# Official Journal C 123/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.123.eng |
| --- | --- |
| Official Journal
  of the European Union | C 123 |
| | |
| English edition | Information and Notices | Volume 5527 April 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.123.eng

Official Journal

of the European Union

C 123

English edition

Information and Notices

Volume 5527 April 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 123/01 | Commission communication in the framework of the implementation of the 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 the directive)
   (
  1
  ) | 1 |
| 2012/C 123/02 | 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 the directive)
   (
  1
  ) | 6 |
| 2012/C 123/03 | 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 the directive)
   (
  1
  ) | 31 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 123/01

Commission communication in the framework of the implementation of the 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 the directive)
   (
  1
  )

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

1

1

2012/C 123/02

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 the directive)
   (
  1
  )

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

1

6

2012/C 123/03

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 the directive)
   (
  1
  )

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

1

31

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

---

(1)   Text with EEA relevance

1

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.4.2012 | EN | Official Journal of the European Union | C 123/1 |
| --- | --- | --- | --- |

27.4.2012

EN

Official Journal of the European Union

C 123/1

---

Commission communication in the framework of the implementation of the 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

(Text with EEA relevance)

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

2012/C 123/01

| ESO (1) | Reference and title of the harmonised 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 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 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 10993-12:2009
  Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | 2.12.2009 | EN ISO 10993-12:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| 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) |
| CEN | EN ISO 11137-2:2007
  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) | 9.8.2007 | | |
| EN ISO 11137-2:2007/AC:2009 | 2.12.2009 | | |
| 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) |
| 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 13485:2003
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | 2.4.2004 | EN ISO 13488:2000
  EN ISO 13485:2000
  Note 2.1 | Date expired
  (31.7.2009) |
| EN ISO 13485:2003/AC:2009 | 7.7.2010 | | |
| 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 | 30.4.2012 |
| CEN | EN ISO 14155-1:2009
  Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) | 7.7.2010 | EN ISO 14155-1:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 14155-2:2009
  Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) | 7.7.2010 | EN ISO 14155-2:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 14971:2009
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 7.7.2010 | EN ISO 14971:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 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 | | |
| CEN | EN 45502-2-1:2004
  Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | 24.6.2005 | | |
| CEN | EN 45502-2-3:2010
  Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | 7.7.2010 | | |
| Cenelec | EN 45502-1:1997
  Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer (2) | 27.8.1998 | | |
| 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) (2) | 8.7.2004 | | |
| 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) (2) | 27.11.2008 | | |
| EN 45502-2-2:2008/AC:2009 | 18.1.2011 | | |
| Cenelec | EN 45502-2-3:2010
  Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems (2) | 18.1.2011 | | |
| Cenelec | EN 60601-1:1990
  Medical electrical equipment - Part 1: General requirements for safety
  IEC 60601-1:1988 | 23.8.1996 | | |
| EN 60601-1:1990/A1:1993
  IEC 60601-1:1988/A1:1991 | 23.8.1996 | Note 3 | Date expired
  (7.7.2010) |
| EN 60601-1:1990/A2:1995
  IEC 60601-1:1988/A2:1995 (2) | 23.8.1996 | Note 3 | Date expired
  (7.7.2010) |
| EN 60601-1:1990/AC:1994 | 18.1.2011 | | |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 (2) | 27.11.2008 | EN 60601-1:1990
  and its amendments
  Note 2.1 | 1.6.2012 |
| EN 60601-1:2006/AC:2010 | 18.1.2011 | | |
| 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 (2) | 18.1.2011 | | |
| Cenelec | EN 62304:2006
  Medical device software - Software life-cycle processes
  IEC 62304:2006 (2) | 27.11.2008 | | |
| EN 62304:2006/AC:2008 | 18.1.2011 | | |

ESO (1)

Reference and title of the harmonised 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 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 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 10993-12:2009

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

2.12.2009

EN ISO 10993-12:2007

Note 2.1

Date expired

(21.3.2010)

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)

CEN

EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

9.8.2007

EN ISO 11137-2:2007/AC:2009

2.12.2009

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)

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 13485:2003

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

2.4.2004

EN ISO 13488:2000

EN ISO 13485:2000

Note 2.1

Date expired

(31.7.2009)

EN ISO 13485:2003/AC:2009

7.7.2010

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

30.4.2012

CEN

EN ISO 14155-1:2009

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

7.7.2010

EN ISO 14155-1:2003

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

7.7.2010

EN ISO 14155-2:2003

Note 2.1

Date expired

(21.3.2010)

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 14971:2009

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

7.7.2010

EN ISO 14971:2007

Note 2.1

Date expired

(21.3.2010)

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 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

CEN

EN 45502-2-1:2004

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

24.6.2005

CEN

EN 45502-2-3:2010

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

7.7.2010

Cenelec

EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer (2)

27.8.1998

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) (2)

8.7.2004

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) (2)

27.11.2008

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

18.1.2011

Cenelec

EN 45502-2-3:2010

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

18.1.2011

Cenelec

EN 60601-1:1990

Medical electrical equipment - Part 1: General requirements for safety

IEC 60601-1:1988

23.8.1996

EN 60601-1:1990/A1:1993

IEC 60601-1:1988/A1:1991

23.8.1996

Note 3

Date expired

(7.7.2010)

EN 60601-1:1990/A2:1995

IEC 60601-1:1988/A2:1995 (2)

23.8.1996

Note 3

Date expired

(7.7.2010)

EN 60601-1:1990/AC:1994

18.1.2011

Cenelec

EN 60601-1:2006

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

IEC 60601-1:2005 (2)

27.11.2008

EN 60601-1:1990

and its amendments

Note 2.1

1.6.2012

EN 60601-1:2006/AC:2010

18.1.2011

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 (2)

18.1.2011

Cenelec

EN 62304:2006

Medical device software - Software life-cycle processes

IEC 62304:2006 (2)

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 (column 3) 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 requirements of the directive. |
| --- | --- |

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 (column 3) 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 requirements of the directive.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (3) amended by the Directive 98/48/EC (4). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (3) amended by the Directive 98/48/EC (4).

