 | Date expired
  (30.6.2012) |
| CEN | EN ISO 5360:2009
  Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006) | 2.12.2009 | EN ISO 5360:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 5366-1:2009
  Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) | 2.12.2009 | EN ISO 5366-1:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 5840:2009
  Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) | 2.12.2009 | EN ISO 5840:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 7197:2009
  Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) | 2.12.2009 | EN ISO 7197:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 7376:2009
  Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2009) | 2.12.2009 | EN ISO 7376:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 7396-1:2007
  Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) | 9.8.2007 | EN 737-3:1998
  Note 2.1 | Date expired
  (30.4.2009) |
| | EN ISO 7396-1:2007/A1:2010 | 7.7.2010 | Note 3 | Date expired
  (31.7.2010) |
| | EN ISO 7396-1:2007/A2:2010 | 7.7.2010 | Note 3 | Date expired
  (31.8.2010) |
| CEN | EN ISO 7396-2:2007
  Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) | 9.8.2007 | EN 737-2:1998
  Note 2.1 | Date expired
  (30.4.2009) |
| CEN | EN ISO 7886-3:2009
  Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) | 7.7.2010 | EN ISO 7886-3:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 7886-4:2009
  Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) | 7.7.2010 | EN ISO 7886-4:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 8185:2009
  Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007) | 2.12.2009 | EN ISO 8185:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 8359:2009
  Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) | 2.12.2009 | EN ISO 8359:1996
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 8359:2009/A1:2012 | This is the first publication | Note 3 | Date expired
  (31.1.2013) |
| CEN | EN ISO 8835-2:2009
  Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) | 2.12.2009 | EN ISO 8835-2:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 8835-3:2009
  Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) | 2.12.2009 | EN ISO 8835-3:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 8835-3:2009/A1:2010 | 13.5.2011 | Note 3 | Date expired
  (30.4.2011) |
| CEN | EN ISO 8835-4:2009
  Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) | 2.12.2009 | EN ISO 8835-4:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 8835-5:2009
  Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004) | 2.12.2009 | EN ISO 8835-5:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 9170-1:2008
  Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) | 19.2.2009 | EN 737-1:1998
  Note 2.1 | Date expired
  (31.7.2010) |
| CEN | EN ISO 9170-2:2008
  Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) | 19.2.2009 | EN 737-4:1998
  Note 2.1 | Date expired
  (31.7.2010) |
| CEN | EN ISO 9360-1:2009
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) | 2.12.2009 | EN ISO 9360-1:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 9360-2:2009
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) | 2.12.2009 | EN ISO 9360-2:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 9713:2009
  Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) | 2.12.2009 | EN ISO 9713:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10079-1:2009
  Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) | 2.12.2009 | EN ISO 10079-1:1999
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10079-2:2009
  Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) | 2.12.2009 | EN ISO 10079-2:1999
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10079-3:2009
  Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) | 2.12.2009 | EN ISO 10079-3:1999
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10328:2006
  Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006) | 9.8.2007 | | |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
| CEN | EN ISO 10524-1:2006
  Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) | 2.6.2006 | EN 738-1:1997
  Note 2.1 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-2:2006
  Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) | 7.6.2009 | EN 738-2:1998
  Note 2.1 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-3:2006
  Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) | 7.9.2006 | EN 738-3:1998
  Note 2.1 | Date expired
  (31.10.2008) |
| CEN | EN ISO 10524-4:2008
  Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008) | 23.7.2008 | EN 738-4:1998
  Note 2.1 | Date expired
  (30.6.2010) |
| CEN | EN ISO 10535:2006
  Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006) | 9.8.2007 | EN ISO 10535:1998
  Note 2.1 | Date expired
  (30.6.2007) |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
| CEN | EN ISO 10555-1:2009
  Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) | 2.12.2009 | EN ISO 10555-1:1996
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10651-2:2009
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) | 2.12.2009 | EN ISO 10651-2:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10651-4:2009
  Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | 2.12.2009 | EN ISO 10651-4:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10651-6:2009
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) | 2.12.2009 | EN ISO 10651-6:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-1:2009
  Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | 2.12.2009 | EN ISO 10993-1:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 10993-1:2009/AC:2010 | 18.1.2011 | | |
| CEN | EN ISO 10993-3:2009
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) | 2.12.2009 | EN ISO 10993-3:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-4:2009
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) | 2.12.2009 | EN ISO 10993-4:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-5:2009
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | 2.12.2009 | EN ISO 10993-5:1999
  Note 2.1 | Date expired
  (31.12.2009) |
| CEN | EN ISO 10993-6:2009
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | 2.12.2009 | EN ISO 10993-6:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-7:2008
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) | 19.2.2009 | | |
| | EN ISO 10993-7:2008/AC:2009 | 7.7.2010 | | |
| CEN | EN ISO 10993-9:2009
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) | 2.12.2009 | EN ISO 10993-9:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-11:2009
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | 2.12.2009 | EN ISO 10993-11:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-12:2012
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012) | 24.1.2013 | EN ISO 10993-12:2009
  Note 2.1 | Date expired
  (31.1.2013) |
| CEN | EN ISO 10993-13:2010
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) | 18.1.2011 | EN ISO 10993-13:2009
  Note 2.1 | Date expired
  (31.12.2010) |
| CEN | EN ISO 10993-14:2009
  Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) | 2.12.2009 | EN ISO 10993-14:2001
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-15:2009
  Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) | 2.12.2009 | EN ISO 10993-15:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-16:2010
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) | 7.7.2010 | EN ISO 10993-16:2009
  Note 2.1 | Date expired
  (31.8.2010) |
| CEN | EN ISO 10993-17:2009
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | 2.12.2009 | EN ISO 10993-17:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 10993-18:2009
  Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005) | 2.12.2009 | EN ISO 10993-18:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11135-1:2007
  Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) | 9.8.2007 | EN 550:1994
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN ISO 11137-1:2006
  Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) | 7.9.2006 | EN 552:1994
  Note 2.1 | Date expired
  (30.4.2009) |
| | EN ISO 11137-1:2006/A1:2013 | 16.5.2014 | Note 3 | Date expired
  (30.11.2014) |
| CEN | EN ISO 11137-2:2013
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | 16.5.2014 | EN ISO 11137-2:2012
  Note 2.1 | Date expired
  (30.11.2014) |
| CEN | EN ISO 11138-2:2009
  Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) | 2.12.2009 | EN ISO 11138-2:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11138-3:2009
  Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) | 2.12.2009 | EN ISO 11138-3:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11140-1:2009
  Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | 2.12.2009 | EN ISO 11140-1:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11140-3:2009
  Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) | 2.12.2009 | EN ISO 11140-3:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11197:2009
  Medical supply units (ISO 11197:2004) | 2.12.2009 | EN ISO 11197:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11607-1:2009
  Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | 2.12.2009 | EN ISO 11607-1:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11607-2:2006
  Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) | 7.9.2006 | | |
| CEN | EN ISO 11737-1:2006
  Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | 7.9.2006 | EN 1174-2:1996
  EN 1174-1:1996
  EN 1174-3:1996
  Note 2.1 | Date expired
  (31.10.2006) |
| | EN ISO 11737-1:2006/AC:2009 | 2.12.2009 | | |
| CEN | EN ISO 11737-2:2009
  Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) | 7.7.2010 | | |
| CEN | EN ISO 11810-1:2009
  Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Part 1: Primary ignition and penetration (ISO 11810-1:2005) | 2.12.2009 | | |
| CEN | EN ISO 11810-2:2009
  Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007) | 2.12.2009 | EN ISO 11810-2:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 11979-8:2009
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) | 2.12.2009 | EN ISO 11979-8:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12006-2:1998+A1:2009
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits | 2.12.2009 | EN 12006-2:1998
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12183:2009
  Manual wheelchairs — Requirements and test methods | 7.7.2010 | | |
| CEN | EN 12184:2009
  Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods | 7.7.2010 | | |
| CEN | EN 12342:1998+A1:2009
  Breathing tubes intended for use with anaesthetic apparatus and ventilators | 7.7.2010 | EN 12342:1998
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12470-1:2000+A1:2009
  Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device | 2.12.2009 | EN 12470-1:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12470-2:2000+A1:2009
  Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers | 2.12.2009 | EN 12470-2:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 12870:2009
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) | 2.12.2009 | EN ISO 12870:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13060:2004+A2:2010
  Small steam sterilizers | 7.7.2010 | EN 13060:2004+A1:2009
  Note 2.1 | Date expired
  (30.9.2010) |
| CEN | EN ISO 13408-1:2011
  Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| | EN ISO 13408-1:2011/A1:2013 | 16.5.2014 | Note 3 | Date expired
  (30.11.2014) |
| CEN | EN ISO 13408-2:2011
  Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-3:2011
  Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-4:2011
  Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-5:2011
  Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13408-6:2011
  Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) | 19.8.2011 | EN 13824:2004
  Note 2.1 | Date expired
  (31.12.2011) |
| CEN | EN ISO 13485:2012
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | 30.8.2012 | EN ISO 13485:2003
  Note 2.1 | Date expired
  (31.8.2012) |
