# Official Journal C 293/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.293.eng |
| --- | --- |
| Official Journal
  of the European Union | C 293 |
| | |
| English edition | Information and Notices | Volume 522 December 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.293.eng

Official Journal

of the European Union

C 293

English edition

Information and Notices

Volume 522 December 2009

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 293/01 | Commission communication in the framework of the implementation of Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity(Publication of titles and references of harmonised standards under the Directive)
   (
  1
  ) | 1 |
| 2009/C 293/02 | Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(Publication of titles and references of harmonised standards under the Directive)
   (
  1
  ) | 34 |
| 2009/C 293/03 | Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(Publication of titles and references of harmonised standards under the Directive)
   (
  1
  ) | 39 |
| 2009/C 293/04 | Commission communication in the framework of the implementation of 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
  ) | 69 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 293/01

Commission communication in the framework of the implementation of Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity(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

2009/C 293/02

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

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

1

34

2009/C 293/03

Commission communication in the framework of the implementation of 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

39

2009/C 293/04

Commission communication in the framework of the implementation of 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

69

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| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 2.12.2009 | EN | Official Journal of the European Union | C 293/1 |
| --- | --- | --- | --- |

2.12.2009

EN

Official Journal of the European Union

C 293/1

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Commission communication in the framework of the implementation of Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity

(Text with EEA relevance)

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

2009/C 293/01

| European Standards Organisation (1) | Reference and title of the standard
  (and reference document) | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  Note 1 | Article 1999/5/EC |
| --- | --- | --- | --- | --- |
| Cenelec | EN 41003:1998 | | | |
| Particular safety requirements for equipment to be connected to telecommunication networks | EN 41003:1996
  Note 2.1 | Date expired
  (1.1.2002) | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 50360:2001 | | | |
| Product standard to demonstrate the compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields (300 MHz — 3 GHz) | None | — | Article 3(1)(a) |
| Cenelec | EN 50364:2001 | | | |
| Limitation of human exposure to electromagnetic fields from devices operating in the frequency range 0 Hz to 10 GHz, used in electronic article surveillance (EAS), radio frequency identification (RFID) and similar applications | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 50371:2002 | | | |
| Generic standard to demonstrate the compliance of low power electronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields (10 MHz — 300 GHz) — General public | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 50385:2002 | | | |
| Product standard to demonstrate the compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions or the reference levels related to human exposure to radio frequency electromagnetic fields (110 MHz — 40 GHz) — General public | None | — | Article 3(1)(a) |
| Cenelec | EN 50401:2006 | | | |
| Product standard to demonstrate the compliance of fixed equipment for radio transmission (110 MHz — 40 GHz) intended for use in wireless telecommunication networks with the basic restrictions or the reference levels related to general public exposure to radio frequency electromagnetic fields, when put into service | None | — | Article 3(1)(a) |
| Cenelec | EN 55022:1998 | | | |
| Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement
  (CISPR 22:1997 (modified)) | EN 55022:1994
  - A1:1995
  - A2:1997
  Note 2.1 | Date expired
  (1.8.2007) | Article 3(1)(b) |
| Amendment A1:2000 to EN 55022:1998
  (CISPR 22:1997/A1:2000) | Each of the four following standards provide presumption of conformity until 1.10.2011:
  EN 55022:1998
  EN 55022:1998 + A1:2000
  EN 55022:1998 + A2:2003
  EN 55022:1998 + A1:2000 + A2:2003 |
| Amendment A2:2003 to EN 55022:1998
  (CISPR 22:1997/A2:2002) |
| Cenelec | EN 55022:2006 | | | |
| Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement
  (CISPR 22:2005 (modified)) | EN 55022:1998
  and its amendments
  Note 2.1 | 1.10.2009 | Article 3(1)(b) |
| Amendment A1:2007 to EN 55022:2006
  (CISPR 22:2005/A1:2005) | Note 3 | 1.10.2011 | |
| Cenelec | EN 55024:1998 | | | |
| Information technology equipment — Immunity characteristics — Limits and methods of measurement
  (CISPR 24:1997 (modified)) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.7.2001) | Article 3(1)(b) |
| Amendment A1:2001 to EN 55024:1998
  (CISPR 24:1997/A1:2001) | Note 3 | Date expired
  (1.10.2004) | |
| Amendment A2:2003 to EN 55024:1998
  (CISPR 24:1997/A2:2002) | Note 3 | Date expired
  (1.12.2005) | |
| Cenelec | EN 60065:2002 | | | |
| Audio, video and similar electronic apparatus — Safety requirements
  (IEC 60065:2001 (modified)) | EN 60065:1998
  Note 2.1 | Date expired
  (1.3.2007) | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:2006 to EN 60065:2002
  (IEC 60065:2001/A1:2005 (modified)) | Note 3 | Date expired
  (1.12.2008) | |
| Cenelec | EN 60215:1989 | | | |
| Safety requirements for radio transmitting equipment
  (IEC 60215:1987) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:1992 to EN 60215:1989
  (IEC 60215:1987/A1:1990) | Note 3 | Date expired
  (1.6.1993) | |
| Amendment A2:1994 to EN 60215:1989
  (IEC 60215:1987/A2:1993) | Note 3 | Date expired
  (15.7.1995) | |
| Cenelec | EN 60825-1:1994 | | | |
| Safety of laser products — Part 1: Equipment classification, requirements and user’s guide
  (IEC 60825-1:1993) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:2002 to EN 60825-1:1994
  (IEC 60825-1:1993/A1:1997) | EN 60825-1:1994/A11:1996
  Note 3 | Date expired
  (1.1.2004) | |
| Amendment A2:2001 to EN 60825-1:1994
  (IEC 60825-1:1993/A2:2001) | Note 3 | Date expired
  (1.7.2005) | |
| Cenelec | EN 60825-1:2007 | | | |
| Safety of laser products — Part 1: Equipment classification and requirements
  (IEC 60825-1:2007) | EN 60825-1:1994
  and its amendments
  Note 2.1 | 1.9.2010 | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 60825-2:2004 | | | |
| Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS)
  (IEC 60825-2:2004) | EN 60825-2:2000
  Note 2.1 | Date expired
  (1.9.2007) | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:2007 to EN 60825-2:2004
  (IEC 60825-2:2004/A1:2006) | Note 3 | 1.2.2010 | |
| Cenelec | EN 60825-4:1997 | | | |
| Safety of laser products — Part 4: Laser guards
  (IEC 60825-4:1997) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:2002 to EN 60825-4:1997
  (IEC 60825-4:1997/A1:2002) | Note 3 | Date expired
  (1.10.2005) | |
| Amendment A2:2003 to EN 60825-4:1997
  (IEC 60825-4:1997/A2:2003) | Note 3 | Date expired
  (1.10.2006) | |
| Cenelec | EN 60825-4:2006 | | | |
| Safety of laser products — Part 4: Laser guards
  (IEC 60825-4:2006) | EN 60825-4:1997
  and its amendments
  Note 2.1 | Date expired
  (1.10.2009) | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:2008 to EN 60825-4:2006
  (IEC 60825-4:2006/A1:2008) | Note 3 | 1.9.2011 | |
| Cenelec | EN 60825-12:2004 | | | |
| Safety of laser products — Part 12: Safety of free space optical communication systems used for transmission of information
  (IEC 60825-12:2004) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 60950-1:2001 | | | |
| Information technology equipment — Safety — Part 1: General requirements
  (IEC 60950-1:2001 (modified)) | EN 60950:2000
  Note 2.1 | Date expired
  (1.7.2006) | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A11:2004 to EN 60950-1:2001 | Note 3 | — | |
| Cenelec | EN 60950-1:2006 | | | |
| Information technology equipment — Safety — Part 1: General requirements
  (IEC 60950-1:2005 (modified)) | EN 60950-1:2001
  and its amendment
  Note 2.1 | 1.12.2010 | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 60950-22:2006 | | | |
| Information technology equipment — Safety — Part 22: Equipment installed outdoors
  (IEC 60950-22:2005 (modified)) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 60950-23:2006 | | | |
| Information technology equipment — Safety — Part 23: Large data storage equipment
  (IEC 60950-23:2005) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Cenelec | EN 61000-3-2:2006 | | | |
| Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current <= 16 A per phase)
  (IEC 61000-3-2:2005) | EN 61000-3-2:2000
  - A2:2005
  Note 2.1 | Date expired
  (1.2.2009) | Article 3(1)(b) |
| Cenelec | EN 61000-3-3:1995 | | | |
| Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
  (IEC 61000-3-3:1994) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.1.2001) | Article 3(1)(b) |
| Amendment A1:2001 to EN 61000-3-3:1995
  (IEC 61000-3-3:1994/A1:2001) | Note 3 | Date expired
  (1.5.2004) | |
| Cenelec | EN 61000-3-3:2008 | | | |
| Electromagnetic compatibility (EMC) — Part 3-3: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
  (IEC 61000-3-3:2008) | EN 61000-3-3:1995
  and its amendments
  Note 2.1 | 1.9.2011 | Article 3(1)(b) |
| Cenelec | EN 61000-3-11:2000 | | | |
| Electromagnetic compatibility (EMC) — Part 3-11: Limits — Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems — Equipment with rated current <= 75 A and subject to conditional connection
  (IEC 61000-3-11:2000) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.11.2003) | Article 3(1)(b) |
| Cenelec | EN 61000-3-12:2005 | | | |
| Electromagnetic compatibility (EMC) — Part 3-12: Limits — Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and <= 75 A per phase
  (IEC 61000-3-12:2004) | Relevant generic standard(s)
  Note 2.3 | Date expired
  (1.2.2008) | Article 3(1)(b) |
| Cenelec | EN 61000-6-1:2001 | | | |
| Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
  (IEC 61000-6-1:1997 (modified)) | EN 50082-1:1997
  Note 2.1 | Date expired
  (1.7.2004) | Article 3(1)(b) |
| Cenelec | EN 61000-6-1:2007 | | | |
| Electromagnetic compatibility (EMC) — Part 6-1: Generic standards — Immunity for residential, commercial and light-industrial environments
  (IEC 61000-6-1:2005) | EN 61000-6-1:2001
  Note 2.1 | 1.12.2009 | Article 3(1)(b) |
| Cenelec | EN 61000-6-2:2005 | | | |
| Electromagnetic compatibility (EMC) — Part 6-2: Generic standards — Immunity for industrial environments
  (IEC 61000-6-2:2005) | EN 61000-6-2:2001
  Note 2.1 | Date expired
  (1.6.2008) | Article 3(1)(b) |
| Cenelec | EN 61000-6-3:2001 | | | |
| Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments
  (CISPR/IEC 61000-6-3:1996 (modified)) | EN 50081-1:1992
  Note 2.1 | Date expired
  (1.7.2004) | Article 3(1)(b) |
| Amendment A11:2004 to EN 61000-6-3:2001 | Note 3 | Date expired
  (1.7.2007) | |
| Cenelec | EN 61000-6-3:2007 | | | |
| Electromagnetic compatibility (EMC) — Part 6-3: Generic standards — Emission standard for residential, commercial and light-industrial environments
  (IEC 61000-6-3:2006) | EN 61000-6-3:2001
  and its amendment
  Note 2.1 | 1.12.2009 | Article 3(1)(b) |
| Cenelec | EN 61000-6-4:2001 | | | |
| Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments
  (IEC 61000-6-4:1997 (modified)) | EN 50081-2:1993
  Note 2.1 | Date expired
  (1.7.2004) | Article 3(1)(b) |
| Cenelec | EN 61000-6-4:2007 | | | |
| Electromagnetic compatibility (EMC) — Part 6-4: Generic standards — Emission standard for industrial environments
  (IEC 61000-6-4:2006) | EN 61000-6-4:2001
  Note 2.1 | 1.12.2009 | Article 3(1)(b) |
| Cenelec | EN 62311:2008 | | | |
| Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz — 300 GHz)
  (IEC 62311:2007 (modified)) | None | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| ETSI | EN 300 065-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 065-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 300 065-2 V1.1.1 | 28.2.2011 | Article 3(2) |
| ETSI | EN 300 065-3 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 3: Harmonised EN under Article 3(3)(e) of the R & TTE Directive | | | Article 3(3) |
| ETSI | EN 300 065-3 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 3: Harmonised EN covering the essential requirements of Article 3(3)(e) of the R & TTE Directive | EN 300 065-3 V1.1.1 | 28.2.2011 | Article 3(3) |
| ETSI | EN 300 086-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment with an internal or external RF connector intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | ETS 300 086/A2 (02-1997) | Date expired
  (31.8.2002) | Article 3(2) |
| ETSI | EN 300 086-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment with an internal or external RF connector intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | EN 300 086-2 V1.1.1 | 30.6.2010 | Article 3(2) |
| ETSI | EN 300 113-2 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment intended for the transmission of data (and/or speech) using constant or non-constant envelope modulation and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 113-2 V1.3.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 300 135-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Angle-modulated Citizens’ Band radio equipment (CEPT PR 27 radio equipment); Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | ETS 300 135/A1:1997 | Date expired
  (30.4.2001) | Article 3(2) |
| ETSI | EN 300 135-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Citizens’ Band (CB) radio equipment; Angle-modulated Citizens’ Band radio equipment (PR 27 radio equipment); Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 135-2 V1.1.1 | 30.11.2009 | Article 3(2) |
| ETSI | EN 300 162-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radiotelephone transmitters and receivers for the maritime mobile service operating in VHF bands; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 162-2 V1.1.2 | Date expired
  (31.8.2008) | Article 3(2) |
| ETSI | EN 300 162-3 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radiotelephone transmitters and receivers for the maritime mobile service operating in VHF bands; Part 3: Harmonised EN covering essential requirements of Article 3(3)(e) of the R & TTE Directive | EN 300 162-3 V1.1.1 | Date expired
  (31.8.2008) | Article 3(3) |
| ETSI | EN 300 219-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment transmitting signals to initiate a specific response in the receiver; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 220-2 V2.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment to be used in the 25 MHz to 1 000 MHz frequency range with power levels ranging up to 500 mW; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | EN 300 220-2 V2.1.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 300 224-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); On-site paging service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 296-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using integral antennas intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 296-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using integral antennas intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | EN 300 296-2 V1.1.1 | 30.11.2010 | Article 3(2) |
| ETSI | EN 300 328 V1.7.1 (2)