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

—

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

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

—

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

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

—

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

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

—

More information about harmonised standards on the Internet at

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

---

(1)  ESO: European Standards Organisation:

| — | CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)

| — | Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
| --- | --- |

—

Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu)

| — | ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu)

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

(3)  OJ L 204, 21.7.1998, p. 37.

(4)  OJ L 217, 5.8.1998, p. 18.

---

| 27.4.2012 | EN | Official Journal of the European Union | C 123/6 |
| --- | --- | --- | --- |

27.4.2012

EN

Official Journal of the European Union

C 123/6

---

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

(Text with EEA relevance)

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

2012/C 123/02

| ESO (1) | Reference and title of the harmonised 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
  Medical gloves for single use - Part 2: Requirements and testing for physical properties | 7.7.2010 | EN 455-2:2000
  Note 2.1 | Date expired
  (31.5.2010) |
| 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 794-1:1997+A2:2009
  Lung ventilators - Part 1: Particular requirements for critical care ventilators | 2.12.2009 | EN 794-1:1997
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 1060-1:1995+A2:2009
  Non-invasive sphygmomanometers - Part 1: General requirements | 7.7.2010 | | |
| CEN | EN 1060-2:1995+A1:2009
  Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers | 7.7.2010 | EN 1060-2:1995
  Note 2.1 | Date expired
  (31.5.2010) |
| 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 1089-3:2004
  Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding | 30.9.2005 | EN 1089-3:1997
  Note 2.1 | Date expired
  (31.10.2004) |
| 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 | 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 | This is the first publication | EN 1642:2009
  Note 2.1 | 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 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 5356-2:2007
  Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006) | 9.11.2007 | EN 1281-2:1995
  Note 2.1 | Date expired
  (29.2.2008) |
| 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) |
| 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 7439:2009
  Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002) | 2.12.2009 | EN ISO 7439:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| 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) |
| 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 9919:2009
  Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) | 2.12.2009 | EN ISO 9919:2005
  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 10993-12:2009
  Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | 2.12.2009 | EN ISO 10993-12:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| 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) |
| CEN | EN ISO 11137-2:2007
  Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) | 9.8.2007 | | |
| EN ISO 11137-2:2007/AC:2009 | 2.12.2009 | | |
| 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 ISO 11990:2003
  Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) | 7.11.2003 | EN ISO 11990:1999
  Note 2.1 | Date expired
  (31.10.2003) |
| 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 12006-3:1998+A1:2009
  Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices | 2.12.2009 | EN 12006-3:1998
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12182:1999
  Technical aids for disabled persons - General requirements and test methods | 14.10.2000 | | |
| 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 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 12470-3:2000+A1:2009
  Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | 2.12.2009 | EN 12470-3:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12470-4:2000+A1:2009
  Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement | 2.12.2009 | EN 12470-4:2000
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 12470-5:2003
  Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) | 7.11.2003 | | |
| 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 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) |
| 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 13485:2003
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | 2.4.2004 | EN ISO 13488:2000
  EN ISO 13485:2000
  EN 46003:1999
  Note 2.1 | Date expired
  (31.7.2009) |
| EN ISO 13485:2003/AC:2009 | 7.7.2010 | | |
| 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 13727:2003
  Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) | 30.9.2005 | | |
| CEN | EN 13795-1:2002+A1:2009
  Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products | 7.7.2010 | EN 13795-1:2002
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13795-2:2004+A1:2009
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods | 7.7.2010 | EN 13795-2:2004
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN 13795-3:2006+A1:2009
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels | 7.7.2010 | EN 13795-3:2006
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 | 30.4.2012 |
| CEN | EN ISO 14155-1:2009
  Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) | 7.7.2010 | EN ISO 14155-1:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 14155-2:2009
  Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) | 7.7.2010 | EN ISO 14155-2:2003
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 14160:1998
  Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998) | 27.8.1998 | | |
| 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 ISO 14534:2009
  Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002) | 2.12.2009 | EN ISO 14534:2002
  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 | 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 ISO 14630:2009
  Non-active surgical implants - General requirements (ISO 14630:2008) | 2.12.2009 | EN ISO 14630:2008
  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 14971:2009
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 7.7.2010 | EN ISO 14971:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 | 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 15424:2007
  Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices | 9.8.2007 | | |
| CEN | EN ISO 15747:2011
  Plastic containers for intravenous injections (ISO 15747:2010) | 27.4.2012 | EN ISO 15747:2010
  Note 2.1 | 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 21171:2006
  Medical gloves - Determination of removable surface powder (ISO 21171:2006) | 7.9.2006 | | |