| | EN ISO 13485:2012/AC:2012 | 30.8.2012 | | |
| CEN | EN 13544-1:2007+A1:2009
  Respiratory therapy equipment — Part 1: Nebulizing systems and their components | 7.7.2010 | EN 13544-1:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13544-2:2002+A1:2009
  Respiratory therapy equipment — Part 2: Tubing and connectors | 7.7.2010 | EN 13544-2:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13544-3:2001+A1:2009
  Respiratory therapy equipment — Part 3: Air entrainment devices | 7.7.2010 | EN 13544-3:2001
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13624:2003
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) | 30.9.2005 | | |
| CEN | EN 13718-1:2008
  Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances | 19.2.2009 | EN 13718-1:2002
  Note 2.1 | Date expired
  (28.2.2009) |
| CEN | EN 13726-1:2002
  Test methods for primary wound dressings — Part 1: Aspects of absorbency | 27.3.2003 | | |
| | EN 13726-1:2002/AC:2003 | 2.12.2009 | | |
| CEN | EN 13726-2:2002
  Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings | 27.3.2003 | | |
| CEN | EN 13727:2012
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity in the medical area — Test method and requirements (phase 2, step 1) | 30.8.2012 | EN 13727:2003
  Note 2.1 | Date expired
  (30.11.2012) |
| CEN | EN 13867:2002+A1:2009
  Concentrates for haemodialysis and related therapies | 2.12.2009 | EN 13867:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13976-1:2011
  Rescue systems — Transportation of incubators — Part 1: Interface conditions | 19.8.2011 | EN 13976-1:2003
  Note 2.1 | Date expired
  (30.11.2011) |
| CEN | EN 13976-2:2011
  Rescue systems — Transportation of incubators — Part 2: System requirements | 19.8.2011 | EN 13976-2:2003
  Note 2.1 | Date expired
  (30.11.2011) |
| CEN | EN 14079:2003
  Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | 30.9.2005 | | |
| CEN | EN 14139:2010
  Ophthalmic optics — Specifications for ready-to-wear spectacles | 18.1.2011 | | |
| CEN | EN ISO 14155:2011
  Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011) | 27.4.2012 | EN ISO 14155:2011
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN 14180:2003+A2:2009
  Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing | 7.7.2010 | EN 14180:2003+A1:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 14348:2005
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1) | 30.9.2005 | | |
| CEN | EN ISO 14408:2009
  Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) | 2.12.2009 | EN ISO 14408:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 14561:2006
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) | 15.11.2006 | | |
| CEN | EN 14562:2006
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2) | 15.11.2006 | | |
| CEN | EN 14563:2008
  Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area — Test method and requirements (phase 2, step 2) | 19.2.2009 | | |
| CEN | EN ISO 14602:2011
  Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:2010) | 27.4.2012 | EN ISO 14602:2010
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 14607:2009
  Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007) | 2.12.2009 | EN ISO 14607:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 14683:2005
  Surgical masks — Requirements and test methods | 2.6.2006 | | |
| CEN | EN ISO 14889:2009
  Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) | 2.12.2009 | EN ISO 14889:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 14931:2006
  Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing | 15.11.2006 | | |
| CEN | EN ISO 14937:2009
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) | 7.7.2010 | EN ISO 14937:2000
  Note 2.1 | Date expired
  (30.4.2010) |
| CEN | EN ISO 14971:2012
  Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 30.8.2012 | EN ISO 14971:2009
  Note 2.1 | Date expired
  (30.8.2012) |
| CEN | EN ISO 15001:2011
  Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2010) | 27.4.2012 | EN ISO 15001:2010
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 15002:2008
  Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) | 19.2.2009 | EN 13220:1998
  Note 2.1 | Date expired
  (31.7.2010) |
| CEN | EN ISO 15004-1:2009
  Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) | 2.12.2009 | EN ISO 15004-1:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 15747:2011
  Plastic containers for intravenous injections (ISO 15747:2010) | 27.4.2012 | EN ISO 15747:2010
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 15798:2010
  Ophthalmic implants — Ophthalmic viscosurgical devices (ISO 15798:2010) | 7.7.2010 | | |
| CEN | EN ISO 15883-1:2009
  Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) | 2.12.2009 | EN ISO 15883-1:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 15883-2:2009
  Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) | 2.12.2009 | EN ISO 15883-2:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 15883-3:2009
  Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) | 2.12.2009 | EN ISO 15883-3:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 15883-4:2009
  Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) | 2.12.2009 | EN ISO 15883-4:2008
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 15986:2011
  Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates | 13.5.2011 | | |
| CEN | EN ISO 16061:2009
  Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008, Corrected version 2009-03-15) | 7.7.2010 | EN ISO 16061:2008
  Note 2.1 | Date expired
  (28.2.2010) |
| CEN | EN ISO 16201:2006
  Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006) | 19.2.2009 | | |
| CEN | EN ISO 17510-1:2009
  Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) | 2.12.2009 | EN ISO 17510-1:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 17510-2:2009
  Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007) | 2.12.2009 | EN ISO 17510-2:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 17664:2004
  Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) | 30.9.2005 | | |
| CEN | EN ISO 17665-1:2006
  Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) | 15.11.2006 | EN 554:1994
  Note 2.1 | Date expired
  (31.8.2009) |
| CEN | EN ISO 18777:2009
  Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) | 2.12.2009 | EN ISO 18777:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 18778:2009
  Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) | 2.12.2009 | EN ISO 18778:2005
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 18779:2005
  Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005) | 30.9.2005 | | |
| CEN | EN ISO 19054:2006
  Rail systems for supporting medical equipment (ISO 19054:2005) | 7.9.2006 | EN 12218:1998
  Note 2.1 | Date expired
  (30.6.2008) |
| CEN | EN 20594-1:1993
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) | 18.11.1995 | | |
| | EN 20594-1:1993/A1:1997 | 10.8.1999 | Note 3 | Date expired
  (31.5.1998) |
| | EN 20594-1:1993/AC:1996 | 2.12.2009 | | |
| CEN | EN ISO 21534:2009
  Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007) | 2.12.2009 | EN ISO 21534:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 21535:2009
  Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007) | 2.12.2009 | EN ISO 21535:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 21536:2009
  Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007) | 2.12.2009 | EN ISO 21536:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 21649:2009
  Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006) | 7.7.2010 | EN ISO 21649:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 21969:2009
  High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) | 7.7.2010 | EN ISO 21969:2006
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN ISO 21987:2009
  Ophthalmic optics — Mounted spectacle lenses (ISO 21987:2009) | 7.7.2010 | | |
| CEN | EN ISO 22442-1:2007
  Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007) | 27.2.2008 | EN 12442-1:2000
  Note 2.1 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22442-2:2007
  Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) | 27.2.2008 | EN 12442-2:2000
  Note 2.1 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22442-3:2007
  Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) | 27.2.2008 | EN 12442-3:2000
  Note 2.1 | Date expired
  (30.6.2008) |
| CEN | EN ISO 22523:2006
  External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006) | 9.8.2007 | EN 12523:1999
  Note 2.1 | Date expired
  (30.4.2007) |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
| CEN | EN ISO 22675:2006
  Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006) | 9.8.2007 | | |
| This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. |
| CEN | EN ISO 23328-1:2008
  Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003) | 19.2.2009 | EN 13328-1:2001
  Note 2.1 | Date expired
  (30.9.2008) |
| CEN | EN ISO 23328-2:2009
  Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002) | 2.12.2009 | EN ISO 23328-2:2008
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 23747:2009
  Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) | 2.12.2009 | EN ISO 23747:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 25539-1:2009
  Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) | 2.12.2009 | EN ISO 25539-1:2008
  EN 12006-3:1998+A1:2009
  Note 2.1 | Date expired
  (21.3.2010) |
| | EN ISO 25539-1:2009/AC:2011 | 30.8.2012 | | |
| CEN | EN ISO 26782:2009
  Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) | 7.7.2010 | | |
| | EN ISO 26782:2009/AC:2009 | 7.7.2010 | | |
| CEN | EN 27740:1992
  Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | 18.11.1995 | | |
| | EN 27740:1992/A1:1997 | 10.8.1999 | Note 3 | Date expired
  (31.5.1998) |
| | EN 27740:1992/AC:1996 | 2.12.2009 | | |
| CEN | EN ISO 81060-1:2012
  Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) | 30.8.2012 | EN 1060-2:1995+A1:2009
  EN 1060-1:1995+A2:2009
  Note 2.1 | Date expired
  (31.5.2015) |
| Cenelec | EN 60118-13:2005
  Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)
  IEC 60118-13:2004 | 19.1.2006 | EN 60118-13:1997
  Note 2.1 | Date expired
  (1.2.2008) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies
  IEC 60522:1999 | 14.11.2001 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60580:2000
  Medical electrical equipment — Dose area product meters
  IEC 60580:2000 | 13.12.2002 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 | 27.11.2008 | EN 60601-1-4:1996
  EN 60601-1:1990
  EN 60601-1-1:2001
  Note 2.1 | Date expired
  (1.6.2012) |
| | EN 60601-1:2006/AC:2010 | 18.1.2011 | | |
| | EN 60601-1:2006/A1:2013
  IEC 60601-1:2005/A1:2012 | 16.5.2014 | Note 3 | Date expired
  (31.12.2017) |
| Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013. |
| Cenelec | EN 60601-1-1:2001
  Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
  IEC 60601-1-1:2000 | 14.11.2001 | | Date expired
  (1.11.2003) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-2:2007
  Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
  IEC 60601-1-2:2007 (Modified) | 27.11.2008 | EN 60601-1-2:2001 | Date expired
  (1.6.2012) |
| | EN 60601-1-2:2007/AC:2010 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-3:2008
  Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment
  IEC 60601-1-3:2008 | 27.11.2008 | EN 60601-1-3:1994
  Note 2.1 | Date expired
  (1.6.2012) |
| | EN 60601-1-3:2008/AC:2010 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-4:1996
  Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems
  IEC 60601-1-4:1996 | 8.11.1997 | | |
| | EN 60601-1-4:1996/A1:1999
  IEC 60601-1-4:1996/A1:1999 | 8.11.1997 | Note 3 | Date expired
  (1.12.2002) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-6:2010
  Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
  IEC 60601-1-6:2010 | 18.1.2011 | EN 60601-1-6:2007
  Note 2.1 | Date expired
  (1.4.2013) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-8:2007
  Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  IEC 60601-1-8:2006 | 27.11.2008 | EN 60601-1-8:2004
  Note 2.1 | Date expired
  (1.6.2012) |
| | EN 60601-1-8:2007/AC:2010 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-10:2008
  Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  IEC 60601-1-10:2007 | 27.11.2008 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-1-11:2010
  Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  IEC 60601-1-11:2010 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-1:1998
  Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
  IEC 60601-2-1:1998 | 14.11.2001 | | |
| | EN 60601-2-1:1998/A1:2002
  IEC 60601-2-1:1998/A1:2002 | 13.12.2002 | Note 3 | Date expired
  (1.6.2005) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-2:2009
  Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  IEC 60601-2-2:2009 | 7.7.2010 | EN 60601-2-2:2007
  Note 2.1 | Date expired
  (1.4.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-3:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment
  IEC 60601-2-3:1991 | 18.11.1995 | | |
| | EN 60601-2-3:1993/A1:1998
  IEC 60601-2-3:1991/A1:1998 | 18.11.1995 | Note 3 | Date expired
  (1.7.2001) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-4:2003
  Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators
  IEC 60601-2-4:2002 | 15.10.2003 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-5:2000
  Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
  IEC 60601-2-5:2000 | 13.12.2002 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-8:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
  IEC 60601-2-8:1987 | 14.11.2001 | | |
| | EN 60601-2-8:1997/A1:1997
  IEC 60601-2-8:1987/A1:1997 | 14.11.2001 | Note 3 | Date expired
  (1.7.1998) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-10:2000
  Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
  IEC 60601-2-10:1987 | 13.12.2002 | | |
| | EN 60601-2-10:2000/A1:2001
  IEC 60601-2-10:1987/A1:2001 | 13.12.2002 | Note 3 | Date expired
  (1.11.2004) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-11:1997
  Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
  IEC 60601-2-11:1997 | 9.10.1999 | | |
| | EN 60601-2-11:1997/A1:2004
  IEC 60601-2-11:1997/A1:2004 | 9.10.1999 | Note 3 | Date expired
  (1.9.2007) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-12:2006
  Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators
  IEC 60601-2-12:2001 | 22.12.2007 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-13:2006
  Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
  IEC 60601-2-13:2003 | 22.12.2007 | | |
| | EN 60601-2-13:2006/A1:2007
  IEC 60601-2-13:2003/A1:2006 | 22.12.2007 | Note 3 | Date expired
  (1.3.2010) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-16:1998
  Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  IEC 60601-2-16:1998 | 9.10.1999 | | |
| | EN 60601-2-16:1998/AC:1999 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-17:2004
  Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
  IEC 60601-2-17:2004 | 8.11.2005 | | Date expired
  (1.3.2007) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-18:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment
  IEC 60601-2-18:1996 | 9.10.1999 | | |
| | EN 60601-2-18:1996/A1:2000
  IEC 60601-2-18:1996/A1:2000 | 9.10.1999 | Note 3 | Date expired
  (1.8.2003) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-19:2009
  Medical electrical equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
  IEC 60601
  IEC 60601-2-19:2009 | 7.7.2010 | EN 60601-2-19:1996
  Note 2.1 | Date expired
  (1.4.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-20:2009
  Medical electrical equipment — Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
  IEC 60601
  IEC 60601-2-20:2009 | 18.1.2011 | EN 60601-2-20:1996
  Note 2.1 | Date expired
  (1.9.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-21:2009
  Medical electrical equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
  IEC 60601-2-21:2009 | 7.7.2010 | EN 60601-2-21:1994
  Note 2.1 | Date expired
  (1.4.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-22:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
  IEC 60601-2-22:1995 | 17.5.1997 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-23:2000
  Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
  IEC 60601-2-23:1999 | 14.11.2001 | | Date expired
  (1.1.2003) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-24:1998
  Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers
  IEC 60601-2-24:1998 | 9.10.1999 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-25:1995
  Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs
  IEC 60601-2-25:1993 | 17.5.1997 | | |
| | EN 60601-2-25:1995/A1:1999
  IEC 60601-2-25:1993/A1:1999 | 13.12.2002 | Note 3 | Date expired
  (1.5.2002) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-26:2003
  Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs
  IEC 60601-2-26:2002 | 8.11.2005 | | Date expired
  (1.3.2006) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-27:2006
  Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
  IEC 60601-2-27:2005 | 26.7.2006 | | Date expired
  (1.11.2008) |
| | EN 60601-2-27:2006/AC:2006 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-28:2010
  Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
  IEC 60601-2-28:2010 | 18.1.2011 | EN 60601-2-28:1993
  Note 2.1 | Date expired
  (1.4.2013) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-29:2008
  Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
  IEC 60601-2-29:2008 | 15.7.2009 | EN 60601-2-29:1999
  Note 2.1 | Date expired
  (1.11.2011) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-34:2000
  Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
  IEC 60601-2-34:2000 | 15.10.2003 | | Date expired
  (1.11.2003) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-36:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  IEC 60601-2-36:1997 | 9.10.1999 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-37:2008
  Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  IEC 60601-2-37:2007 | 27.11.2008 | EN 60601-2-37:2001
  Note 2.1 | Date expired
  (1.10.2010) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-39:2008
  Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
  IEC 60601-2-39:2007 | 27.11.2008 | EN 60601-2-39:1999
  Note 2.1 | Date expired
  (1.3.2011) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-40:1998
  Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
  IEC 60601-2-40:1998 | 9.10.1999 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-41:2009
  Medical electrical equipment — Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
  IEC 60601-2-41:2009 | 18.1.2011 | EN 60601-2-41:2000
  Note 2.1 | Date expired
  (1.11.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-43:2010
  Medical electrical equipment — Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
  IEC 60601-2-43:2010 | 18.1.2011 | EN 60601-2-43:2000
  Note 2.1 | Date expired
  (1.6.2013) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-44:2009
  Medical electrical equipment — Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
  IEC 60601-2-44:2009 | 7.7.2010 | EN 60601-2-44:2001
  Note 2.1 | Date expired
  (1.5.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-45:2001
  Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
  IEC 60601-2-45:2001 | 14.11.2001 | EN 60601-2-45:1998
  Note 2.1 | Date expired
  (1.7.2004) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-46:1998
  Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables
  IEC 60601-2-46:1998 | 14.11.2001 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-47:2001
  Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  IEC 60601-2-47:2001 | 13.12.2002 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-49:2001
  Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
  IEC 60601-2-49:2001 | 13.12.2002 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-50:2009
  Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
  IEC 60601-2-50:2009 | 7.7.2010 | EN 60601-2-50:2002
  Note 2.1 | Date expired
  (1.5.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-51:2003
  Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
  IEC 60601-2-51:2003 | 24.6.2004 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-52:2010
  Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009) | 13.5.2011 | EN 1970:2000
  EN 60601-2-38:1996 | Date expired
  (1.6.2012) |
| | EN 60601-2-52:2010/AC:2011 | 30.8.2012 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60601-2-54:2009
  Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  IEC 60601-2-54:2009 | 18.1.2011 | EN 60601-2-32:1994
  EN 60601-2-7:1998 | Date expired
  (1.8.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60627:2001
  Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids
  IEC 60627:2001 | 13.12.2002 | | |
| | EN 60627:2001/AC:2002 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60645-1:2001
  Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers
  IEC 60645-1:2001 | 13.12.2002 | | Date expired
  (1.10.2004) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60645-2:1997
  Audiometers — Part 2: Equipment for speech audiometry
  IEC 60645-2:1993 | 17.5.1997 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60645-3:2007
  Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration
  IEC 60645-3:2007 | 27.11.2008 | EN 60645-3:1995
  Note 2.1 | Date expired
  (1.6.2010) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 60645-4:1995
  Audiometers — Part 4: Equipment for extended high-frequency audiometry
  IEC 60645-4:1994 | 23.8.1996 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 61217:1996
  Radiotherapy equipment — Coordinates, movements and scales
  IEC 61217:1996 | 14.11.2001 | | |
| | EN 61217:1996/A1:2001
  IEC 61217:1996/A1:2000 | 14.11.2001 | Note 3 | Date expired
  (1.12.2003) |
| | EN 61217:1996/A2:2008
  IEC 61217:1996/A2:2007 | 27.11.2008 | Note 3 | Date expired
  (1.2.2011) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 61217:2012
  Radiotherapy equipment — Coordinates, movements and scales
  IEC 61217:2011 | 30.8.2012 | EN 61217:1996 | Date expired
  (11.1.2015) |
| Cenelec | EN 61676:2002
  Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
  IEC 61676:2002 | 15.10.2003 | | |
| | EN 61676:2002/A1:2009
  IEC 61676:2002/A1:2008 | 7.7.2010 | Note 3 | Date expired
  (1.3.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62083:2009
  Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
  IEC 62083:2009 | 18.1.2011 | EN 62083:2001
  Note 2.1 | Date expired
  (1.11.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62220-1:2004
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency
  IEC 62220-1:2003 | 24.6.2004 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62220-1-2:2007
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography
  IEC 62220-1-2:2007 | 27.11.2008 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62220-1-3:2008
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-3: Determination of the detective quantum efficiency — Detectors used in dynamic imaging
  IEC 62220-1-3:2008 | 15.7.2009 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| | EN 62304:2006/AC:2008 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  IEC 62366:2007 | 27.11.2008 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 80601-2-35:2009
  Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
  IEC 80601
  IEC 80601-2-35:2009 | 18.1.2011 | EN 60601-2-35:1996
  Note 2.1 | Date expired
  (1.11.2012) |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 80601-2-58:2009
  Medical electrical equipment — Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
  IEC 80601-2-58:2008 | 7.7.2010 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
| Cenelec | EN 80601-2-59:2009
  Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
  IEC 80601
  IEC 80601-2-59:2008 | 18.1.2011 | | |
| (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |

ESO (1)

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

(5)

CEN

EN 285:2006+A2:2009

Sterilization — Steam sterilizers — Large sterilizers

2.12.2009

EN 285:2006+A1:2008

Note 2.1

Date expired

(21.3.2010)

CEN

EN 455-1:2000

Medical gloves for single use — Part 1: Requirements and testing for freedom from holes

30.9.2005

EN 455-1:1993

Note 2.1

Date expired

(30.4.2001)

CEN

EN 455-2:2009+A2:2013

Medical gloves for single use — Part 2: Requirements and testing for physical properties

16.5.2014

EN 455-2:2009+A1:2011

Note 2.1

Date expired

(31.10.2014)

CEN

EN 455-3:2006

Medical gloves for single use — Part 3: Requirements and testing for biological evaluation

9.8.2007

EN 455-3:1999

Note 2.1

Date expired

(30.6.2007)

CEN

EN 455-4:2009

Medical gloves for single use — Part 4: Requirements and testing for shelf life determination

7.7.2010

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

31.7.2002

EN 556:1994 + A1:1998

Note 2.1

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

15.11.2006

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

9.8.2007

CEN

EN 794-3:1998+A2:2009

Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators

7.7.2010

EN 794-3:1998

Note 2.1

Date expired

(21.3.2010)

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

Date expired

(31.5.2010)

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

19.2.2009

EN 1041:1998

Note 2.1

Date expired

(31.8.2011)

CEN

EN 1060-3:1997+A2:2009

Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

7.7.2010

EN 1060-3:1997

Note 2.1

Date expired

(31.5.2010)

CEN

EN 1060-4:2004

Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

30.9.2005

CEN

EN ISO 1135-4:2011

Transfusion equipment for medical use — Part 4: Transfusion sets for single use (ISO 1135-4:2010)

27.4.2012

EN ISO 1135-4:2010

Note 2.1

Date expired

(30.4.2012)

CEN

EN 1282-2:2005+A1:2009

Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

7.7.2010

EN 1282-2:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN 1422:1997+A1:2009

Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods

2.12.2009

EN 1422:1997

Note 2.1

Date expired

(21.3.2010)

CEN

EN 1618:1997

Catheters other than intravascular catheters — Test methods for common properties

9.5.1998

CEN

EN 1639:2009

Dentistry — Medical devices for dentistry — Instruments

7.7.2010

EN 1639:2004

Note 2.1

Date expired

(30.4.2010)

CEN

EN 1640:2009

Dentistry — Medical devices for dentistry — Equipment

7.7.2010

EN 1640:2004

Note 2.1

Date expired

(30.4.2010)

CEN

EN 1641:2009

Dentistry — Medical devices for dentistry — Materials

7.7.2010

EN 1641:2004

Note 2.1

Date expired

(30.4.2010)

CEN

EN 1642:2011

Dentistry — Medical devices for dentistry — Dental implants

27.4.2012

EN 1642:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN 1707:1996

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings

17.5.1997

CEN

EN 1782:1998+A1:2009

Tracheal tubes and connectors

7.7.2010

EN 1782:1998

Note 2.1

Date expired

(21.3.2010)

CEN

EN 1789:2007+A1:2010

Medical vehicles and their equipment — Road ambulances

18.1.2011

CEN

EN 1820:2005+A1:2009

Anaesthetic reservoir bags (ISO 5362:2000, modified)

7.7.2010

EN 1820:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN 1865-3:2012

Patient handling equipment used in road ambulances — Part 3: Heavy duty stretcher

30.8.2012

EN 1865:1999

Note 2.1

Date expired

(31.12.2012)

CEN

EN 1865-4:2012

Patient handling equipment used in road ambulances — Part 4: Foldable patient transfer chair

30.8.2012

EN 1865:1999

Note 2.1

Date expired

(31.10.2012)

CEN

EN 1865-5:2012

Patient handling equipment used in road ambulances — Part 5: Stretcher support

30.8.2012

EN 1865:1999

Note 2.1

Date expired

(31.12.2012)

CEN

EN 1985:1998

Walking aids — General requirements and test methods

10.8.1999

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

CEN

EN ISO 3826-2:2008

Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

19.2.2009

CEN

EN ISO 3826-3:2007

Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

27.2.2008

CEN

EN ISO 4074:2002

Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002)

31.7.2002

EN 600:1996

Note 2.1

Date expired

(31.8.2005)

EN ISO 4074:2002/AC:2008

2.12.2009

CEN

EN ISO 4135:2001

Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001)

31.7.2002

EN ISO 4135:1996

Note 2.1

Date expired

(28.2.2002)

CEN

EN ISO 5356-1:2004

Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004)

30.9.2005

EN 1281-1:1997

Note 2.1

Date expired

(30.11.2004)

CEN

EN ISO 5359:2008

Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

23.7.2008

EN 739:1998

Note 2.1

Date expired

(30.6.2010)

EN ISO 5359:2008/A1:2011

30.8.2012

Note 3

Date expired

(30.6.2012)

CEN

EN ISO 5360:2009

Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006)

2.12.2009

EN ISO 5360:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 5366-1:2009

Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

2.12.2009

EN ISO 5366-1:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 5840:2009

Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)

2.12.2009

EN ISO 5840:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 7197:2009

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

2.12.2009

EN ISO 7197:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 7376:2009

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2009)

2.12.2009

EN ISO 7376:2009

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 7396-1:2007

Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

9.8.2007

EN 737-3:1998

Note 2.1

Date expired

(30.4.2009)