  Electromagnetic compatibility and radio spectrum matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | EN 300 328 V1.6.1 | Date expired
  (30.6.2008) | Article 3(2) |
| ETSI | EN 300 330-2 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 300 330-2 V1.1.1 | Date expired
  (31.12.2007) | Article 3(2) |
| ETSI | EN 300 341-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land Mobile service (RP 02); Radio equipment using an integral antenna transmitting signals to initiate a specific response in the receiver; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 373-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Maritime mobile transmitters and receivers for use in the MF and HF bands Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 373-3 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Maritime mobile transmitters and receivers for use in the MF and HF bands Part 3: Harmonised EN covering essential requirements under Article 3(3)(e) of the R & TTE Directive | | | Article 3(3) |
| ETSI | EN 300 390-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment intended for the transmission of data (and speech) and using an integral antenna; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | ETS 300 390/A1:1997 | Date expired
  (30.4.2001) | Article 3(2) |
| ETSI | EN 300 422-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 422-2 V1.2.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 422-2 V1.1.1 | 31.12.2009 | Article 3(2) |
| ETSI | EN 300 433-2 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Double side band (DSB) and/or single side band (SSB) amplitude modulated Citizens’ Band radio equipment; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | EN 300 433-2 V1.1.1 | Date expired
  (30.9.2002) | Article 3(2) |
| ETSI | EN 300 440-2 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 300 440-2 V1.1.1 | Date expired
  (30.6.2007) | Article 3(2) |
| ETSI | EN 300 440-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 440-2 V1.1.2 | 28.2.2010 | Article 3(2) |
| ETSI | EN 300 440-2 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 300 440-2 V1.2.1 | 31.12.2010 | Article 3(2) |
| ETSI | EN 300 454-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Wide band audio links; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 471-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Rules for access and the sharing of common used channels by equipment complying with EN 300 113; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 674-2-1 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Road transport and traffic telematics (RTTT); Dedicated short-range communication (DSRC) transmission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz industrial, scientific and medical (ISM) band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive; Sub-part 1: Requirements for the roadside units (RSU) | | | Article 3(2) |
| ETSI | EN 300 674-2-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Road transport and traffic telematics (RTTT); Dedicated short-range communication (DSRC) transmission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz industrial, scientific and medical (ISM) band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive; Sub-part 2: Requirements for the on-board units (OBU) | | | Article 3(2) |
| ETSI | EN 300 698-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 698-3 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Part 3: Harmonised EN covering essential requirements of Article 3(3)(e) of the R & TTE Directive | | | Article 3(3) |
| ETSI | EN 300 718-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Avalanche beacons; Transmitter-receiver systems; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 300 718-3 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Avalanche beacons; Transmitter-receiver systems; Part 3: Harmonised EN covering the essential requirements of Article 3(3)(e) of the R & TTE Directive | EN 300 718-3 V1.1.1 | Date expired
  (30.11.2005) | Article 3(3) |
| ETSI | EN 300 720-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Ultra-high frequency (UHF) on-board vessels communications systems and equipment; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 300 720-2 V1.1.1 | Date expired
  (31.7.2009) | Article 3(2) |
| ETSI | EN 300 761-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Automatic vehicle identification (AVI) for railways operating in the 2,45 GHz frequency range; Part 2: Harmonised standard covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 025-2 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); VHF radiotelephone equipment for general communications and associated equipment for class ‘D’ digital selective calling (DSC); Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 301 025-2 V1.2.1 | Date expired
  (31.10.2008) | Article 3(2) |
| ETSI | EN 301 025-3 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); VHF radiotelephone equipment for general communications and associated equipment for Class ‘D’ digital selective calling (DSC); Part 3: Harmonised EN under Article 3(3)(e) of the R & TTE Directive | EN 301 025-3 V1.2.1 | Date expired
  (31.10.2008) | Article 3(3) |
| ETSI | EN 301 091-2 V1.3.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Radar equipment operating in the 76 GHz to 77 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 091-2 V1.2.1 | Date expired
  (30.6.2008) | Article 3(2) |
| ETSI | EN 301 166-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment for analogue and/or digital communication (speech and/or data) and operating on narrow band channels and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 166-2 V1.1.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 301 166-2 V1.2.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment for analogue and/or digital communication (speech and/or data) and operating on narrow band channels and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 166-2 V1.2.1 | 31.5.2010 | Article 3(2) |
| ETSI | EN 301 178-2 V1.2.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Portable very high frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands (for non-GMDSS applications only); Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 178-2 V1.1.1 | Date expired
  (31.10.2008) | Article 3(2) |
| ETSI | EN 301 357-2 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Cordless audio devices in the range 25 MHz to 2 000 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 357-2 V1.2.1 | Date expired
  (30.4.2008) | Article 3(2) |
| ETSI | EN 301 357-2 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM);Cordless audio devices in the range 25 MHz to 2 000 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 357-2 V1.3.1 | 31.8.2010 | Article 3(2) |
| ETSI | EN 301 360 V1.2.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite interactive terminals (SIT) and satellite user terminals (SUT) transmitting towards geostationary satellites in the 27,5 GHz to 29,5 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 360 V1.1.3 | Date expired
  (30.11.2007) | Article 3(2) |
| ETSI | EN 301 406 V1.5.1
  Digital enhanced cordless telecommunications (DECT); Harmonised EN for digital enhanced cordless telecommunications (DECT) covering essential requirements under Article 3(2) of the R & TTE Directive; Generic radio | EN 301 406 V1.4.1 | Date expired
  (31.3.2005) | Article 3(2) |
| ETSI | EN 301 406 V2.1.1
  Digital enhanced cordless telecommunications (DECT); Harmonised EN for digital enhanced cordless telecommunications (DECT) covering the essential requirements under Article 3(2) of the R & TTE Directive; Generic radio | EN 301 406 V1.5.1 | 30.4.2011 | Article 3(2) |
| ETSI | EN 301 419-1 V4.0.1
  Digital cellular telecommunications system (Phase 2); Attachment requirements for global system for mobile communications (GSM); Part 1: Mobile stations in the GSM 900 and DCS 1 800 bands; Access (GSM 13.01 version 4.0.1) | | | Article 3(2) |
| ETSI | EN 301 419-2 V5.1.1
  Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); High-speed circuit-switched data (HSCSD) multislot mobile stations; Access (GSM 13.34 version 5.1.1 Release 1996) | | | Article 3(2) |
| ETSI | EN 301 419-3 V5.0.2
  Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); Advanced speech call items (ASCI); Mobile stations; Access (GSM 13.68 version 5.0.2 Release 1996) | | | Article 3(2) |
| ETSI | EN 301 419-7 V5.0.2
  Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); Railways Band (R-GSM); Mobile stations; Access (GSM 13.67 version 5.0.2 Release 1996) | | | Article 3(2) |
| ETSI | EN 301 423 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised standard for the terrestrial flight telecommunications system under Article 3(2) of the R & TTE Directive | TBR 23: 1998 | Date expired
  (30.9.2002) | Article 3(2) |
| ETSI | EN 301 426 V1.2.1
  Satellite earth stations and systems (SES); Harmonised EN for low data rate land mobile satellite earth stations (LMES) and maritime mobile satellite earth stations (MMES) not intended for distress and safety communications operating in the 1,5/1,6 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 426 V1.1.1 | Date expired
  (30.6.2002) | Article 3(2) |
| ETSI | EN 301 427 V1.2.1
  Satellite earth stations and systems (SES); Harmonised EN for low data rate mobile satellite earth stations (MESs) except aeronautical mobile satellite earth stations, operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 427 V1.1.1 | Date expired
  (31.8.2003) | Article 3(2) |
| ETSI | EN 301 428 V1.3.1
  Satellite earth stations and systems (SES); Harmonised EN for very small aperture terminal (VSAT); Transmit-only, transmit/receive or receive-only satellite earth stations operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 428 V1.2.1 | Date expired
  (30.6.2007) | Article 3(2) |
| ETSI | EN 301 430 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite news gathering transportable earth stations (SNG TES) operating in the 11-12/13-14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | TBR 30: 1998 | Date expired
  (31.1.2001) | Article 3(2) |
| ETSI | EN 301 441 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs), including handheld earth stations, for satellite personal communications networks (S-PCN) in the 1,6/2,4 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive | TBR 41: 1998 | Date expired
  (31.1.2001) | Article 3(2) |
| ETSI | EN 301 442 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs), including handheld earth stations, for satellite personal communications networks (S-PCN) in the 2,0 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive | TBR 42: 1998 | Date expired
  (31.1.2001) | Article 3(2) |
| ETSI | EN 301 443 V1.3.1
  Satellite earth stations and systems (SES); Harmonised EN for very small aperture terminal (VSAT); Transmit-only, transmit-and-receive, receive-only satellite earth stations operating in the 4 GHz and 6 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 443 V1.2.1 | Date expired
  (30.11.2007) | Article 3(2) |
| ETSI | EN 301 444 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for land mobile earth stations (LMES) operating in the 1,5 GHz and 1,6 GHz bands providing voice and/or data communications covering essential requirements under Article 3(2) of the R & TTE Directive | TBR 44: 1998 | Date expired
  (31.1.2001) | Article 3(2) |
| ETSI | EN 301 447 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite earth stations on board vessels (ESVs) operating in the 4/6 GHz frequency bands allocated to the fixed satellite service (FSS) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 449 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum base stations operating in the 450 MHz cellular band (CDMA 450) and 410, 450 and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 459 V1.4.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite interactive terminals (SIT) and satellite user terminals (SUT) transmitting towards satellites in geostationary orbit in the 29,5 GHz to 30,0 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 459 V1.3.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 301 489-1 V1.6.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements | EN 301 489-1 V1.5.1 | Date expired