| 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 21647:2009
  Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) | 2.12.2009 | EN ISO 21647:2004
  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 22610:2006
  Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) | 15.11.2006 | | |
| CEN | EN ISO 22612:2005
  Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) | 30.9.2005 | | |
| 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
  Note 2.1 | Date expired
  (21.3.2010) |
| CEN | EN ISO 25539-2:2009
  Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008) | 2.12.2009 | EN ISO 25539-2:2008
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 | | |
| Cenelec | EN 60118-13:2005
  Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
  IEC 60118-13:2004 (2) | 19.1.2006 | EN 60118-13:1997
  Note 2.1 | Date expired
  (1.2.2008) |
| Cenelec | EN 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies
  IEC 60522:1999 (2) | 14.11.2001 | | |
| Cenelec | EN 60580:2000
  Medical electrical equipment - Dose area product meters
  IEC 60580:2000 (2) | 13.12.2002 | | |
| Cenelec | EN 60601-1:1990
  Medical electrical equipment - Part 1: General requirements for safety
  IEC 60601-1:1988 | 18.11.1995 | | |
| EN 60601-1:1990/A1:1993
  IEC 60601-1:1988/A1:1991 | 18.11.1995 | Note 3 | Date expired
  (7.7.2010) |
| EN 60601-1:1990/A2:1995
  IEC 60601-1:1988/A2:1995 (2) | 18.11.1995 | Note 3 | Date expired
  (7.7.2010) |
| EN 60601-1:1990/AC:1994 | 18.1.2011 | | |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 (2) | 27.11.2008 | EN 60601-1:1990
  and its amendments
  - EN 60601-1-1:2001
  - EN 60601-1-4:1996
  and its amendment
  Note 2.1 | 1.6.2012 |
| EN 60601-1:2006/AC:2010 | 18.1.2011 | | |
| 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 (2) | 14.11.2001 | EN 60601-1-1:1993
  - A1:1996
  Note 2.1 | Date expired
  (1.11.2003) |
| Cenelec | EN 60601-1-2:2001
  Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
  IEC 60601-1-2:2001 | 13.12.2002 | EN 60601-1-2:1993
  Note 2.1 | Date expired
  (1.11.2004) |
| EN 60601-1-2:2001/A1:2006
  IEC 60601-1-2:2001/A1:2004 (2) | 22.12.2007 | Note 3 | Date expired
  (1.3.2009) |
| 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) (2) | 27.11.2008 | EN 60601-1-2:2001
  and its amendment
  Note 2.1 | 1.6.2012 |
| EN 60601-1-2:2007/AC:2010 | 18.1.2011 | | |
| Cenelec | EN 60601-1-3:1994
  Medical electrical equipment – Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
  IEC 60601-1-3:1994 (2) | 18.11.1995 | | |
| 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 (2) | 27.11.2008 | EN 60601-1-3:1994
  Note 2.1 | 1.6.2012 |
| EN 60601-1-3:2008/AC:2010 | 18.1.2011 | | |
| 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 (2) | 8.11.1997 | Note 3 | Date expired
  (1.12.2002) |
| Cenelec | EN 60601-1-6:2004
  Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
  IEC 60601-1-6:2004 (2) | 2.7.2006 | | |
| Cenelec | EN 60601-1-6:2007
  Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
  IEC 60601-1-6:2006 (2) | 27.11.2008 | EN 60601-1-6:2004
  Note 2.1 | 1.6.2012 |
| EN 60601-1-6:2007/AC:2010 | 18.1.2011 | | |
| 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 (2) | 18.1.2011 | EN 60601-1-6:2007
  Note 2.1 | 1.4.2013 |
| Cenelec | EN 60601-1-8:2004
  Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  IEC 60601-1-8:2003 | 22.12.2007 | | |
| EN 60601-1-8:2004/A1:2006
  IEC 60601-1-8:2003/A1:2006 (2) | 22.12.2007 | Note 3 | Date expired
  (1.1.2007) |
| 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 (2) | 27.11.2008 | EN 60601-1-8:2004
  and its amendment
  Note 2.1 | 1.6.2012 |
| EN 60601-1-8:2007/AC:2010 | 18.1.2011 | | |
| 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 (2) | 27.11.2008 | | |
| 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 (2) | 18.1.2011 | | |
| 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 (2) | 13.12.2002 | Note 3 | Date expired
  (1.6.2005) |
| Cenelec | EN 60601-2-2:2007
  Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
  IEC 60601-2-2:2006 (2) | 22.12.2007 | EN 60601-2-2:2000
  Note 2.1 | Date expired
  (1.10.2009) |
| 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 (2) | 7.7.2010 | EN 60601-2-2:2007
  Note 2.1 | Date expired
  (1.4.2012) |
| 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 (2) | 18.11.1995 | Note 3 | Date expired
  (1.7.2001) |
| 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 (2) | 15.10.2003 | | |
| 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 (2) | 13.12.2002 | | |
| Cenelec | EN 60601-2-7:1998
  Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
  IEC 60601-2-7:1998 (2) | 9.10.1999 | | |
| 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 (2) | 14.11.2001 | Note 3 | Date expired
  (1.7.1998) |
| 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 (2) | 13.12.2002 | Note 3 | Date expired
  (1.11.2004) |
| 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 (2) | 9.10.1999 | Note 3 | Date expired
  (1.9.2007) |
| 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 (2) | 22.12.2007 | | |
| 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 (2) | 22.12.2007 | Note 3 | Date expired
  (1.3.2010) |
| 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 (2) | 9.10.1999 | | |
| EN 60601-2-16:1998/AC:1999 | 18.1.2011 | | |
| 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 (2) | 8.11.2005 | EN 60601-2-17:1996
  - A1:1996
  Note 2.1 | Date expired
  (1.3.2007) |
| 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 (2) | 9.10.1999 | Note 3 | Date expired
  (1.8.2003) |
| Cenelec | EN 60601-2-19:1996
  Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators
  IEC 60601-2-19:1990 | 9.10.1999 | | |
| EN 60601-2-19:1996/A1:1996
  IEC 60601-2-19:1990/A1:1996 (2) | 9.10.1999 | Note 3 | Date expired
  (13.6.1998) |
| 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 60601-2-19:2009 (2) | 7.7.2010 | EN 60601-2-19:1996
  and its amendment
  Note 2.1 | Date expired
  (1.4.2012) |
| Cenelec | EN 60601-2-20:1996
  Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators
  IEC 60601-2-20:1990 + A1:1996 (2) | 9.10.1999 | | |
| 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 60601-2-20:2009 (2) | 18.1.2011 | EN 60601-2-20:1996
  Note 2.1 | 1.9.2012 |
| Cenelec | EN 60601-2-21:1994
  Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers
  IEC 60601-2-21:1994 | 18.11.1995 | | |
| EN 60601-2-21:1994/A1:1996
  IEC 60601-2-21:1994/A1:1996 (2) | 23.8.2006 | Note 3 | Date expired
  (13.6.1998) |
| 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 (2) | 7.7.2010 | EN 60601-2-21:1994
  and its amendment
  Note 2.1 | Date expired
  (1.4.2012) |
| 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 (2) | 17.5.1997 | | |
| 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 (2) | 14.11.2001 | EN 60601-2-23:1997
  Note 2.1 | Date expired
  (1.1.2003) |
| 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 (2) | 9.10.1999 | | |
| 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 (2) | 13.12.2002 | Note 3 | Date expired
  (1.5.2002) |
| Cenelec | EN 60601-2-26:2003
  Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
  IEC 60601-2-26:2002 (2) | 8.11.2005 | EN 60601-2-26:1994
  Note 2.1 | Date expired
  (1.3.2006) |
| 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 (2) | 26.7.2006 | EN 60601-2-27:1994
  Note 2.1 | Date expired
  (1.11.2008) |
| EN 60601-2-27:2006/AC:2006 | 18.1.2011 | | |
| Cenelec | EN 60601-2-28:1993
  Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
  IEC 60601-2-28:1993 (2) | 18.11.1995 | | |
| 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 (2) | 18.1.2011 | EN 60601-2-28:1993
  Note 2.1 | 1.4.2013 |
| Cenelec | EN 60601-2-29:1999
  Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
  IEC 60601-2-29:1999 (2) | 9.10.1999 | EN 60601-2-29:1995
  - A1:1996
  Note 2.1 | Date expired
  (1.4.2002) |
| 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 (2) | 15.7.2009 | EN 60601-2-29:1999
  Note 2.1 | Date expired
  (1.11.2011) |
| Cenelec | EN 60601-2-30:2000
  Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
  IEC 60601-2-30:1999 (2) | 14.11.2001 | EN 60601-2-30:1995
  Note 2.1 | Date expired
  (1.2.2003) |
| Cenelec | EN 60601-2-31:1995
  Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
  IEC 60601-2-31:1994 | 18.11.1995 | | |
| EN 60601-2-31:1995/A1:1998
  IEC 60601-2-31:1994/A1:1998 (2) | 14.11.2001 | Note 3 | Date expired
  (1.1.2001) |
| Cenelec | EN 60601-2-32:1994
  Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
  IEC 60601-2-32:1994 (2) | 18.11.1995 | | |
| Cenelec | EN 60601-2-33:2002
  Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  IEC 60601-2-33:2002 | 15.10.2003 | EN 60601-2-33:1995
  - A11:1997
  Note 2.1 | Date expired
  (1.7.2005) |
| EN 60601-2-33:2002/A1:2005
  IEC 60601-2-33:2002/A1:2005 | 27.7.2006 | Note 3 | Date expired
  (1.11.2008) |
| EN 60601-2-33:2002/A2:2008
  IEC 60601-2-33:2002/A2:2007 (2) | 27.11.2008 | Note 3 | Date expired
  (1.2.2011) |
| 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 (2) | 15.10.2003 | EN 60601-2-34:1995
  Note 2.1 | Date expired
  (1.11.2003) |
| Cenelec | EN 60601-2-35:1996
  Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
  IEC 60601-2-35:1996 (2) | 9.10.1999 | | |
| 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 (2) | 27.11.2008 | EN 60601-2-37:2001
  - A1:2005
  - A2:2005
  Note 2.1 | Date expired
  (1.10.2010) |
| 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 (2) | 9.10.1999 | | |
| 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 (2) | 27.11.2008 | EN 60601-2-39:1999
  Note 2.1 | Date expired
  (1.3.2011) |
| Cenelec | EN 60601-2-38:1996
  Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
  IEC 60601-2-38:1996 | 9.10.1999 | | |
| EN 60601-2-38:1996/A1:2000
  IEC 60601-2-38:1996/A1:1999 (2) | 14.11.2001 | Note 3 | Date expired
  (1.1.2003) |
| Cenelec | EN 60601-2-39:1999
  Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
  IEC 60601-2-39:1999 (2) | 14.11.2001 | | |
| EN 60601-2-39:1999/AC:1999 | 18.1.2011 | | |
| 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 (2) | 18.1.2011 | EN 60601-2-41:2000
  Note 2.1 | 1.11.2012 |
| 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 (2) | 9.10.1999 | | |
| Cenelec | EN 60601-2-41:2000
  Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
  IEC 60601-2-41:2000 (2) | 14.11.2001 | | |
| Cenelec | EN 60601-2-43:2000
  Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
  IEC 60601-2-43:2000 (2) | 13.12.2002 | | |
| 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 (2) | 7.7.2010 | EN 60601-2-44:2001
  and its amendment
  Note 2.1 | 1.5.2012 |
| 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 (2) | 18.1.2011 | EN 60601-2-43:2000
  Note 2.1 | 1.6.2013 |
| Cenelec | EN 60601-2-44:2001
  Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
  IEC 60601-2-44:2001 | 14.11.2001 | EN 60601-2-44:1999
  Note 2.1 | Date expired
  (1.7.2004) |
| EN 60601-2-44:2001/A1:2003
  IEC 60601-2-44:2001/A1:2002 (2) | 8.11.2005 | Note 3 | Date expired
  (1.12.2005) |
| 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 (2) | 14.11.2001 | EN 60601-2-45:1998
  Note 2.1 | Date expired
  (1.7.2004) |
| 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 (2) | 14.11.2001 | | |
| 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 (2) | 13.12.2002 | | |
| 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 (2) | 7.7.2010 | EN 60601-2-50:2002
  Note 2.1 | 1.5.2012 |
| 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 (2) | 13.12.2002 | | |
| Cenelec | EN 60601-2-50:2002
  Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
  IEC 60601-2-50:2000 (2) | 13.12.2002 | | |
| 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 (2) | 24.6.2004 | | |
| 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 (2) | 13.5.2011 | EN 60601-2-38:1996
  and its amendment
  - EN 1970:2000 | 1.4.2013 |
| 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 (2) | 18.1.2011 | EN 60601-2-7:1998
  - EN 60601-2-28:1993
  - EN 60601-2-32:1994
  Note 2.1 | 1.8.2012 |
| Cenelec | EN 60627:2001
  Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
  IEC 60627:2001 (2) | 13.12.2002 | | |
| EN 60627:2001/AC:2002 | 18.1.2011 | | |
| Cenelec | EN 60645-1:2001
  Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
  IEC 60645-1:2001 (2) | 13.12.2002 | EN 60645-1:1994
  Note 2.1 | Date expired
  (1.10.2004) |
| Cenelec | EN 60645-2:1997
  Audiometers - Part 2: Equipment for speech audiometry
  IEC 60645-2:1993 (2) | 17.5.1997 | | |
| Cenelec | EN 60645-3:2007
  Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
  IEC 60645-3:2007 (2) | 27.11.2008 | EN 60645-3:1995
  Note 2.1 | Date expired
  (1.6.2010) |
| Cenelec | EN 60645-4:1995
  Audiometers - Part 4: Equipment for extended high-frequency audiometry
  IEC 60645-4:1994 (2) | 23.8.1996 | | |
| 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 (2) | 27.11.2008 | Note 3 | Date expired
  (1.2.2011) |
| 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 (2) | 7.7.2010 | Note 3 | Date expired
  (1.3.2012) |
| Cenelec | EN 62083:2001
  Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
  IEC 62083:2000 (2) | 13.12.2002 | | |
| Cenelec | EN 62083:2009
  Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
  IEC 62083:2009 (2) | 18.1.2011 | EN 62083:2001
  Note 2.1 | 1.11.2012 |
| 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 (2) | 24.6.2004 | | |
| 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 (2) | 27.11.2008 | | |
| 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 (2) | 15.7.2009 | | |
| Cenelec | EN 62304:2006
  Medical device software - Software life-cycle processes
  IEC 62304:2006 (2) | 27.11.2008 | | |
| EN 62304:2006/AC:2008 | 18.1.2011 | | |
| 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 80601-2-35:2009 (2) | 18.1.2011 | EN 60601-2-35:1996
  Note 2.1 | 1.11.2012 |
| Cenelec | EN 62366:2008
  Medical devices - Application of usability engineering to medical devices
  IEC 62366:2007 (2) | 27.11.2008 | | |
| 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 (2) | 7.7.2010 | | |
| 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 80601-2-59:2008 (2) | 18.1.2011 | | |