EN ISO 7396-1:2007/A1:2010

7.7.2010

Note 3

Date expired

(31.7.2010)

EN ISO 7396-1:2007/A2:2010

7.7.2010

Note 3

Date expired

(31.8.2010)

CEN

EN ISO 7396-2:2007

Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

9.8.2007

EN 737-2:1998

Note 2.1

Date expired

(30.4.2009)

CEN

EN ISO 7886-3:2009

Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

7.7.2010

EN ISO 7886-3:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 7886-4:2009

Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

7.7.2010

EN ISO 7886-4:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 8185:2009

Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007)

2.12.2009

EN ISO 8185:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 8359:2009

Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)

2.12.2009

EN ISO 8359:1996

Note 2.1

Date expired

(21.3.2010)

EN ISO 8359:2009/A1:2012

This is the first publication

Note 3

Date expired

(31.1.2013)

CEN

EN ISO 8835-2:2009

Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

2.12.2009

EN ISO 8835-2:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 8835-3:2009

Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

2.12.2009

EN ISO 8835-3:2007

Note 2.1

Date expired

(21.3.2010)

EN ISO 8835-3:2009/A1:2010

13.5.2011

Note 3

Date expired

(30.4.2011)

CEN

EN ISO 8835-4:2009

Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

2.12.2009

EN ISO 8835-4:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 8835-5:2009

Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

2.12.2009

EN ISO 8835-5:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 9170-1:2008

Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)

19.2.2009

EN 737-1:1998

Note 2.1

Date expired

(31.7.2010)

CEN

EN ISO 9170-2:2008

Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

19.2.2009

EN 737-4:1998

Note 2.1

Date expired

(31.7.2010)

CEN

EN ISO 9360-1:2009

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

2.12.2009

EN ISO 9360-1:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 9360-2:2009

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

2.12.2009

EN ISO 9360-2:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 9713:2009

Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002)

2.12.2009

EN ISO 9713:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10079-1:2009

Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999)

2.12.2009

EN ISO 10079-1:1999

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10079-2:2009

Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999)

2.12.2009

EN ISO 10079-2:1999

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10079-3:2009

Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

2.12.2009

EN ISO 10079-3:1999

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10328:2006

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods (ISO 10328:2006)

9.8.2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

CEN

EN ISO 10524-1:2006

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

2.6.2006

EN 738-1:1997

Note 2.1

Date expired

(31.10.2008)

CEN

EN ISO 10524-2:2006

Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

7.6.2009

EN 738-2:1998

Note 2.1

Date expired

(31.10.2008)

CEN

EN ISO 10524-3:2006

Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

7.9.2006

EN 738-3:1998

Note 2.1

Date expired

(31.10.2008)

CEN

EN ISO 10524-4:2008

Pressure regulators for use with medical gases — Part 4: Low-pressure regulators (ISO 10524-4:2008)

23.7.2008

EN 738-4:1998

Note 2.1

Date expired

(30.6.2010)

CEN

EN ISO 10535:2006

Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:2006)

9.8.2007

EN ISO 10535:1998

Note 2.1

Date expired

(30.6.2007)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

CEN

EN ISO 10555-1:2009

Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

2.12.2009

EN ISO 10555-1:1996

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10651-2:2009

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

2.12.2009

EN ISO 10651-2:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10651-4:2009

Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

2.12.2009

EN ISO 10651-4:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10651-6:2009

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

2.12.2009

EN ISO 10651-6:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

2.12.2009

EN ISO 10993-1:2009

Note 2.1

Date expired

(21.3.2010)

EN ISO 10993-1:2009/AC:2010

18.1.2011

CEN

EN ISO 10993-3:2009

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

2.12.2009

EN ISO 10993-3:2003

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-4:2009

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

2.12.2009

EN ISO 10993-4:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

2.12.2009

EN ISO 10993-5:1999

Note 2.1

Date expired

(31.12.2009)

CEN

EN ISO 10993-6:2009

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

2.12.2009

EN ISO 10993-6:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

19.2.2009

EN ISO 10993-7:2008/AC:2009

7.7.2010

CEN

EN ISO 10993-9:2009

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

2.12.2009

EN ISO 10993-9:2009

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-11:2009

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

2.12.2009

EN ISO 10993-11:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

24.1.2013

EN ISO 10993-12:2009

Note 2.1

Date expired

(31.1.2013)

CEN

EN ISO 10993-13:2010

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

18.1.2011

EN ISO 10993-13:2009

Note 2.1

Date expired

(31.12.2010)

CEN

EN ISO 10993-14:2009

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

2.12.2009

EN ISO 10993-14:2001

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-15:2009

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

2.12.2009

EN ISO 10993-15:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-16:2010

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

7.7.2010

EN ISO 10993-16:2009

Note 2.1

Date expired

(31.8.2010)

CEN

EN ISO 10993-17:2009

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

2.12.2009

EN ISO 10993-17:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 10993-18:2009

Biological evaluation of medical devices — Part 18: Chemical characterization of materials (ISO 10993-18:2005)

2.12.2009

EN ISO 10993-18:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

9.8.2007

EN 550:1994

Note 2.1

Date expired

(31.5.2010)

CEN

EN ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)

7.9.2006

EN 552:1994

Note 2.1

Date expired

(30.4.2009)

EN ISO 11137-1:2006/A1:2013

16.5.2014

Note 3

Date expired

(30.11.2014)

CEN

EN ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

16.5.2014

EN ISO 11137-2:2012

Note 2.1

Date expired

(30.11.2014)

CEN

EN ISO 11138-2:2009

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

2.12.2009

EN ISO 11138-2:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11138-3:2009

Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

2.12.2009

EN ISO 11138-3:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11140-1:2009

Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

2.12.2009

EN ISO 11140-1:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11140-3:2009

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

2.12.2009

EN ISO 11140-3:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

2.12.2009

EN ISO 11197:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

2.12.2009

EN ISO 11607-1:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11607-2:2006

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

7.9.2006

CEN

EN ISO 11737-1:2006

Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

7.9.2006

EN 1174-2:1996

EN 1174-1:1996

EN 1174-3:1996

Note 2.1

Date expired

(31.10.2006)

EN ISO 11737-1:2006/AC:2009

2.12.2009

CEN

EN ISO 11737-2:2009

Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

7.7.2010

CEN

EN ISO 11810-1:2009

Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Part 1: Primary ignition and penetration (ISO 11810-1:2005)

2.12.2009

CEN

EN ISO 11810-2:2009

Lasers and laser-related equipment — Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007)

2.12.2009

EN ISO 11810-2:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 11979-8:2009

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006)

2.12.2009

EN ISO 11979-8:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12006-2:1998+A1:2009

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits

2.12.2009

EN 12006-2:1998

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12183:2009

Manual wheelchairs — Requirements and test methods

7.7.2010

CEN

EN 12184:2009

Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods

7.7.2010

CEN

EN 12342:1998+A1:2009

Breathing tubes intended for use with anaesthetic apparatus and ventilators

7.7.2010

EN 12342:1998

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12470-1:2000+A1:2009

Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device

2.12.2009

EN 12470-1:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12470-2:2000+A1:2009

Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers

2.12.2009

EN 12470-2:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 12870:2009

Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004)

2.12.2009

EN ISO 12870:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13060:2004+A2:2010

Small steam sterilizers

7.7.2010

EN 13060:2004+A1:2009

Note 2.1

Date expired

(30.9.2010)

CEN

EN ISO 13408-1:2011

Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

EN ISO 13408-1:2011/A1:2013

16.5.2014

Note 3

Date expired

(30.11.2014)

CEN

EN ISO 13408-2:2011

Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-3:2011

Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-4:2011

Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-5:2011

Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13408-6:2011

Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005)

19.8.2011

EN 13824:2004

Note 2.1

Date expired

(31.12.2011)

CEN

EN ISO 13485:2012

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

30.8.2012

EN ISO 13485:2003

Note 2.1

Date expired

(31.8.2012)

EN ISO 13485:2012/AC:2012

30.8.2012

CEN

EN 13544-1:2007+A1:2009

Respiratory therapy equipment — Part 1: Nebulizing systems and their components

7.7.2010

EN 13544-1:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13544-2:2002+A1:2009

Respiratory therapy equipment — Part 2: Tubing and connectors

7.7.2010

EN 13544-2:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13544-3:2001+A1:2009

Respiratory therapy equipment — Part 3: Air entrainment devices

7.7.2010

EN 13544-3:2001

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13624:2003

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)

30.9.2005

CEN

EN 13718-1:2008

Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances

19.2.2009

EN 13718-1:2002

Note 2.1

Date expired

(28.2.2009)