  (30.11.2008) | Article 3(1)(b) |
| ETSI | EN 301 489-1 V1.8.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements | EN 301 489-1 V1.6.1 | 31.1.2011 | Article 3(1)(b) |
| ETSI | EN 301 489-10 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 10: Specific conditions for First (CT1 and CT1+) and second generation cordless telephone (CT2) equipment | EN 301 489-10 V1.2.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-11 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 11: Specific conditions for terrestrial sound broadcasting service transmitters | EN 301 489-11 V1.2.1 | Date expired
  (30.11.2007) | Article 3(1)(b) |
| ETSI | EN 301 489-12 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 12: Specific conditions for very small aperture terminal, satellite interactive earth stations operated in the frequency ranges between 4 GHz and 30 GHz in the fixed satellite service (FSS) | EN 301 489-12 V1.1.1 | Date expired
  (31.7.2006) | Article 3(1)(b) |
| ETSI | EN 301 489-12 V2.2.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 12: Specific conditions for very small aperture terminal, satellite interactive earth stations operated in the frequency ranges between 4 GHz and 30 GHz in the fixed satellite service (FSS) | EN 301 489-12 V1.2.1 | 30.6.2010 | Article 3(1)(b) |
| ETSI | EN 301 489-13 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 13: Specific conditions for Citizens’ Band (CB) radio and ancillary equipment (speech and non-speech) | EN 301 489-13 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-14 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 14: Specific conditions for analogue and digital terrestrial TV broadcasting service transmitters | EN 301 489-14 V1.1.1 | Date expired
  (31.7.2006) | Article 3(1)(b) |
| ETSI | EN 301 489-15 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 15: Specific conditions for commercially available amateur radio equipment | EN 301 489-15 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-16 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 16: Specific conditions for analogue cellular radio communications equipment, mobile and portable | EN 301 489-16 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-17 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for 2,4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment | EN 301 489-17 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-17 V1.3.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for 2,4 GHz wideband transmission systems, 5 GHz high performance RLAN equipment and 5,8 GHz broadband data transmitting systems | EN 301 489-17 V1.2.1 | 31.7.2010 | Article 3(1)(b) |
| ETSI | EN 301 489-17 V2.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for broadband data transmission systems | EN 301 489-17 V1.3.2 | 31.1.2011 | Article 3(1)(b) |
| ETSI | EN 301 489-18 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 18: Specific conditions for terrestrial trunked radio (TETRA) equipment | EN 301 489-18 V1.2.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-19 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 19: Specific conditions for receive only mobile earth stations (ROMES) operating in the 1,5 GHz band providing data communication | EN 301 489-19 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-2 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 2: Specific conditions for radio paging equipment | EN 301 489-02 V1.2.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-20 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 20: Specific conditions for mobile earth stations (MES) used in the mobile satellite services (MSS) | EN 301 489-20 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-22 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 22: Specific requirements for ground-based VHF aeronautical mobile and fixed radio equipment | EN 301 489-22 V1.2.1 | Date expired
  (28.2.2007) | Article 3(1)(b) |
| ETSI | EN 301 489-23 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 23: Specific conditions for IMT-2000 CDMA direct spread (UTRA) base station (BS) radio, repeater and ancillary equipment | EN 301 489-23 V1.2.1 | Date expired
  (31.5.2009) | Article 3(1)(b) |
| ETSI | EN 301 489-24 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 24: Specific conditions for IMT-2000 CDMA direct spread (UTRA) for mobile and portable (UE) radio and ancillary equipment | EN 301 489-24 V1.3.1
  EN 301 489-24 V1.3.1 | Date expired
  (31.5.2009) | Article 3(1)(b) |
| ETSI | EN 301 489-25 V2.3.2 (7-2005)
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 25: Specific conditions for CDMA 1x spread spectrum mobile stations and ancillary equipment | EN 301 489-25 V2.2.1 | Date expired
  (30.4.2007) | Article 3(1)(b) |
| ETSI | EN 301 489-26 V2.3.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 26: Specific conditions for CDMA 1x spread spectrum base stations, repeaters and ancillary equipment | EN 301 489-26 V2.2.1 | Date expired
  (30.4.2007) | Article 3(1)(b) |
| ETSI | EN 301 489-27 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for ultra low power active medical implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) | | | Article 3(1)(b) |
| ETSI | EN 301 489-28 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 28: Specific conditions for wireless digital video links | | | Article 3(1)(b) |
| ETSI | EN 301 489-29 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM);Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for medical data service devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands | | | Article 3(1)(b) |
| ETSI | EN 301 489-3 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for short-range devices (SRD) operating on frequencies between 9 kHz and 40 GHz | EN 301 489-03 V1.3.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-31 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for ultra low power active medical implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)) | | | Article 3(1)(b) |
| ETSI | EN 301 489-32 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 32: Specific conditions for ground and wall probing radar applications | | | Article 3(1)(b) |
| ETSI | EN 301 489-33 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM);Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 33: Specific conditions for ultra wide band (UWB) communications devices | | | Article 3(1)(b) |
| ETSI | EN 301 489-4 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 4: Specific conditions for fixed radio links and ancillary equipment and services | EN 301 489-04 V1.2.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-4 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 4: Specific conditions for fixed radio links, broadband data transmission system base stations, ancillary equipment and services | EN 301 489-4 V1.3.1 | 31.1.2011 | Article 3(1)(b) |
| ETSI | EN 301 489-5 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 5: Specific conditions for private land mobile radio (PMR) and ancillary equipment (speech and non-speech) | EN 301 489-05 V1.2.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-6 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 6: Specific conditions for digital enhanced cordless telecommunications (DECT) equipment | EN 301 489-6 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-6 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 6: Specific conditions for digital enhanced cordless telecommunications (DECT) equipment | EN 301 489-6 V1.2.1 | 31.5.2010 | Article 3(1)(b) |
| ETSI | EN 301 489-7 V1.3.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 7: Specific conditions for mobile and portable radio and ancillary equipment of digital cellular radio telecommunications systems (GSM and DCS) | EN 301 489-07 V1.2.1 | Date expired
  (31.1.2009) | Article 3(1)(b) |
| ETSI | EN 301 489-8 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 8: Specific conditions for GSM base stations | EN 301 489-08 V1.1.1 | Date expired
  (30.11.2005) | Article 3(1)(b) |
| ETSI | EN 301 489-9 V1.4.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 9: Specific conditions for wireless microphones, similar Radio Frequency (RF) audio link equipment, cordless audio and in-ear monitoring devices | EN 301 489-9 V1.3.1 | Date expired
  (31.8.2009) | Article 3(1)(b) |
| ETSI | EN 301 502 V8.1.2
  Harmonised EN for global system for mobile communications (GSM); Base Station and Repeater equipment covering essential requirements under Article 3(2) of the R & TTE Directive (GSM 13.21 version 8.0.1 Release 1999) | EN 301 502 V7.0.1 | Date expired
  (30.4.2002) | Article 3(2) |
| ETSI | EN 301 511 V9.0.2
  Global system for mobile communications (GSM); Harmonised EN for mobile stations in the GSM 900 and GSM 1 800 bands covering essential requirements under Article 3(2) of the R & TTE Directive (1999/5/EC) | EN 301 511 V7.0.1 | Date expired
  (30.6.2004) | Article 3(2) |
| ETSI | EN 301 526 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum mobile stations operating in the 450 MHz cellular band (CDMA 450) and 410, 450 and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 681 V1.3.2
  Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs) of geostationary mobile satellite systems, including handheld earth stations, for satellite personal communications networks (S-PCN) in the 1,5/1,6 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 681 V1.2.1 | Date expired
  (31.3.2006) | Article 3(2) |
| ETSI | EN 301 721 V1.2.1
  Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MES) providing low bit rate data communications (LBRDC) using low earth orbiting (LEO) satellites operating below 1 GHz covering essential requirements under Article 3(2) of the R & TTE Directive | EN 301 721 V1.1.1 | Date expired
  (31.3.2002) | Article 3(2) |
| ETSI | EN 301 783-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Commercially available amateur radio equipment; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 796 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CT1 and CT1+ cordless telephone equipment covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 797 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CT2 cordless telephone equipment covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 839-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ultra low power active medical implants (ULP-AMI) and peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 839-2 V1.1.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 301 840-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Digital radio microphones operating in the CEPT harmonised band 1 785 MHz to 1 800 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 843-1 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 1: Common technical requirements | EN 301 843-1 V1.1.1 | Date expired
  (31.3.2006) | Article 3(1)(b) |
| ETSI | EN 301 843-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 2: Specific conditions for VHF radiotelephone transmitters and receivers | EN 301 843-2 V1.1.1 | Date expired
  (31.3.2006) | Article 3(1)(b) |
| ETSI | EN 301 843-4 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 4: Specific conditions for narrow-band direct-printing (NBDP) Navtex receivers | EN 301 843-4 V1.1.1 | Date expired
  (31.3.2006) | Article 3(1)(b) |
| ETSI | EN 301 843-5 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 5: Specific conditions for MF/HF radiotelephone transmitters and receivers | | | Article 3(1)(b) |
| ETSI | EN 301 843-6 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 6: Specific conditions for earth stations on board vessels operating in frequency bands above 3 GHz | | | Article 3(1)(b) |
| ETSI | EN 301 893 V1.4.1 (3)

  Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 893 V1.3.1 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 301 893 V1.5.1
  Broadband radio access networks (BRAN);5 GHz high performance RLAN; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 301 893 V1.4.1 | 30.6.2010 | Article 3(2) |
| ETSI | EN 301 908-1 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 1: Harmonised EN for IMT-2000, introduction and common requirements, covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-01 V2.2.1 | Date expired
  (31.1.2009) | Article 3(2) |
| ETSI | EN 301 908-10 V2.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 10: Harmonised EN for IMT-2000, FDMA/TDMA (DECT) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-10 V1.1.1 | Date expired
  (30.9.2005) | Article 3(2) |
| ETSI | EN 301 908-10 V4.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), Repeaters and user equipment (UE) for IMT-2000 third-generation cellular networks; Part 10: Harmonised EN for IMT-2000, FDMA/TDMA (DECT) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-10 V2.1.1 | 30.4.2011 | Article 3(2) |
| ETSI | EN 301 908-11 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 11: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (repeaters) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-11 V2.3.1 | Date expired
  (31.1.2009) | Article 3(2) |
| ETSI | EN 301 908-12 V3.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 12: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (repeaters) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 908-2 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 2: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-02 V2.2.1 | Date expired
  (31.1.2009) | Article 3(2) |
| ETSI | EN 301 908-3 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 3: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-03 V2.2.1 | Date expired
  (31.1.2009) | Article 3(2) |
| ETSI | EN 301 908-4 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 4: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-04 V2.2.1 | Date expired
  (31.5.2009) | Article 3(2) |
| ETSI | EN 301 908-5 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 5: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-05 V2.2.1 | Date expired
  (31.5.2009) | Article 3(2) |
| ETSI | EN 301 908-6 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 6: Harmonised EN for IMT-2000, CDMA TDD (UTRA TDD) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-06 V2.2.1 | Date expired
  (31.5.2009) | Article 3(2) |
| ETSI | EN 301 908-7 V3.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 7: Harmonised EN for IMT-2000, CDMA TDD (UTRA TDD) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive | EN 301 908-07 V2.2.2 and EN 301 908-07 V2.2.1 | Date expired
  (31.1.2009) | Article 3(2) |
| ETSI | EN 301 908-8 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS) and user equipment (UE) for IMT-2000 third generation cellular networks; Part 8: Harmonised EN for IMT-2000, TDMA single-carrier (UWC 136) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 908-9 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS) and user equipment (UE) for IMT-2000 third generation cellular networks; Part 9: Harmonised EN for IMT-2000, TDMA single-carrier (UWC 136) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 301 929-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); VHF transmitters and receivers as coast stations for GMDSS and other applications in the maritime mobile services; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 301 929-2 V1.1.1 | Date expired
  (30.11.2008) | Article 3(2) |
| ETSI | EN 301 997-2 V1.1.1
  Transmission and Multiplexing (TM); Multipoint equipment; Radio equipment for use in multimedia wireless systems (MWS) in the frequency band 40,5 GHz to 43,5 GHz; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 017-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the amplitude modulated (AM) sound broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 018-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the frequency modulated (FM) sound broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | EN 302 018-2 V1.1.1 | Date expired
  (30.11.2007) | Article 3(2) |
| ETSI | EN 302 054-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Meteorological aids (Met Aids); Radiosondes to be used in the 400,15 MHz to 406 MHz frequency range with power levels ranging up to 200 mW; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 064-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Wireless video links (WVL) operating in the 1,3 GHz to 50 GHz frequency band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 065 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Ultra wide band (UWB) technologies for communication purposes; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 066-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ground- and wall- probing radar applications; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 066-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Ground- and wall- probing radar applications (GPR/WPR) imaging systems; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 302 066-2 V1.1.1 | 30.11.2009 | Article 3(2) |
| ETSI | EN 302 077-2 V.1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the terrestrial-digital audio broadcasting (T-DAB) service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 186 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite mobile aircraft earth stations (AESs)operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 194-2 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Navigation radar used on inland waterways; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 195-2 V1.1.1 (3-2004)
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for ultra low power active medical implants (ULP-AMI) and accessories; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 208-2 V.1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio frequency identification equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 208-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio frequency identification equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 302 208-2 V1.1.1 | 31.12.2009 | Article 3(2) |
| ETSI | EN 302 217-2-2 V1.2.3
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2-2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for digital systems operating in frequency bands where frequency coordination is applied | EN 302 217-2-2 V1.1.3 | Date expired
  (31.5.2009) | Article 3(2) |
| ETSI | EN 302 217-2-2 V1.3.1
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2-2: Digital systems operating in frequency bands where frequency coordination is applied; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 302 217-2-2 V1.2.3 | 31.1.2011 | Article 3(2) |
| ETSI | EN 302 217-3 V1.1.3
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 3: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for equipment operating in frequency bands where no frequency coordination is applied | EN 301 751 V1.2.1 | Date expired
  (31.5.2007) | Article 3(2) |
| ETSI | EN 302 217-3 V1.2.1
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 3: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for equipment operating in frequency bands where simplified or no frequency coordination procedures are applied | EN 302 217-3 V1.1.3 | 30.11.2009 | Article 3(2) |
| ETSI | EN 302 217-4-2 V1.3.1
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for antennas | EN 302 217-4-2 V1.2.1 | Date expired
  (31.7.2009) | Article 3(2) |
| ETSI | EN 302 217-4-2 V1.4.1
  Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Antennas; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 302 217-4-2 V1.3.1 | 31.12.2010 | Article 3(2) |
| ETSI | EN 302 245-2 V.1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the digital radio mondiale (DRM) broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 248 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Navigation radar for use on non-SOLAS vessels; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 264-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 77 GHz to 81 GHz band; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 288-2 V1.2.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 24 GHz range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 302 288-2 V1.2.1 | Date expired
  (31.5.2009) | Article 3(2) |
| ETSI | EN 302 288-2 V1.3.2
  Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 24 GHz range; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 302 208 V1.2.2 | 31.10.2010 | Article 3(2) |
| ETSI | EN 302 291-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Close range inductive data communication equipment operating at 13,56 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 296 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the digital television broadcast service, Terrestrial (DVB-T); Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 297 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the analogue television broadcasting service; Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 326-2 V1.2.2
  Fixed radio systems; Multipoint equipment and antennas; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for digital multipoint radio equipment | EN 302 326-2 V1.1.2 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 302 326-3 V1.2.2
  Fixed radio systems; Multipoint equipment and antennas; Part 3: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for multipoint radio antennas | EN 302 326-3 V1.1.2 | Date expired
  (31.3.2009) | Article 3(2) |
| ETSI | EN 302 326-3 V1.3.1
  Fixed radio systems; Multipoint equipment and antennas; Part 3: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for multipoint radio antennas | EN 302 326-3 V1.2.2 | Date expired
  (31.10.2009) | Article 3(2) |
| ETSI | EN 302 340 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for satellite earth stations on board vessels (ESVs) operating in the 11/12/14 GHz frequency bands allocated to the Fixed Satellite Service (FSS) covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 372-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Equipment for detection and movement; Tanks level probing radar (TLPR) operating in the frequency bands 5,8 GHz, 10 GHz, 25 GHz, 61 GHz and 77 GHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 426 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum repeaters operating in the 450 MHz cellular band (CDMA450) and the 410 MHz, 450 MHz and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 435-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Technical characteristics for SRD equipment using ultra wide band technology (UWB); Building material analysis and classification equipment applications operating in the frequency band from 2,2 GHz to 8 GHz; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 448 V1.1.1
  Satellite earth stations and systems (SES); Harmonised EN for tracking earth stations on trains (ESTs) operating in the 14/12 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 454-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Meteorological aids (Met Aids); Radiosondes to be used in the 1 668,4 MHz to 1 690 MHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 480 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for the GSM onboard aircraft system covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 500-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD) using ultra wide band (UWB) technology; Location tracking equipment operating in the frequency range from 6 GHz to 8,5 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 500-2 V1.2.1
  Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices (SRD) using ultra wide band (UWB) technology; Location tracking equipment operating in the frequency range from 6 GHz to 8,5 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | EN 302 500-2 V1.1.1 | 31.3.2010 | Article 3(2) |
| ETSI | EN 302 502 V1.1.1
  Broadband radio access networks (BRAN); 5,8 GHz fixed broadband data transmitting systems; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 502 V1.2.1
  Broadband radio access networks (BRAN); 5,8 GHz fixed broadband data transmitting systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | EN 302 502 V1.1.1 | 31.3.2010 | Article 3(2) |
| ETSI | EN 302 510-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for ultra low power active medical membrane implants and accessories; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 536-2 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 537-2 V1.1.2
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ultra low power medical data service systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 544-1 V1.1.1
  Broadband data transmission systems operating in the 2 500 MHz to 2 690 MHz frequency band; Part 1: TDD base stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 544-2 V1.1.1
  Broadband data transmission systems operating in the 2 500 MHz to 2 690 MHz frequency band; Part 2: TDD user equipment stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 561 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using constant or non-constant envelope modulation operating in a channel bandwidth of 25 kHz, 50 kHz, 100 kHz or 150 kHz; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 567 V1.1.1
  Broadband radio access networks (BRAN); 60 GHz multiple-gigabit WAS/RLAN systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 571 V1.1.1
  Intelligent transport systems (ITS); Radiocommunications equipment operating in the 5 855 MHz to 5 925 MHz frequency band; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 608 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment for Eurobalise railway systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 609 V1.1.1
  Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices (SRD); Radio equipment for Euroloop railway systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 302 623 V1.1.1
  Broadband wireless access systems (BWA) in the 3 400 MHz to 3 800 MHz frequency band; Mobile terminal stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive | | | Article 3(2) |
| ETSI | EN 303 035-1 V1.2.1
  Terrestrial trunked radio (TETRA); Harmonised EN for TETRA equipment covering essential requirements under Article 3(2) of the R & TTE Directive; Part 1: Voice plus Data (V+D) | EN 303 035-1 V1.1.1 | Date expired
  (30.9.2003) | Article 3(2) |
| ETSI | EN 303 035-2 V1.2.2
  Terrestrial trunked radio (TETRA); Harmonised EN for TETRA equipment covering essential requirements under Article 3(2) of the R & TTE Directive; Part 2: Direct mode operation (DMO) | EN 303 035-2 V1.2.1 | Date expired
  (31.10.2004) | Article 3(2) |
| ETSI | ETS 300 487/A1:1997
  Satellite earth stations and systems (SES); Receive-only mobile earth stations (ROMES) operating in the 1,5 GHz band providing data communications; Radio frequency (RF) specifications | | | Article 3(2) |