ESO (1)

Reference and title of the harmonised 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

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

7.7.2010

EN 455-2:2000

Note 2.1

Date expired

(31.5.2010)

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 794-1:1997+A2:2009

Lung ventilators - Part 1: Particular requirements for critical care ventilators

2.12.2009

EN 794-1:1997

Note 2.1

Date expired

(21.3.2010)

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 1060-1:1995+A2:2009

Non-invasive sphygmomanometers - Part 1: General requirements

7.7.2010

CEN

EN 1060-2:1995+A1:2009

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

7.7.2010

EN 1060-2:1995

Note 2.1

Date expired

(31.5.2010)

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 1089-3:2004

Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding

30.9.2005

EN 1089-3:1997

Note 2.1

Date expired

(31.10.2004)

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

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

This is the first publication

EN 1642:2009

Note 2.1

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 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 5356-2:2007

Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

9.11.2007

EN 1281-2:1995

Note 2.1

Date expired

(29.2.2008)

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)

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 7439:2009

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)

2.12.2009

EN ISO 7439:2002

Note 2.1

Date expired

(21.3.2010)

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)

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 9919:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

2.12.2009

EN ISO 9919:2005

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 10993-12:2009

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

2.12.2009

EN ISO 10993-12:2007

Note 2.1

Date expired

(21.3.2010)

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)

CEN

EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

9.8.2007

EN ISO 11137-2:2007/AC:2009

2.12.2009

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 ISO 11990:2003

Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

7.11.2003

EN ISO 11990:1999

Note 2.1

Date expired

(31.10.2003)

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 12006-3:1998+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

2.12.2009

EN 12006-3:1998

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12182:1999

Technical aids for disabled persons - General requirements and test methods

14.10.2000

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 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 12470-3:2000+A1:2009

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

2.12.2009

EN 12470-3:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12470-4:2000+A1:2009

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

2.12.2009

EN 12470-4:2000

Note 2.1

Date expired

(21.3.2010)

CEN

EN 12470-5:2003

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

7.11.2003

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 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)