CEN

EN 13726-1:2002

Test methods for primary wound dressings — Part 1: Aspects of absorbency

27.3.2003

EN 13726-1:2002/AC:2003

2.12.2009

CEN

EN 13726-2:2002

Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings

27.3.2003

CEN

EN 13727:2012

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity in the medical area — Test method and requirements (phase 2, step 1)

30.8.2012

EN 13727:2003

Note 2.1

Date expired

(30.11.2012)

CEN

EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies

2.12.2009

EN 13867:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13976-1:2011

Rescue systems — Transportation of incubators — Part 1: Interface conditions

19.8.2011

EN 13976-1:2003

Note 2.1

Date expired

(30.11.2011)

CEN

EN 13976-2:2011

Rescue systems — Transportation of incubators — Part 2: System requirements

19.8.2011

EN 13976-2:2003

Note 2.1

Date expired

(30.11.2011)

CEN

EN 14079:2003

Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

30.9.2005

CEN

EN 14139:2010

Ophthalmic optics — Specifications for ready-to-wear spectacles

18.1.2011

CEN

EN ISO 14155:2011

Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011)

27.4.2012

EN ISO 14155:2011

Note 2.1

Date expired

(30.4.2012)

CEN

EN 14180:2003+A2:2009

Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing

7.7.2010

EN 14180:2003+A1:2009

Note 2.1

Date expired

(21.3.2010)

CEN

EN 14348:2005

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1)

30.9.2005

CEN

EN ISO 14408:2009

Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005)

2.12.2009

EN ISO 14408:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN 14561:2006

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)

15.11.2006

CEN

EN 14562:2006

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area — Test method and requirements (phase 2, step 2)

15.11.2006

CEN

EN 14563:2008

Chemical disinfectants and antiseptics — Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area — Test method and requirements (phase 2, step 2)

19.2.2009

CEN

EN ISO 14602:2011

Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:2010)

27.4.2012

EN ISO 14602:2010

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 14607:2009

Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)

2.12.2009

EN ISO 14607:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN 14683:2005

Surgical masks — Requirements and test methods

2.6.2006

CEN

EN ISO 14889:2009

Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003)

2.12.2009

EN ISO 14889:2003

Note 2.1

Date expired

(21.3.2010)

CEN

EN 14931:2006

Pressure vessels for human occupancy (PVHO) — Multi-place pressure chamber systems for hyperbaric therapy — Performance, safety requirements and testing

15.11.2006

CEN

EN ISO 14937:2009

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

7.7.2010

EN ISO 14937:2000

Note 2.1

Date expired

(30.4.2010)

CEN

EN ISO 14971:2012

Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30.8.2012

EN ISO 14971:2009

Note 2.1

Date expired

(30.8.2012)

CEN

EN ISO 15001:2011

Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2010)

27.4.2012

EN ISO 15001:2010

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 15002:2008

Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)

19.2.2009

EN 13220:1998

Note 2.1

Date expired

(31.7.2010)

CEN

EN ISO 15004-1:2009

Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

2.12.2009

EN ISO 15004-1:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

27.4.2012

EN ISO 15747:2010

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 15798:2010

Ophthalmic implants — Ophthalmic viscosurgical devices (ISO 15798:2010)

7.7.2010

CEN

EN ISO 15883-1:2009

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

2.12.2009

EN ISO 15883-1:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 15883-2:2009

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

2.12.2009

EN ISO 15883-2:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 15883-3:2009

Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

2.12.2009

EN ISO 15883-3:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 15883-4:2009

Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

2.12.2009

EN ISO 15883-4:2008

Note 2.1

Date expired

(21.3.2010)

CEN

EN 15986:2011

Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates

13.5.2011

CEN

EN ISO 16061:2009

Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008, Corrected version 2009-03-15)

7.7.2010

EN ISO 16061:2008

Note 2.1

Date expired

(28.2.2010)

CEN

EN ISO 16201:2006

Technical aids for disabled persons — Environmental control systems for daily living (ISO 16201:2006)

19.2.2009

CEN

EN ISO 17510-1:2009

Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

2.12.2009

EN ISO 17510-1:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 17510-2:2009

Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007)

2.12.2009

EN ISO 17510-2:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 17664:2004

Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

30.9.2005

CEN

EN ISO 17665-1:2006

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

15.11.2006

EN 554:1994

Note 2.1

Date expired

(31.8.2009)

CEN

EN ISO 18777:2009

Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005)

2.12.2009

EN ISO 18777:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 18778:2009

Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005)

2.12.2009

EN ISO 18778:2005

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005)

30.9.2005

CEN

EN ISO 19054:2006

Rail systems for supporting medical equipment (ISO 19054:2005)

7.9.2006

EN 12218:1998

Note 2.1

Date expired

(30.6.2008)

CEN

EN 20594-1:1993

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986)

18.11.1995

EN 20594-1:1993/A1:1997

10.8.1999

Note 3

Date expired

(31.5.1998)

EN 20594-1:1993/AC:1996

2.12.2009

CEN

EN ISO 21534:2009

Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007)

2.12.2009

EN ISO 21534:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 21535:2009

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007)

2.12.2009

EN ISO 21535:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 21536:2009

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)

2.12.2009

EN ISO 21536:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 21649:2009

Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006)

7.7.2010

EN ISO 21649:2006

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 21969:2009

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

7.7.2010

EN ISO 21969:2006

Note 2.1

Date expired

(31.5.2010)

CEN

EN ISO 21987:2009

Ophthalmic optics — Mounted spectacle lenses (ISO 21987:2009)

7.7.2010

CEN

EN ISO 22442-1:2007

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management (ISO 22442-1:2007)

27.2.2008

EN 12442-1:2000

Note 2.1

Date expired

(30.6.2008)

CEN

EN ISO 22442-2:2007

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

27.2.2008

EN 12442-2:2000

Note 2.1

Date expired

(30.6.2008)

CEN

EN ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

27.2.2008

EN 12442-3:2000

Note 2.1

Date expired

(30.6.2008)

CEN

EN ISO 22523:2006

External limb prostheses and external orthoses — Requirements and test methods (ISO 22523:2006)

9.8.2007

EN 12523:1999

Note 2.1

Date expired

(30.4.2007)

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

CEN

EN ISO 22675:2006

Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods (ISO 22675:2006)

9.8.2007

This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

CEN

EN ISO 23328-1:2008

Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)

19.2.2009

EN 13328-1:2001

Note 2.1

Date expired

(30.9.2008)

CEN

EN ISO 23328-2:2009

Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002)

2.12.2009

EN ISO 23328-2:2008

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 23747:2009

Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

2.12.2009

EN ISO 23747:2007

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 25539-1:2009

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

2.12.2009

EN ISO 25539-1:2008

EN 12006-3:1998+A1:2009

Note 2.1

Date expired

(21.3.2010)

EN ISO 25539-1:2009/AC:2011

30.8.2012

CEN

EN ISO 26782:2009

Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

7.7.2010

EN ISO 26782:2009/AC:2009

7.7.2010

CEN

EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

18.11.1995

EN 27740:1992/A1:1997

10.8.1999

Note 3

Date expired

(31.5.1998)

EN 27740:1992/AC:1996

2.12.2009

CEN

EN ISO 81060-1:2012

Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

30.8.2012

EN 1060-2:1995+A1:2009

EN 1060-1:1995+A2:2009

Note 2.1

Date expired

(31.5.2015)

Cenelec

EN 60118-13:2005

Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)

IEC 60118-13:2004

19.1.2006

EN 60118-13:1997

Note 2.1

Date expired

(1.2.2008)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

IEC 60522:1999

14.11.2001

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60580:2000

Medical electrical equipment — Dose area product meters

IEC 60580:2000

13.12.2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1:2006

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

IEC 60601-1:2005

27.11.2008

EN 60601-1-4:1996

EN 60601-1:1990

EN 60601-1-1:2001

Note 2.1

Date expired

(1.6.2012)

EN 60601-1:2006/AC:2010

18.1.2011

EN 60601-1:2006/A1:2013

IEC 60601-1:2005/A1:2012

16.5.2014

Note 3

Date expired

(31.12.2017)

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.