European Standards Organisation (1)

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

Note 1

Article 1999/5/EC

Cenelec

EN 41003:1998

Particular safety requirements for equipment to be connected to telecommunication networks

EN 41003:1996

Note 2.1

Date expired

(1.1.2002)

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 50360:2001

Product standard to demonstrate the compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields (300 MHz — 3 GHz)

None

—

Article 3(1)(a)

Cenelec

EN 50364:2001

Limitation of human exposure to electromagnetic fields from devices operating in the frequency range 0 Hz to 10 GHz, used in electronic article surveillance (EAS), radio frequency identification (RFID) and similar applications

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 50371:2002

Generic standard to demonstrate the compliance of low power electronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields (10 MHz — 300 GHz) — General public

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 50385:2002

Product standard to demonstrate the compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions or the reference levels related to human exposure to radio frequency electromagnetic fields (110 MHz — 40 GHz) — General public

None

—

Article 3(1)(a)

Cenelec

EN 50401:2006

Product standard to demonstrate the compliance of fixed equipment for radio transmission (110 MHz — 40 GHz) intended for use in wireless telecommunication networks with the basic restrictions or the reference levels related to general public exposure to radio frequency electromagnetic fields, when put into service

None

—

Article 3(1)(a)

Cenelec

EN 55022:1998

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

(CISPR 22:1997 (modified))

EN 55022:1994

- A1:1995

- A2:1997

Note 2.1

Date expired

(1.8.2007)

Article 3(1)(b)

Amendment A1:2000 to EN 55022:1998

(CISPR 22:1997/A1:2000)

Each of the four following standards provide presumption of conformity until 1.10.2011:

EN 55022:1998

EN 55022:1998 + A1:2000

EN 55022:1998 + A2:2003

EN 55022:1998 + A1:2000 + A2:2003

Amendment A2:2003 to EN 55022:1998

(CISPR 22:1997/A2:2002)

Cenelec

EN 55022:2006

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

(CISPR 22:2005 (modified))

EN 55022:1998

and its amendments

Note 2.1

1.10.2009

Article 3(1)(b)

Amendment A1:2007 to EN 55022:2006

(CISPR 22:2005/A1:2005)

Note 3

1.10.2011

Cenelec

EN 55024:1998

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

(CISPR 24:1997 (modified))

Relevant generic standard(s)

Note 2.3

Date expired

(1.7.2001)

Article 3(1)(b)

Amendment A1:2001 to EN 55024:1998

(CISPR 24:1997/A1:2001)

Note 3

Date expired

(1.10.2004)

Amendment A2:2003 to EN 55024:1998

(CISPR 24:1997/A2:2002)

Note 3

Date expired

(1.12.2005)

Cenelec

EN 60065:2002

Audio, video and similar electronic apparatus — Safety requirements

(IEC 60065:2001 (modified))

EN 60065:1998

Note 2.1

Date expired

(1.3.2007)

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:2006 to EN 60065:2002

(IEC 60065:2001/A1:2005 (modified))

Note 3

Date expired

(1.12.2008)

Cenelec

EN 60215:1989

Safety requirements for radio transmitting equipment

(IEC 60215:1987)

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:1992 to EN 60215:1989

(IEC 60215:1987/A1:1990)

Note 3

Date expired

(1.6.1993)

Amendment A2:1994 to EN 60215:1989

(IEC 60215:1987/A2:1993)

Note 3

Date expired

(15.7.1995)

Cenelec

EN 60825-1:1994

Safety of laser products — Part 1: Equipment classification, requirements and user’s guide

(IEC 60825-1:1993)

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:2002 to EN 60825-1:1994

(IEC 60825-1:1993/A1:1997)

EN 60825-1:1994/A11:1996

Note 3

Date expired

(1.1.2004)

Amendment A2:2001 to EN 60825-1:1994

(IEC 60825-1:1993/A2:2001)

Note 3

Date expired

(1.7.2005)

Cenelec

EN 60825-1:2007

Safety of laser products — Part 1: Equipment classification and requirements

(IEC 60825-1:2007)

EN 60825-1:1994

and its amendments

Note 2.1

1.9.2010

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 60825-2:2004

Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS)

(IEC 60825-2:2004)

EN 60825-2:2000

Note 2.1

Date expired

(1.9.2007)

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:2007 to EN 60825-2:2004

(IEC 60825-2:2004/A1:2006)

Note 3

1.2.2010

Cenelec

EN 60825-4:1997

Safety of laser products — Part 4: Laser guards

(IEC 60825-4:1997)

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:2002 to EN 60825-4:1997

(IEC 60825-4:1997/A1:2002)

Note 3

Date expired

(1.10.2005)

Amendment A2:2003 to EN 60825-4:1997

(IEC 60825-4:1997/A2:2003)

Note 3

Date expired

(1.10.2006)

Cenelec

EN 60825-4:2006

Safety of laser products — Part 4: Laser guards

(IEC 60825-4:2006)

EN 60825-4:1997

and its amendments

Note 2.1

Date expired

(1.10.2009)

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:2008 to EN 60825-4:2006

(IEC 60825-4:2006/A1:2008)

Note 3

1.9.2011

Cenelec

EN 60825-12:2004

Safety of laser products — Part 12: Safety of free space optical communication systems used for transmission of information

(IEC 60825-12:2004)

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 60950-1:2001

Information technology equipment — Safety — Part 1: General requirements

(IEC 60950-1:2001 (modified))

EN 60950:2000

Note 2.1

Date expired

(1.7.2006)

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A11:2004 to EN 60950-1:2001

Note 3

—

Cenelec

EN 60950-1:2006

Information technology equipment — Safety — Part 1: General requirements

(IEC 60950-1:2005 (modified))

EN 60950-1:2001

and its amendment

Note 2.1

1.12.2010

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 60950-22:2006

Information technology equipment — Safety — Part 22: Equipment installed outdoors

(IEC 60950-22:2005 (modified))

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 60950-23:2006

Information technology equipment — Safety — Part 23: Large data storage equipment

(IEC 60950-23:2005)

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Cenelec

EN 61000-3-2:2006

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

(IEC 61000-3-2:2005)

EN 61000-3-2:2000

- A2:2005

Note 2.1

Date expired

(1.2.2009)

Article 3(1)(b)

Cenelec

EN 61000-3-3:1995

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

(IEC 61000-3-3:1994)

Relevant generic standard(s)

Note 2.3

Date expired

(1.1.2001)

Article 3(1)(b)