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 13485:2003

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

2.4.2004

EN ISO 13488:2000

EN ISO 13485:2000

EN 46003:1999

Note 2.1

Date expired

(31.7.2009)

EN ISO 13485:2003/AC:2009

7.7.2010

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 13727:2003

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

30.9.2005

CEN

EN 13795-1:2002+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products

7.7.2010

EN 13795-1:2002

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13795-2:2004+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

7.7.2010

EN 13795-2:2004

Note 2.1

Date expired

(21.3.2010)

CEN

EN 13795-3:2006+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

7.7.2010

EN 13795-3:2006

Note 2.1

Date expired

(21.3.2010)

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

30.4.2012

CEN

EN ISO 14155-1:2009

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

7.7.2010

EN ISO 14155-1:2003

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

7.7.2010

EN ISO 14155-2:2003

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 14160:1998

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

27.8.1998

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 ISO 14534:2009

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)

2.12.2009

EN ISO 14534:2002

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

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 ISO 14630:2009

Non-active surgical implants - General requirements (ISO 14630:2008)

2.12.2009

EN ISO 14630:2008

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 14971:2009

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

7.7.2010

EN ISO 14971:2007

Note 2.1

Date expired

(21.3.2010)

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

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 15424:2007

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

9.8.2007

CEN

EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

27.4.2012

EN ISO 15747:2010

Note 2.1

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 21171:2006

Medical gloves - Determination of removable surface powder (ISO 21171:2006)

7.9.2006

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 21647:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)

2.12.2009

EN ISO 21647:2004

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 22610:2006

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)

15.11.2006

CEN

EN ISO 22612:2005

Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)

30.9.2005

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

Note 2.1

Date expired

(21.3.2010)

CEN

EN ISO 25539-2:2009

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

2.12.2009

EN ISO 25539-2:2008

Note 2.1

Date expired

(21.3.2010)

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

Cenelec

EN 60118-13:2005

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

IEC 60118-13:2004 (2)

19.1.2006

EN 60118-13:1997

Note 2.1

Date expired

(1.2.2008)

Cenelec

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

IEC 60522:1999 (2)

14.11.2001

Cenelec

EN 60580:2000

Medical electrical equipment - Dose area product meters

IEC 60580:2000 (2)

13.12.2002

Cenelec

EN 60601-1:1990

Medical electrical equipment - Part 1: General requirements for safety

IEC 60601-1:1988

18.11.1995

EN 60601-1:1990/A1:1993

IEC 60601-1:1988/A1:1991

18.11.1995

Note 3

Date expired

(7.7.2010)

EN 60601-1:1990/A2:1995

IEC 60601-1:1988/A2:1995 (2)

18.11.1995

Note 3

Date expired

(7.7.2010)

EN 60601-1:1990/AC:1994

18.1.2011

Cenelec

EN 60601-1:2006

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

IEC 60601-1:2005 (2)

27.11.2008

EN 60601-1:1990

and its amendments

- EN 60601-1-1:2001

- EN 60601-1-4:1996

and its amendment

Note 2.1

1.6.2012

EN 60601-1:2006/AC:2010

18.1.2011

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 (2)

14.11.2001

EN 60601-1-1:1993

- A1:1996

Note 2.1

Date expired

(1.11.2003)

Cenelec

EN 60601-1-2:2001

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

IEC 60601-1-2:2001

13.12.2002

EN 60601-1-2:1993

Note 2.1

Date expired

(1.11.2004)

EN 60601-1-2:2001/A1:2006

IEC 60601-1-2:2001/A1:2004 (2)

22.12.2007

Note 3

Date expired

(1.3.2009)

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) (2)

27.11.2008

EN 60601-1-2:2001

and its amendment

Note 2.1

1.6.2012

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

18.1.2011

Cenelec

EN 60601-1-3:1994

Medical electrical equipment – Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

IEC 60601-1-3:1994 (2)

18.11.1995

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 (2)

27.11.2008

EN 60601-1-3:1994

Note 2.1

1.6.2012

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

18.1.2011

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 (2)

8.11.1997

Note 3

Date expired

(1.12.2002)

Cenelec

EN 60601-1-6:2004

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

IEC 60601-1-6:2004 (2)

2.7.2006

Cenelec

EN 60601-1-6:2007

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

IEC 60601-1-6:2006 (2)

27.11.2008

EN 60601-1-6:2004

Note 2.1

1.6.2012

EN 60601-1-6:2007/AC:2010

18.1.2011

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 (2)

18.1.2011

EN 60601-1-6:2007

Note 2.1

1.4.2013

Cenelec

EN 60601-1-8:2004

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-8:2003

22.12.2007

EN 60601-1-8:2004/A1:2006

IEC 60601-1-8:2003/A1:2006 (2)

22.12.2007

Note 3

Date expired

(1.1.2007)

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 (2)

27.11.2008

EN 60601-1-8:2004

and its amendment

Note 2.1

1.6.2012

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

18.1.2011

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 (2)

27.11.2008

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 (2)

18.1.2011

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 (2)

13.12.2002

Note 3

Date expired

(1.6.2005)

Cenelec

EN 60601-2-2:2007

Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

IEC 60601-2-2:2006 (2)

22.12.2007

EN 60601-2-2:2000

Note 2.1

Date expired

(1.10.2009)

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 (2)

7.7.2010

EN 60601-2-2:2007

Note 2.1

Date expired

(1.4.2012)

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 (2)

18.11.1995

Note 3

Date expired

(1.7.2001)

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 (2)

15.10.2003

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 (2)

13.12.2002

Cenelec

EN 60601-2-7:1998

Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

IEC 60601-2-7:1998 (2)

9.10.1999

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 (2)