Cenelec

EN 60601-1-1:2001

Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems

IEC 60601-1-1:2000

14.11.2001

Date expired

(1.11.2003)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-2:2007

Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

IEC 60601-1-2:2007 (Modified)

27.11.2008

EN 60601-1-2:2001

Date expired

(1.6.2012)

EN 60601-1-2:2007/AC:2010

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-3:2008

Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-3:2008

27.11.2008

EN 60601-1-3:1994

Note 2.1

Date expired

(1.6.2012)

EN 60601-1-3:2008/AC:2010

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-4:1996

Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems

IEC 60601-1-4:1996

8.11.1997

EN 60601-1-4:1996/A1:1999

IEC 60601-1-4:1996/A1:1999

8.11.1997

Note 3

Date expired

(1.12.2002)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-6:2010

Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability

IEC 60601-1-6:2010

18.1.2011

EN 60601-1-6:2007

Note 2.1

Date expired

(1.4.2013)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-8:2007

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-8:2006

27.11.2008

EN 60601-1-8:2004

Note 2.1

Date expired

(1.6.2012)

EN 60601-1-8:2007/AC:2010

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-10:2008

Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-10:2007

27.11.2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-11:2010

Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2010

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-1:1998

Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

IEC 60601-2-1:1998

14.11.2001

EN 60601-2-1:1998/A1:2002

IEC 60601-2-1:1998/A1:2002

13.12.2002

Note 3

Date expired

(1.6.2005)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-2:2009

Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-2:2009

7.7.2010

EN 60601-2-2:2007

Note 2.1

Date expired

(1.4.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-3:1993

Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment

IEC 60601-2-3:1991

18.11.1995

EN 60601-2-3:1993/A1:1998

IEC 60601-2-3:1991/A1:1998

18.11.1995

Note 3

Date expired

(1.7.2001)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-4:2003

Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators

IEC 60601-2-4:2002

15.10.2003

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-5:2000

Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

IEC 60601-2-5:2000

13.12.2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-8:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

IEC 60601-2-8:1987

14.11.2001

EN 60601-2-8:1997/A1:1997

IEC 60601-2-8:1987/A1:1997

14.11.2001

Note 3

Date expired

(1.7.1998)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-10:2000

Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

IEC 60601-2-10:1987

13.12.2002

EN 60601-2-10:2000/A1:2001

IEC 60601-2-10:1987/A1:2001

13.12.2002

Note 3

Date expired

(1.11.2004)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-11:1997

Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

IEC 60601-2-11:1997

9.10.1999

EN 60601-2-11:1997/A1:2004

IEC 60601-2-11:1997/A1:2004

9.10.1999

Note 3

Date expired

(1.9.2007)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-12:2006

Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators

IEC 60601-2-12:2001

22.12.2007

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-13:2006

Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

IEC 60601-2-13:2003

22.12.2007

EN 60601-2-13:2006/A1:2007

IEC 60601-2-13:2003/A1:2006

22.12.2007

Note 3

Date expired

(1.3.2010)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-16:1998

Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:1998

9.10.1999

EN 60601-2-16:1998/AC:1999

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-17:2004

Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

IEC 60601-2-17:2004

8.11.2005

Date expired

(1.3.2007)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-18:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment

IEC 60601-2-18:1996

9.10.1999

EN 60601-2-18:1996/A1:2000

IEC 60601-2-18:1996/A1:2000

9.10.1999

Note 3

Date expired

(1.8.2003)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-19:2009

Medical electrical equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

IEC 60601

IEC 60601-2-19:2009

7.7.2010

EN 60601-2-19:1996

Note 2.1

Date expired

(1.4.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-20:2009

Medical electrical equipment — Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC 60601

IEC 60601-2-20:2009

18.1.2011

EN 60601-2-20:1996

Note 2.1

Date expired

(1.9.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-21:2009

Medical electrical equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-21:2009

7.7.2010

EN 60601-2-21:1994

Note 2.1

Date expired

(1.4.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-22:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

IEC 60601-2-22:1995

17.5.1997

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-23:2000

Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

IEC 60601-2-23:1999

14.11.2001

Date expired

(1.1.2003)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-24:1998

Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers

IEC 60601-2-24:1998

9.10.1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-25:1995

Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs

IEC 60601-2-25:1993

17.5.1997

EN 60601-2-25:1995/A1:1999

IEC 60601-2-25:1993/A1:1999

13.12.2002

Note 3

Date expired

(1.5.2002)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-26:2003

Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs

IEC 60601-2-26:2002

8.11.2005

Date expired

(1.3.2006)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-27:2006

Medical electrical equipment — Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

IEC 60601-2-27:2005

26.7.2006

Date expired

(1.11.2008)

EN 60601-2-27:2006/AC:2006

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-28:2010

Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-28:2010

18.1.2011

EN 60601-2-28:1993

Note 2.1

Date expired

(1.4.2013)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-29:2008

Medical electrical equipment — Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

IEC 60601-2-29:2008

15.7.2009

EN 60601-2-29:1999

Note 2.1

Date expired

(1.11.2011)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-34:2000

Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

IEC 60601-2-34:2000

15.10.2003

Date expired

(1.11.2003)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-36:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

IEC 60601-2-36:1997

9.10.1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-37:2008

Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-37:2007

27.11.2008

EN 60601-2-37:2001

Note 2.1

Date expired

(1.10.2010)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-39:2008

Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC 60601-2-39:2007

27.11.2008

EN 60601-2-39:1999

Note 2.1

Date expired

(1.3.2011)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-40:1998

Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

IEC 60601-2-40:1998

9.10.1999

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-41:2009

Medical electrical equipment — Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis

IEC 60601-2-41:2009

18.1.2011

EN 60601-2-41:2000

Note 2.1

Date expired

(1.11.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-43:2010

Medical electrical equipment — Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-43:2010

18.1.2011

EN 60601-2-43:2000

Note 2.1

Date expired

(1.6.2013)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-44:2009

Medical electrical equipment — Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-44:2009

7.7.2010

EN 60601-2-44:2001

Note 2.1

Date expired

(1.5.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-45:2001

Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-45:2001

14.11.2001

EN 60601-2-45:1998

Note 2.1

Date expired

(1.7.2004)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-46:1998

Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables

IEC 60601-2-46:1998

14.11.2001

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-47:2001

Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

IEC 60601-2-47:2001

13.12.2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-49:2001

Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

IEC 60601-2-49:2001

13.12.2002

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-50:2009

Medical electrical equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

IEC 60601-2-50:2009

7.7.2010

EN 60601-2-50:2002

Note 2.1

Date expired

(1.5.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-51:2003

Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

IEC 60601-2-51:2003

24.6.2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-52:2010

Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

13.5.2011

EN 1970:2000

EN 60601-2-38:1996

Date expired

(1.6.2012)

EN 60601-2-52:2010/AC:2011

30.8.2012

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-2-54:2009

Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54:2009

18.1.2011

EN 60601-2-32:1994

EN 60601-2-7:1998

Date expired

(1.8.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60627:2001

Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids

IEC 60627:2001

13.12.2002

EN 60627:2001/AC:2002

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60645-1:2001

Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers

IEC 60645-1:2001

13.12.2002

Date expired

(1.10.2004)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60645-2:1997

Audiometers — Part 2: Equipment for speech audiometry

IEC 60645-2:1993

17.5.1997

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60645-3:2007

Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration

IEC 60645-3:2007

27.11.2008

EN 60645-3:1995

Note 2.1

Date expired

(1.6.2010)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60645-4:1995

Audiometers — Part 4: Equipment for extended high-frequency audiometry

IEC 60645-4:1994

23.8.1996

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 61217:1996

Radiotherapy equipment — Coordinates, movements and scales

IEC 61217:1996

14.11.2001

EN 61217:1996/A1:2001

IEC 61217:1996/A1:2000

14.11.2001

Note 3

Date expired

(1.12.2003)

EN 61217:1996/A2:2008

IEC 61217:1996/A2:2007

27.11.2008

Note 3

Date expired

(1.2.2011)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 61217:2012

Radiotherapy equipment — Coordinates, movements and scales

IEC 61217:2011

30.8.2012

EN 61217:1996

Date expired

(11.1.2015)

Cenelec

EN 61676:2002

Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

IEC 61676:2002

15.10.2003

EN 61676:2002/A1:2009

IEC 61676:2002/A1:2008

7.7.2010

Note 3

Date expired

(1.3.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62083:2009

Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems

IEC 62083:2009

18.1.2011

EN 62083:2001

Note 2.1

Date expired

(1.11.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62220-1:2004

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency

IEC 62220-1:2003

24.6.2004

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62220-1-2:2007

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography

IEC 62220-1-2:2007

27.11.2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62220-1-3:2008

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-3: Determination of the detective quantum efficiency — Detectors used in dynamic imaging

IEC 62220-1-3:2008

15.7.2009

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

IEC 62304:2006

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62366:2008

Medical devices — Application of usability engineering to medical devices

IEC 62366:2007

27.11.2008

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 80601-2-35:2009

Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

IEC 80601

IEC 80601-2-35:2009

18.1.2011

EN 60601-2-35:1996

Note 2.1

Date expired

(1.11.2012)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 80601-2-58:2009

Medical electrical equipment — Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

IEC 80601-2-58:2008

7.7.2010

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 80601-2-59:2009

Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

IEC 80601

IEC 80601-2-59:2008

18.1.2011

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
| --- | --- |

Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
| --- | --- |

—

Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation. |
| --- | --- |

—

References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
| --- | --- |

—

More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu) |
| --- | --- |

—

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

---

| 16.1.2015 | EN | Official Journal of the European Union | C 14/74 |
| --- | --- | --- | --- |