Amendment A1:2001 to EN 61000-3-3:1995

(IEC 61000-3-3:1994/A1:2001)

Note 3

Date expired

(1.5.2004)

Cenelec

EN 61000-3-3:2008

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

(IEC 61000-3-3:2008)

EN 61000-3-3:1995

and its amendments

Note 2.1

1.9.2011

Article 3(1)(b)

Cenelec

EN 61000-3-11:2000

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

(IEC 61000-3-11:2000)

Relevant generic standard(s)

Note 2.3

Date expired

(1.11.2003)

Article 3(1)(b)

Cenelec

EN 61000-3-12:2005

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

(IEC 61000-3-12:2004)

Relevant generic standard(s)

Note 2.3

Date expired

(1.2.2008)

Article 3(1)(b)

Cenelec

EN 61000-6-1:2001

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

(IEC 61000-6-1:1997 (modified))

EN 50082-1:1997

Note 2.1

Date expired

(1.7.2004)

Article 3(1)(b)

Cenelec

EN 61000-6-1:2007

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

(IEC 61000-6-1:2005)

EN 61000-6-1:2001

Note 2.1

1.12.2009

Article 3(1)(b)

Cenelec

EN 61000-6-2:2005

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

(IEC 61000-6-2:2005)

EN 61000-6-2:2001

Note 2.1

Date expired

(1.6.2008)

Article 3(1)(b)

Cenelec

EN 61000-6-3:2001

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

(CISPR/IEC 61000-6-3:1996 (modified))

EN 50081-1:1992

Note 2.1

Date expired

(1.7.2004)

Article 3(1)(b)

Amendment A11:2004 to EN 61000-6-3:2001

Note 3

Date expired

(1.7.2007)

Cenelec

EN 61000-6-3:2007

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

(IEC 61000-6-3:2006)

EN 61000-6-3:2001

and its amendment

Note 2.1

1.12.2009

Article 3(1)(b)

Cenelec

EN 61000-6-4:2001

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

(IEC 61000-6-4:1997 (modified))

EN 50081-2:1993

Note 2.1

Date expired

(1.7.2004)

Article 3(1)(b)

Cenelec

EN 61000-6-4:2007

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

(IEC 61000-6-4:2006)

EN 61000-6-4:2001

Note 2.1

1.12.2009

Article 3(1)(b)

Cenelec

EN 62311:2008

Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz — 300 GHz)

(IEC 62311:2007 (modified))

None

—

Article 3(1)(a) (and Article 2 2006/95/EC)

ETSI

EN 300 065-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 065-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 300 065-2 V1.1.1

28.2.2011

Article 3(2)

ETSI

EN 300 065-3 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 3: Harmonised EN under Article 3(3)(e) of the R & TTE Directive

Article 3(3)

ETSI

EN 300 065-3 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Narrow-band direct-printing telegraph equipment for receiving meteorological or navigational information (Navtex); Part 3: Harmonised EN covering the essential requirements of Article 3(3)(e) of the R & TTE Directive

EN 300 065-3 V1.1.1

28.2.2011

Article 3(3)

ETSI

EN 300 086-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment with an internal or external RF connector intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

ETS 300 086/A2 (02-1997)

Date expired

(31.8.2002)

Article 3(2)

ETSI

EN 300 086-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment with an internal or external RF connector intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

EN 300 086-2 V1.1.1

30.6.2010

Article 3(2)

ETSI

EN 300 113-2 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment intended for the transmission of data (and/or speech) using constant or non-constant envelope modulation and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 113-2 V1.3.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 300 135-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Angle-modulated Citizens’ Band radio equipment (CEPT PR 27 radio equipment); Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

ETS 300 135/A1:1997

Date expired

(30.4.2001)

Article 3(2)

ETSI

EN 300 135-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Citizens’ Band (CB) radio equipment; Angle-modulated Citizens’ Band radio equipment (PR 27 radio equipment); Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 135-2 V1.1.1

30.11.2009

Article 3(2)

ETSI

EN 300 162-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radiotelephone transmitters and receivers for the maritime mobile service operating in VHF bands; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 162-2 V1.1.2

Date expired

(31.8.2008)

Article 3(2)

ETSI

EN 300 162-3 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radiotelephone transmitters and receivers for the maritime mobile service operating in VHF bands; Part 3: Harmonised EN covering essential requirements of Article 3(3)(e) of the R & TTE Directive

EN 300 162-3 V1.1.1

Date expired

(31.8.2008)

Article 3(3)

ETSI

EN 300 219-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment transmitting signals to initiate a specific response in the receiver; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 220-2 V2.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment to be used in the 25 MHz to 1 000 MHz frequency range with power levels ranging up to 500 mW; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

EN 300 220-2 V2.1.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 300 224-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); On-site paging service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 296-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using integral antennas intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 296-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using integral antennas intended primarily for analogue speech; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

EN 300 296-2 V1.1.1

30.11.2010

Article 3(2)

ETSI

EN 300 328 V1.7.1 (2)

Electromagnetic compatibility and radio spectrum matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

EN 300 328 V1.6.1

Date expired

(30.6.2008)

Article 3(2)

ETSI

EN 300 330-2 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 300 330-2 V1.1.1

Date expired

(31.12.2007)

Article 3(2)

ETSI

EN 300 341-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land Mobile service (RP 02); Radio equipment using an integral antenna transmitting signals to initiate a specific response in the receiver; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 373-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Maritime mobile transmitters and receivers for use in the MF and HF bands Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 373-3 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Maritime mobile transmitters and receivers for use in the MF and HF bands Part 3: Harmonised EN covering essential requirements under Article 3(3)(e) of the R & TTE Directive

Article 3(3)

ETSI

EN 300 390-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment intended for the transmission of data (and speech) and using an integral antenna; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

ETS 300 390/A1:1997

Date expired

(30.4.2001)

Article 3(2)

ETSI

EN 300 422-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 422-2 V1.2.2

Electromagnetic compatibility and radio spectrum matters (ERM); Wireless microphones in the 25 MHz to 3 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 422-2 V1.1.1

31.12.2009

Article 3(2)

ETSI

EN 300 433-2 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Double side band (DSB) and/or single side band (SSB) amplitude modulated Citizens’ Band radio equipment; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

EN 300 433-2 V1.1.1

Date expired

(30.9.2002)

Article 3(2)

ETSI

EN 300 440-2 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 300 440-2 V1.1.1

Date expired

(30.6.2007)

Article 3(2)

ETSI

EN 300 440-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 440-2 V1.1.2

28.2.2010

Article 3(2)

ETSI

EN 300 440-2 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 300 440-2 V1.2.1

31.12.2010

Article 3(2)

ETSI

EN 300 454-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Wide band audio links; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 471-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Rules for access and the sharing of common used channels by equipment complying with EN 300 113; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 674-2-1 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Road transport and traffic telematics (RTTT); Dedicated short-range communication (DSRC) transmission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz industrial, scientific and medical (ISM) band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive; Sub-part 1: Requirements for the roadside units (RSU)

Article 3(2)

ETSI

EN 300 674-2-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Road transport and traffic telematics (RTTT); Dedicated short-range communication (DSRC) transmission equipment (500 kbit/s / 250 kbit/s) operating in the 5,8 GHz industrial, scientific and medical (ISM) band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive; Sub-part 2: Requirements for the on-board units (OBU)

Article 3(2)

ETSI

EN 300 698-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 698-3 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radio telephone transmitters and receivers for the maritime mobile service operating in the VHF bands used on inland waterways; Part 3: Harmonised EN covering essential requirements of Article 3(3)(e) of the R & TTE Directive

Article 3(3)

ETSI

EN 300 718-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Avalanche beacons; Transmitter-receiver systems; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 300 718-3 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Avalanche beacons; Transmitter-receiver systems; Part 3: Harmonised EN covering the essential requirements of Article 3(3)(e) of the R & TTE Directive

EN 300 718-3 V1.1.1

Date expired

(30.11.2005)

Article 3(3)

ETSI

EN 300 720-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Ultra-high frequency (UHF) on-board vessels communications systems and equipment; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 300 720-2 V1.1.1

Date expired

(31.7.2009)

Article 3(2)

ETSI

EN 300 761-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Automatic vehicle identification (AVI) for railways operating in the 2,45 GHz frequency range; Part 2: Harmonised standard covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 025-2 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); VHF radiotelephone equipment for general communications and associated equipment for class ‘D’ digital selective calling (DSC); Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 301 025-2 V1.2.1

Date expired

(31.10.2008)

Article 3(2)

ETSI

EN 301 025-3 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); VHF radiotelephone equipment for general communications and associated equipment for Class ‘D’ digital selective calling (DSC); Part 3: Harmonised EN under Article 3(3)(e) of the R & TTE Directive

EN 301 025-3 V1.2.1

Date expired

(31.10.2008)

Article 3(3)

ETSI

EN 301 091-2 V1.3.2

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Radar equipment operating in the 76 GHz to 77 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 091-2 V1.2.1

Date expired

(30.6.2008)

Article 3(2)

ETSI

EN 301 166-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment for analogue and/or digital communication (speech and/or data) and operating on narrow band channels and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 166-2 V1.1.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 301 166-2 V1.2.2

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment for analogue and/or digital communication (speech and/or data) and operating on narrow band channels and having an antenna connector; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 166-2 V1.2.1

31.5.2010

Article 3(2)

ETSI

EN 301 178-2 V1.2.2

Electromagnetic compatibility and radio spectrum matters (ERM); Portable very high frequency (VHF) radiotelephone equipment for the maritime mobile service operating in the VHF bands (for non-GMDSS applications only); Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 178-2 V1.1.1

Date expired

(31.10.2008)

Article 3(2)

ETSI

EN 301 357-2 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Cordless audio devices in the range 25 MHz to 2 000 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 357-2 V1.2.1

Date expired

(30.4.2008)

Article 3(2)

ETSI

EN 301 357-2 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM);Cordless audio devices in the range 25 MHz to 2 000 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 357-2 V1.3.1

31.8.2010

Article 3(2)