14.11.2001

Note 3

Date expired

(1.7.1998)

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 (2)

13.12.2002

Note 3

Date expired

(1.11.2004)

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 (2)

9.10.1999

Note 3

Date expired

(1.9.2007)

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 (2)

22.12.2007

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 (2)

22.12.2007

Note 3

Date expired

(1.3.2010)

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 (2)

9.10.1999

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

18.1.2011

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 (2)

8.11.2005

EN 60601-2-17:1996

- A1:1996

Note 2.1

Date expired

(1.3.2007)

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 (2)

9.10.1999

Note 3

Date expired

(1.8.2003)

Cenelec

EN 60601-2-19:1996

Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators

IEC 60601-2-19:1990

9.10.1999

EN 60601-2-19:1996/A1:1996

IEC 60601-2-19:1990/A1:1996 (2)

9.10.1999

Note 3

Date expired

(13.6.1998)

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 60601-2-19:2009 (2)

7.7.2010

EN 60601-2-19:1996

and its amendment

Note 2.1

Date expired

(1.4.2012)

Cenelec

EN 60601-2-20:1996

Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators

IEC 60601-2-20:1990 + A1:1996 (2)

9.10.1999

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 60601-2-20:2009 (2)

18.1.2011

EN 60601-2-20:1996

Note 2.1

1.9.2012

Cenelec

EN 60601-2-21:1994

Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers

IEC 60601-2-21:1994

18.11.1995

EN 60601-2-21:1994/A1:1996

IEC 60601-2-21:1994/A1:1996 (2)

23.8.2006

Note 3

Date expired

(13.6.1998)

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 (2)

7.7.2010

EN 60601-2-21:1994

and its amendment

Note 2.1

Date expired

(1.4.2012)

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 (2)

17.5.1997

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 (2)

14.11.2001

EN 60601-2-23:1997

Note 2.1

Date expired

(1.1.2003)

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 (2)

9.10.1999

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 (2)

13.12.2002

Note 3

Date expired

(1.5.2002)

Cenelec

EN 60601-2-26:2003

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

IEC 60601-2-26:2002 (2)

8.11.2005

EN 60601-2-26:1994

Note 2.1

Date expired

(1.3.2006)

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 (2)

26.7.2006

EN 60601-2-27:1994

Note 2.1

Date expired

(1.11.2008)

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

18.1.2011

Cenelec

EN 60601-2-28:1993

Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60601-2-28:1993 (2)

18.11.1995

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 (2)

18.1.2011

EN 60601-2-28:1993

Note 2.1

1.4.2013

Cenelec

EN 60601-2-29:1999

Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators

IEC 60601-2-29:1999 (2)

9.10.1999

EN 60601-2-29:1995

- A1:1996

Note 2.1

Date expired

(1.4.2002)

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 (2)

15.7.2009

EN 60601-2-29:1999

Note 2.1

Date expired

(1.11.2011)

Cenelec

EN 60601-2-30:2000

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

IEC 60601-2-30:1999 (2)

14.11.2001

EN 60601-2-30:1995

Note 2.1

Date expired

(1.2.2003)

Cenelec

EN 60601-2-31:1995

Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

IEC 60601-2-31:1994

18.11.1995

EN 60601-2-31:1995/A1:1998

IEC 60601-2-31:1994/A1:1998 (2)

14.11.2001

Note 3

Date expired

(1.1.2001)

Cenelec

EN 60601-2-32:1994

Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

IEC 60601-2-32:1994 (2)

18.11.1995

Cenelec

EN 60601-2-33:2002

Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

IEC 60601-2-33:2002

15.10.2003

EN 60601-2-33:1995

- A11:1997

Note 2.1

Date expired

(1.7.2005)

EN 60601-2-33:2002/A1:2005

IEC 60601-2-33:2002/A1:2005

27.7.2006

Note 3

Date expired

(1.11.2008)

EN 60601-2-33:2002/A2:2008

IEC 60601-2-33:2002/A2:2007 (2)

27.11.2008

Note 3

Date expired

(1.2.2011)

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 (2)

15.10.2003

EN 60601-2-34:1995

Note 2.1

Date expired

(1.11.2003)

Cenelec

EN 60601-2-35:1996

Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

IEC 60601-2-35:1996 (2)

9.10.1999

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 (2)

27.11.2008

EN 60601-2-37:2001

- A1:2005

- A2:2005

Note 2.1

Date expired

(1.10.2010)

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 (2)

9.10.1999

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 (2)

27.11.2008

EN 60601-2-39:1999

Note 2.1

Date expired

(1.3.2011)

Cenelec

EN 60601-2-38:1996

Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

IEC 60601-2-38:1996

9.10.1999

EN 60601-2-38:1996/A1:2000

IEC 60601-2-38:1996/A1:1999 (2)

14.11.2001

Note 3

Date expired

(1.1.2003)

Cenelec

EN 60601-2-39:1999

Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

IEC 60601-2-39:1999 (2)

14.11.2001

EN 60601-2-39:1999/AC:1999

18.1.2011

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 (2)

18.1.2011

EN 60601-2-41:2000

Note 2.1

1.11.2012

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 (2)

9.10.1999

Cenelec

EN 60601-2-41:2000

Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

IEC 60601-2-41:2000 (2)

14.11.2001

Cenelec

EN 60601-2-43:2000

Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

IEC 60601-2-43:2000 (2)

13.12.2002

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 (2)

7.7.2010

EN 60601-2-44:2001

and its amendment

Note 2.1

1.5.2012

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 (2)