16.1.2015

EN

Official Journal of the European Union

C 14/74

---

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 014/06)

| ESO (1) | Reference and title of the standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | 31.7.2002 | EN 556:1994 + A1:1998
  Note 2.1 | Date expired
  (30.4.2002) |
| | EN 556-1:2001/AC:2006 | 15.11.2006 | | |
| CEN | EN 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | 9.8.2007 | | |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | Date expired
  (31.5.2010) |
| CEN | EN ISO 11137-2:2013
  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | This is the first publication | EN ISO 11137-2:2012
  Note 2.1 | Date expired
  (30.11.2014) |
| CEN | EN ISO 11737-2:2009
  Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) | 7.7.2010 | | |
| CEN | EN 12322:1999
  In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media | 9.10.1999 | | |
| | EN 12322:1999/A1:2001 | 31.7.2002 | Note 3 | Date expired
  (30.4.2002) |
| CEN | EN ISO 13408-1:2011
  Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008) | 19.8.2011 | | |
| | EN ISO 13408-1:2011/A1:2013 | This is the first publication | Note 3 | Date expired
  (30.11.2014) |
| CEN | EN ISO 13408-2:2011
  Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003) | 19.8.2011 | | |
| CEN | EN ISO 13408-3:2011
  Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006) | 19.8.2011 | | |
| CEN | EN ISO 13408-4:2011
  Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005) | 19.8.2011 | | |
| CEN | EN ISO 13408-5:2011
  Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006) | 19.8.2011 | | |
| CEN | EN ISO 13408-6:2011
  Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005) | 19.8.2011 | | |
| CEN | EN ISO 13485:2012
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | 30.8.2012 | EN ISO 13485:2003
  Note 2.1 | Date expired
  (31.8.2012) |
| | EN ISO 13485:2012/AC:2012 | 30.8.2012 | | |
| CEN | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing | 17.12.2002 | | |
| CEN | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices | 17.12.2002 | | |
| | EN 13612:2002/AC:2002 | 2.12.2009 | | |
| CEN | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents | 17.12.2002 | | |
| CEN | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects | 21.11.2003 | | |
| CEN | EN 14136:2004
  Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures | 15.11.2006 | | |
| CEN | EN 14254:2004
  In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans | 28.4.2005 | | |
| CEN | EN 14820:2004
  Single-use containers for human venous blood specimen collection | 28.4.2005 | | |
| CEN | EN ISO 14937:2009
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) | 7.7.2010 | EN ISO 14937:2000
  Note 2.1 | Date expired
  (30.4.2010) |
| CEN | EN ISO 14971:2012
  Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 30.8.2012 | EN ISO 14971:2009
  Note 2.1 | Date expired
  (30.8.2012) |
| CEN | EN ISO 15193:2009
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures (ISO 15193:2009) | 7.7.2010 | | |
| CEN | EN ISO 15194:2009
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) | 7.7.2010 | | |
| CEN | EN ISO 15197:2003
  In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | 28.4.2005 | | |
| | EN ISO 15197:2003/AC:2005 | 2.12.2009 | | |
| CEN | EN ISO 17511:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) | 28.4.2005 | | |
| CEN | EN ISO 18113-1:2011
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) | 27.4.2012 | EN ISO 18113-1:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 18113-2:2011
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) | 27.4.2012 | EN ISO 18113-2:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 18113-3:2011
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) | 27.4.2012 | EN ISO 18113-3:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 18113-4:2011
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) | 27.4.2012 | EN ISO 18113-4:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 18113-5:2011
  In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) | 27.4.2012 | EN ISO 18113-5:2009
  Note 2.1 | Date expired
  (30.4.2012) |
| CEN | EN ISO 18153:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) | 21.11.2003 | | |
| CEN | EN ISO 20776-1:2006
  Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006) | 9.8.2007 | | |
| Cenelec | EN 61010-2-101:2002
  Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
  IEC 61010-2-101:2002 (Modified) | 17.12.2002 | | |
| Cenelec | EN 61326-2-6:2006
  Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment
  IEC 61326-2-6:2005 | 27.11.2008 | | |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| | EN 62304:2006/AC:2008 | 18.1.2011 | | |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  IEC 62366:2007 | 27.11.2008 | | |

ESO (1)

Reference and title of the standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

(1)

(2)

(3)

(4)

(5)

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

31.7.2002

EN 556:1994 + A1:1998

Note 2.1

Date expired

(30.4.2002)

EN 556-1:2001/AC:2006

15.11.2006

CEN

EN 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

9.8.2007

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

Date expired

(31.5.2010)

CEN

EN ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This is the first publication

EN ISO 11137-2:2012

Note 2.1

Date expired

(30.11.2014)

CEN

EN ISO 11737-2:2009

Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

7.7.2010

CEN

EN 12322:1999

In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media

9.10.1999

EN 12322:1999/A1:2001

31.7.2002

Note 3

Date expired

(30.4.2002)

CEN

EN ISO 13408-1:2011

Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008)

19.8.2011

EN ISO 13408-1:2011/A1:2013

This is the first publication

Note 3

Date expired

(30.11.2014)

CEN

EN ISO 13408-2:2011

Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)

19.8.2011

CEN

EN ISO 13408-3:2011

Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006)

19.8.2011

CEN

EN ISO 13408-4:2011

Aseptic processing of health care products — Part 4: Clean-in-place technologies (ISO 13408-4:2005)

19.8.2011

CEN

EN ISO 13408-5:2011

Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006)

19.8.2011

CEN

EN ISO 13408-6:2011

Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005)

19.8.2011

CEN

EN ISO 13485:2012

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

30.8.2012

EN ISO 13485:2003

Note 2.1

Date expired

(31.8.2012)

EN ISO 13485:2012/AC:2012

30.8.2012

CEN

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

17.12.2002

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

17.12.2002

EN 13612:2002/AC:2002

2.12.2009

CEN

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

17.12.2002

CEN

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects

21.11.2003

CEN

EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

15.11.2006

CEN

EN 14254:2004

In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans

28.4.2005

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

28.4.2005

CEN

EN ISO 14937:2009

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

7.7.2010

EN ISO 14937:2000

Note 2.1

Date expired

(30.4.2010)

CEN

EN ISO 14971:2012

Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

30.8.2012

EN ISO 14971:2009

Note 2.1

Date expired

(30.8.2012)

CEN

EN ISO 15193:2009

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

7.7.2010

CEN

EN ISO 15194:2009

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

7.7.2010

CEN

EN ISO 15197:2003

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

28.4.2005

EN ISO 15197:2003/AC:2005

2.12.2009

CEN

EN ISO 17511:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

28.4.2005

CEN

EN ISO 18113-1:2011

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

27.4.2012

EN ISO 18113-1:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 18113-2:2011

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

27.4.2012

EN ISO 18113-2:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 18113-3:2011

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

27.4.2012

EN ISO 18113-3:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 18113-4:2011

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

27.4.2012

EN ISO 18113-4:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 18113-5:2011

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

27.4.2012

EN ISO 18113-5:2009

Note 2.1

Date expired

(30.4.2012)

CEN

EN ISO 18153:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

21.11.2003

CEN

EN ISO 20776-1:2006

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

9.8.2007

Cenelec

EN 61010-2-101:2002

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61010-2-101:2002 (Modified)

17.12.2002

Cenelec

EN 61326-2-6:2006

Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment

IEC 61326-2-6:2005

27.11.2008

Cenelec

EN 62304:2006

Medical device software — Software life-cycle processes

IEC 62304:2006

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

Cenelec

EN 62366:2008

Medical devices — Application of usability engineering to medical devices

IEC 62366:2007

27.11.2008

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
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Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
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Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.2: | The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
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Note 2.2:

The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

| Note 2.3: | The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. |
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Note 2.3:

The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. |
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Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2). |
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Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No1025/2012 (2).

| — | Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. |
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Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also published in French and German). Subsequently, the titles of the standards are translated into all other required official languages of the European Union by the national standardisation bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

| — | References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation. |
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References to Corrigenda ‘.../AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by an European standardisation organisation.

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union. |
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Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the official languages of the European Union.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list. |
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This list replaces all the previous lists published in the Official Journal of the European Union. The European Commission ensures the updating of this list.

| — | More information about harmonised standards and other European standards on the Internet at:
  http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm |
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More information about harmonised standards and other European standards on the Internet at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

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(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu) |
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CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

| — | CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu) |
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CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu) |
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ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. +33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

(2)  OJ L 316, 14.11.2012, p. 12.

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