ETSI

EN 301 360 V1.2.1

Satellite earth stations and systems (SES); Harmonised EN for satellite interactive terminals (SIT) and satellite user terminals (SUT) transmitting towards geostationary satellites in the 27,5 GHz to 29,5 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 360 V1.1.3

Date expired

(30.11.2007)

Article 3(2)

ETSI

EN 301 406 V1.5.1

Digital enhanced cordless telecommunications (DECT); Harmonised EN for digital enhanced cordless telecommunications (DECT) covering essential requirements under Article 3(2) of the R & TTE Directive; Generic radio

EN 301 406 V1.4.1

Date expired

(31.3.2005)

Article 3(2)

ETSI

EN 301 406 V2.1.1

Digital enhanced cordless telecommunications (DECT); Harmonised EN for digital enhanced cordless telecommunications (DECT) covering the essential requirements under Article 3(2) of the R & TTE Directive; Generic radio

EN 301 406 V1.5.1

30.4.2011

Article 3(2)

ETSI

EN 301 419-1 V4.0.1

Digital cellular telecommunications system (Phase 2); Attachment requirements for global system for mobile communications (GSM); Part 1: Mobile stations in the GSM 900 and DCS 1 800 bands; Access (GSM 13.01 version 4.0.1)

Article 3(2)

ETSI

EN 301 419-2 V5.1.1

Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); High-speed circuit-switched data (HSCSD) multislot mobile stations; Access (GSM 13.34 version 5.1.1 Release 1996)

Article 3(2)

ETSI

EN 301 419-3 V5.0.2

Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); Advanced speech call items (ASCI); Mobile stations; Access (GSM 13.68 version 5.0.2 Release 1996)

Article 3(2)

ETSI

EN 301 419-7 V5.0.2

Digital cellular telecommunications system (Phase 2+); Attachment requirements for global system for mobile communications (GSM); Railways Band (R-GSM); Mobile stations; Access (GSM 13.67 version 5.0.2 Release 1996)

Article 3(2)

ETSI

EN 301 423 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised standard for the terrestrial flight telecommunications system under Article 3(2) of the R & TTE Directive

TBR 23: 1998

Date expired

(30.9.2002)

Article 3(2)

ETSI

EN 301 426 V1.2.1

Satellite earth stations and systems (SES); Harmonised EN for low data rate land mobile satellite earth stations (LMES) and maritime mobile satellite earth stations (MMES) not intended for distress and safety communications operating in the 1,5/1,6 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 426 V1.1.1

Date expired

(30.6.2002)

Article 3(2)

ETSI

EN 301 427 V1.2.1

Satellite earth stations and systems (SES); Harmonised EN for low data rate mobile satellite earth stations (MESs) except aeronautical mobile satellite earth stations, operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 427 V1.1.1

Date expired

(31.8.2003)

Article 3(2)

ETSI

EN 301 428 V1.3.1

Satellite earth stations and systems (SES); Harmonised EN for very small aperture terminal (VSAT); Transmit-only, transmit/receive or receive-only satellite earth stations operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 428 V1.2.1

Date expired

(30.6.2007)

Article 3(2)

ETSI

EN 301 430 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for satellite news gathering transportable earth stations (SNG TES) operating in the 11-12/13-14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

TBR 30: 1998

Date expired

(31.1.2001)

Article 3(2)

ETSI

EN 301 441 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs), including handheld earth stations, for satellite personal communications networks (S-PCN) in the 1,6/2,4 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive

TBR 41: 1998

Date expired

(31.1.2001)

Article 3(2)

ETSI

EN 301 442 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs), including handheld earth stations, for satellite personal communications networks (S-PCN) in the 2,0 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive

TBR 42: 1998

Date expired

(31.1.2001)

Article 3(2)

ETSI

EN 301 443 V1.3.1

Satellite earth stations and systems (SES); Harmonised EN for very small aperture terminal (VSAT); Transmit-only, transmit-and-receive, receive-only satellite earth stations operating in the 4 GHz and 6 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 443 V1.2.1

Date expired

(30.11.2007)

Article 3(2)

ETSI

EN 301 444 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for land mobile earth stations (LMES) operating in the 1,5 GHz and 1,6 GHz bands providing voice and/or data communications covering essential requirements under Article 3(2) of the R & TTE Directive

TBR 44: 1998

Date expired

(31.1.2001)

Article 3(2)

ETSI

EN 301 447 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for satellite earth stations on board vessels (ESVs) operating in the 4/6 GHz frequency bands allocated to the fixed satellite service (FSS) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 449 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum base stations operating in the 450 MHz cellular band (CDMA 450) and 410, 450 and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 459 V1.4.1

Satellite earth stations and systems (SES); Harmonised EN for satellite interactive terminals (SIT) and satellite user terminals (SUT) transmitting towards satellites in geostationary orbit in the 29,5 GHz to 30,0 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 459 V1.3.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 301 489-1 V1.6.1

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

EN 301 489-1 V1.5.1

Date expired

(30.11.2008)

Article 3(1)(b)

ETSI

EN 301 489-1 V1.8.1

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

EN 301 489-1 V1.6.1

31.1.2011

Article 3(1)(b)

ETSI

EN 301 489-10 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 10: Specific conditions for First (CT1 and CT1+) and second generation cordless telephone (CT2) equipment

EN 301 489-10 V1.2.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-11 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 11: Specific conditions for terrestrial sound broadcasting service transmitters

EN 301 489-11 V1.2.1

Date expired

(30.11.2007)

Article 3(1)(b)

ETSI

EN 301 489-12 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 12: Specific conditions for very small aperture terminal, satellite interactive earth stations operated in the frequency ranges between 4 GHz and 30 GHz in the fixed satellite service (FSS)

EN 301 489-12 V1.1.1

Date expired

(31.7.2006)

Article 3(1)(b)

ETSI

EN 301 489-12 V2.2.2

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 12: Specific conditions for very small aperture terminal, satellite interactive earth stations operated in the frequency ranges between 4 GHz and 30 GHz in the fixed satellite service (FSS)

EN 301 489-12 V1.2.1

30.6.2010

Article 3(1)(b)

ETSI

EN 301 489-13 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 13: Specific conditions for Citizens’ Band (CB) radio and ancillary equipment (speech and non-speech)

EN 301 489-13 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-14 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 14: Specific conditions for analogue and digital terrestrial TV broadcasting service transmitters

EN 301 489-14 V1.1.1

Date expired

(31.7.2006)

Article 3(1)(b)

ETSI

EN 301 489-15 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 15: Specific conditions for commercially available amateur radio equipment

EN 301 489-15 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-16 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 16: Specific conditions for analogue cellular radio communications equipment, mobile and portable

EN 301 489-16 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-17 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for 2,4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment

EN 301 489-17 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-17 V1.3.2

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for 2,4 GHz wideband transmission systems, 5 GHz high performance RLAN equipment and 5,8 GHz broadband data transmitting systems

EN 301 489-17 V1.2.1

31.7.2010

Article 3(1)(b)

ETSI

EN 301 489-17 V2.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for broadband data transmission systems

EN 301 489-17 V1.3.2

31.1.2011

Article 3(1)(b)

ETSI

EN 301 489-18 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 18: Specific conditions for terrestrial trunked radio (TETRA) equipment

EN 301 489-18 V1.2.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-19 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 19: Specific conditions for receive only mobile earth stations (ROMES) operating in the 1,5 GHz band providing data communication

EN 301 489-19 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-2 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 2: Specific conditions for radio paging equipment

EN 301 489-02 V1.2.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-20 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 20: Specific conditions for mobile earth stations (MES) used in the mobile satellite services (MSS)

EN 301 489-20 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-22 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 22: Specific requirements for ground-based VHF aeronautical mobile and fixed radio equipment

EN 301 489-22 V1.2.1

Date expired

(28.2.2007)

Article 3(1)(b)

ETSI

EN 301 489-23 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 23: Specific conditions for IMT-2000 CDMA direct spread (UTRA) base station (BS) radio, repeater and ancillary equipment

EN 301 489-23 V1.2.1

Date expired

(31.5.2009)

Article 3(1)(b)

ETSI

EN 301 489-24 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 24: Specific conditions for IMT-2000 CDMA direct spread (UTRA) for mobile and portable (UE) radio and ancillary equipment

EN 301 489-24 V1.3.1

EN 301 489-24 V1.3.1

Date expired

(31.5.2009)

Article 3(1)(b)

ETSI

EN 301 489-25 V2.3.2 (7-2005)

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 25: Specific conditions for CDMA 1x spread spectrum mobile stations and ancillary equipment

EN 301 489-25 V2.2.1

Date expired

(30.4.2007)

Article 3(1)(b)

ETSI

EN 301 489-26 V2.3.2

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 26: Specific conditions for CDMA 1x spread spectrum base stations, repeaters and ancillary equipment

EN 301 489-26 V2.2.1

Date expired

(30.4.2007)

Article 3(1)(b)

ETSI

EN 301 489-27 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for ultra low power active medical implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)

Article 3(1)(b)

ETSI

EN 301 489-28 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 28: Specific conditions for wireless digital video links

Article 3(1)(b)

ETSI

EN 301 489-29 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM);Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for medical data service devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands

Article 3(1)(b)

ETSI

EN 301 489-3 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for short-range devices (SRD) operating on frequencies between 9 kHz and 40 GHz

EN 301 489-03 V1.3.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-31 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for ultra low power active medical implants (ULP-AMI) and related peripheral devices (ULP-AMI-P))

Article 3(1)(b)

ETSI

EN 301 489-32 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 32: Specific conditions for ground and wall probing radar applications

Article 3(1)(b)

ETSI

EN 301 489-33 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM);Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 33: Specific conditions for ultra wide band (UWB) communications devices

Article 3(1)(b)

ETSI

EN 301 489-4 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 4: Specific conditions for fixed radio links and ancillary equipment and services

EN 301 489-04 V1.2.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-4 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 4: Specific conditions for fixed radio links, broadband data transmission system base stations, ancillary equipment and services

EN 301 489-4 V1.3.1

31.1.2011

Article 3(1)(b)

ETSI

EN 301 489-5 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 5: Specific conditions for private land mobile radio (PMR) and ancillary equipment (speech and non-speech)