18.1.2011

EN 60601-2-43:2000

Note 2.1

1.6.2013

Cenelec

EN 60601-2-44:2001

Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

IEC 60601-2-44:2001

14.11.2001

EN 60601-2-44:1999

Note 2.1

Date expired

(1.7.2004)

EN 60601-2-44:2001/A1:2003

IEC 60601-2-44:2001/A1:2002 (2)

8.11.2005

Note 3

Date expired

(1.12.2005)

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 (2)

14.11.2001

EN 60601-2-45:1998

Note 2.1

Date expired

(1.7.2004)

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 (2)

14.11.2001

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 (2)

13.12.2002

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 (2)

7.7.2010

EN 60601-2-50:2002

Note 2.1

1.5.2012

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 (2)

13.12.2002

Cenelec

EN 60601-2-50:2002

Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment

IEC 60601-2-50:2000 (2)

13.12.2002

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 (2)

24.6.2004

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 (2)

13.5.2011

EN 60601-2-38:1996

and its amendment

- EN 1970:2000

1.4.2013

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 (2)

18.1.2011

EN 60601-2-7:1998

- EN 60601-2-28:1993

- EN 60601-2-32:1994

Note 2.1

1.8.2012

Cenelec

EN 60627:2001

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

IEC 60627:2001 (2)

13.12.2002

EN 60627:2001/AC:2002

18.1.2011

Cenelec

EN 60645-1:2001

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers

IEC 60645-1:2001 (2)

13.12.2002

EN 60645-1:1994

Note 2.1

Date expired

(1.10.2004)

Cenelec

EN 60645-2:1997

Audiometers - Part 2: Equipment for speech audiometry

IEC 60645-2:1993 (2)

17.5.1997

Cenelec

EN 60645-3:2007

Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration

IEC 60645-3:2007 (2)

27.11.2008

EN 60645-3:1995

Note 2.1

Date expired

(1.6.2010)

Cenelec

EN 60645-4:1995

Audiometers - Part 4: Equipment for extended high-frequency audiometry

IEC 60645-4:1994 (2)

23.8.1996

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 (2)

27.11.2008

Note 3

Date expired

(1.2.2011)

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 (2)

7.7.2010

Note 3

Date expired

(1.3.2012)

Cenelec

EN 62083:2001

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

IEC 62083:2000 (2)

13.12.2002

Cenelec

EN 62083:2009

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

IEC 62083:2009 (2)

18.1.2011

EN 62083:2001

Note 2.1

1.11.2012

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 (2)

24.6.2004

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 (2)

27.11.2008

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 (2)

15.7.2009

Cenelec

EN 62304:2006

Medical device software - Software life-cycle processes

IEC 62304:2006 (2)

27.11.2008

EN 62304:2006/AC:2008

18.1.2011

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 80601-2-35:2009 (2)

18.1.2011

EN 60601-2-35:1996

Note 2.1

1.11.2012

Cenelec

EN 62366:2008

Medical devices - Application of usability engineering to medical devices

IEC 62366:2007 (2)

27.11.2008

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 (2)

7.7.2010

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 80601-2-59:2008 (2)

18.1.2011

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 (column 3) 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 requirements of the directive. |
| --- | --- |

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 (column 3) 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 requirements of the directive.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (3) amended by the Directive 98/48/EC (4). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (3) amended by the Directive 98/48/EC (4).

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

—

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

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

—

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

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

—

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

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

—

More information about harmonised standards on the Internet at

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

---

(1)  ESO: European Standards Organisation:

| — | CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)

| — | Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
| --- | --- |

—

Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu)

| — | ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu)

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

(3)  OJ L 204, 21.7.1998, p. 37.

(4)  OJ L 217, 5.8.1998, p. 18.

---

| 27.4.2012 | EN | Official Journal of the European Union | C 123/31 |
| --- | --- | --- | --- |

27.4.2012

EN

Official Journal of the European Union

C 123/31

---

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

(Text with EEA relevance)

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

2012/C 123/03

| ESO (1) | Reference and title of the harmonised 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 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 | | |
| 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 13485:2003
  Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | 2.4.2004 | EN ISO 13488:2000
  EN ISO 13485:2000
  Note 2.1 | Date expired
  (31.7.2009) |
| EN ISO 13485:2003/AC:2009 | 7.7.2010 | | |
| 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 13640:2002
  Stability testing of in vitro diagnostic reagents | 17.12.2002 | | |
| 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 14971:2009
  Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | 7.7.2010 | EN ISO 14971:2007
  Note 2.1 | Date expired
  (21.3.2010) |
| 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 | 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 | 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 | 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 | 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 | 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 harmonised 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 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

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 13485:2003

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

2.4.2004

EN ISO 13488:2000

EN ISO 13485:2000

Note 2.1

Date expired

(31.7.2009)

EN ISO 13485:2003/AC:2009

7.7.2010

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 13640:2002

Stability testing of in vitro diagnostic reagents

17.12.2002

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 14971:2009

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

7.7.2010

EN ISO 14971:2007

Note 2.1

Date expired

(21.3.2010)

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

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

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

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

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

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. |
| --- | --- |

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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive. |
| --- | --- |

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 requirements of the directive.

| 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products 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 (column 3) 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 requirements of the directive. |
| --- | --- |

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 (column 3) 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 requirements of the directive.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council (2) amended by the Directive 98/48/EC (3).

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

—

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

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

—

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

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

—

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

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

—

More information about harmonised standards on the Internet at

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

---

(1)  ESO: European Standards Organisation:

| — | CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)

| — | Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
| --- | --- |

—

Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; fax +32 25196919 (http://www.cenelec.eu)

| — | ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; fax +33 493654716 (http://www.etsi.eu)

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

---