EN 301 489-05 V1.2.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-6 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 6: Specific conditions for digital enhanced cordless telecommunications (DECT) equipment

EN 301 489-6 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-6 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 6: Specific conditions for digital enhanced cordless telecommunications (DECT) equipment

EN 301 489-6 V1.2.1

31.5.2010

Article 3(1)(b)

ETSI

EN 301 489-7 V1.3.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 7: Specific conditions for mobile and portable radio and ancillary equipment of digital cellular radio telecommunications systems (GSM and DCS)

EN 301 489-07 V1.2.1

Date expired

(31.1.2009)

Article 3(1)(b)

ETSI

EN 301 489-8 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 8: Specific conditions for GSM base stations

EN 301 489-08 V1.1.1

Date expired

(30.11.2005)

Article 3(1)(b)

ETSI

EN 301 489-9 V1.4.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 9: Specific conditions for wireless microphones, similar Radio Frequency (RF) audio link equipment, cordless audio and in-ear monitoring devices

EN 301 489-9 V1.3.1

Date expired

(31.8.2009)

Article 3(1)(b)

ETSI

EN 301 502 V8.1.2

Harmonised EN for global system for mobile communications (GSM); Base Station and Repeater equipment covering essential requirements under Article 3(2) of the R & TTE Directive (GSM 13.21 version 8.0.1 Release 1999)

EN 301 502 V7.0.1

Date expired

(30.4.2002)

Article 3(2)

ETSI

EN 301 511 V9.0.2

Global system for mobile communications (GSM); Harmonised EN for mobile stations in the GSM 900 and GSM 1 800 bands covering essential requirements under Article 3(2) of the R & TTE Directive (1999/5/EC)

EN 301 511 V7.0.1

Date expired

(30.6.2004)

Article 3(2)

ETSI

EN 301 526 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum mobile stations operating in the 450 MHz cellular band (CDMA 450) and 410, 450 and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 681 V1.3.2

Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MESs) of geostationary mobile satellite systems, including handheld earth stations, for satellite personal communications networks (S-PCN) in the 1,5/1,6 GHz bands under the mobile satellite service (MSS) covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 681 V1.2.1

Date expired

(31.3.2006)

Article 3(2)

ETSI

EN 301 721 V1.2.1

Satellite earth stations and systems (SES); Harmonised EN for mobile earth stations (MES) providing low bit rate data communications (LBRDC) using low earth orbiting (LEO) satellites operating below 1 GHz covering essential requirements under Article 3(2) of the R & TTE Directive

EN 301 721 V1.1.1

Date expired

(31.3.2002)

Article 3(2)

ETSI

EN 301 783-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Commercially available amateur radio equipment; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 796 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CT1 and CT1+ cordless telephone equipment covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 797 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CT2 cordless telephone equipment covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 839-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ultra low power active medical implants (ULP-AMI) and peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 839-2 V1.1.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 301 840-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Digital radio microphones operating in the CEPT harmonised band 1 785 MHz to 1 800 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 843-1 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 1: Common technical requirements

EN 301 843-1 V1.1.1

Date expired

(31.3.2006)

Article 3(1)(b)

ETSI

EN 301 843-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 2: Specific conditions for VHF radiotelephone transmitters and receivers

EN 301 843-2 V1.1.1

Date expired

(31.3.2006)

Article 3(1)(b)

ETSI

EN 301 843-4 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 4: Specific conditions for narrow-band direct-printing (NBDP) Navtex receivers

EN 301 843-4 V1.1.1

Date expired

(31.3.2006)

Article 3(1)(b)

ETSI

EN 301 843-5 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 5: Specific conditions for MF/HF radiotelephone transmitters and receivers

Article 3(1)(b)

ETSI

EN 301 843-6 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for marine radio equipment and services; Part 6: Specific conditions for earth stations on board vessels operating in frequency bands above 3 GHz

Article 3(1)(b)

ETSI

EN 301 893 V1.4.1 (3)

Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 893 V1.3.1

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 301 893 V1.5.1

Broadband radio access networks (BRAN);5 GHz high performance RLAN; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 301 893 V1.4.1

30.6.2010

Article 3(2)

ETSI

EN 301 908-1 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 1: Harmonised EN for IMT-2000, introduction and common requirements, covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-01 V2.2.1

Date expired

(31.1.2009)

Article 3(2)

ETSI

EN 301 908-10 V2.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 10: Harmonised EN for IMT-2000, FDMA/TDMA (DECT) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-10 V1.1.1

Date expired

(30.9.2005)

Article 3(2)

ETSI

EN 301 908-10 V4.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), Repeaters and user equipment (UE) for IMT-2000 third-generation cellular networks; Part 10: Harmonised EN for IMT-2000, FDMA/TDMA (DECT) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-10 V2.1.1

30.4.2011

Article 3(2)

ETSI

EN 301 908-11 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 11: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (repeaters) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-11 V2.3.1

Date expired

(31.1.2009)

Article 3(2)

ETSI

EN 301 908-12 V3.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 12: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (repeaters) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 908-2 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 2: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-02 V2.2.1

Date expired

(31.1.2009)

Article 3(2)

ETSI

EN 301 908-3 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 3: Harmonised EN for IMT-2000, CDMA direct spread (UTRA FDD) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-03 V2.2.1

Date expired

(31.1.2009)

Article 3(2)

ETSI

EN 301 908-4 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 4: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-04 V2.2.1

Date expired

(31.5.2009)

Article 3(2)

ETSI

EN 301 908-5 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 5: Harmonised EN for IMT-2000, CDMA multi-carrier (cdma2000) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-05 V2.2.1

Date expired

(31.5.2009)

Article 3(2)

ETSI

EN 301 908-6 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 6: Harmonised EN for IMT-2000, CDMA TDD (UTRA TDD) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-06 V2.2.1

Date expired

(31.5.2009)

Article 3(2)

ETSI

EN 301 908-7 V3.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS), repeaters and user equipment (UE) for IMT-2000 third generation cellular networks; Part 7: Harmonised EN for IMT-2000, CDMA TDD (UTRA TDD) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive

EN 301 908-07 V2.2.2 and EN 301 908-07 V2.2.1

Date expired

(31.1.2009)

Article 3(2)

ETSI

EN 301 908-8 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS) and user equipment (UE) for IMT-2000 third generation cellular networks; Part 8: Harmonised EN for IMT-2000, TDMA single-carrier (UWC 136) (UE) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 908-9 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Base stations (BS) and user equipment (UE) for IMT-2000 third generation cellular networks; Part 9: Harmonised EN for IMT-2000, TDMA single-carrier (UWC 136) (BS) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 301 929-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); VHF transmitters and receivers as coast stations for GMDSS and other applications in the maritime mobile services; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 301 929-2 V1.1.1

Date expired

(30.11.2008)

Article 3(2)

ETSI

EN 301 997-2 V1.1.1

Transmission and Multiplexing (TM); Multipoint equipment; Radio equipment for use in multimedia wireless systems (MWS) in the frequency band 40,5 GHz to 43,5 GHz; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 017-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the amplitude modulated (AM) sound broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 018-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the frequency modulated (FM) sound broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

EN 302 018-2 V1.1.1

Date expired

(30.11.2007)

Article 3(2)

ETSI

EN 302 054-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Meteorological aids (Met Aids); Radiosondes to be used in the 400,15 MHz to 406 MHz frequency range with power levels ranging up to 200 mW; Part 2: Harmonised EN covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 064-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Wireless video links (WVL) operating in the 1,3 GHz to 50 GHz frequency band; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 065 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Ultra wide band (UWB) technologies for communication purposes; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 066-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ground- and wall- probing radar applications; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 066-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Ground- and wall- probing radar applications (GPR/WPR) imaging systems; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 302 066-2 V1.1.1

30.11.2009

Article 3(2)

ETSI

EN 302 077-2 V.1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the terrestrial-digital audio broadcasting (T-DAB) service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 186 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for satellite mobile aircraft earth stations (AESs)operating in the 11/12/14 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 194-2 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Navigation radar used on inland waterways; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 195-2 V1.1.1 (3-2004)

Electromagnetic compatibility and radio spectrum matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for ultra low power active medical implants (ULP-AMI) and accessories; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 208-2 V.1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radio frequency identification equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 208-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radio frequency identification equipment operating in the band 865 MHz to 868 MHz with power levels up to 2 W; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 302 208-2 V1.1.1

31.12.2009

Article 3(2)

ETSI

EN 302 217-2-2 V1.2.3

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2-2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for digital systems operating in frequency bands where frequency coordination is applied

EN 302 217-2-2 V1.1.3

Date expired

(31.5.2009)

Article 3(2)

ETSI

EN 302 217-2-2 V1.3.1

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2-2: Digital systems operating in frequency bands where frequency coordination is applied; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 302 217-2-2 V1.2.3

31.1.2011

Article 3(2)

ETSI

EN 302 217-3 V1.1.3

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 3: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for equipment operating in frequency bands where no frequency coordination is applied

EN 301 751 V1.2.1

Date expired

(31.5.2007)

Article 3(2)

ETSI

EN 302 217-3 V1.2.1

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 3: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for equipment operating in frequency bands where simplified or no frequency coordination procedures are applied

EN 302 217-3 V1.1.3

30.11.2009

Article 3(2)

ETSI

EN 302 217-4-2 V1.3.1

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive for antennas

EN 302 217-4-2 V1.2.1

Date expired

(31.7.2009)

Article 3(2)

ETSI

EN 302 217-4-2 V1.4.1

Fixed radio systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Antennas; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 302 217-4-2 V1.3.1

31.12.2010

Article 3(2)

ETSI

EN 302 245-2 V.1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the digital radio mondiale (DRM) broadcasting service; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 248 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Navigation radar for use on non-SOLAS vessels; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 264-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 77 GHz to 81 GHz band; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 288-2 V1.2.2

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 24 GHz range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 302 288-2 V1.2.1

Date expired

(31.5.2009)

Article 3(2)

ETSI

EN 302 288-2 V1.3.2

Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices; Road transport and traffic telematics (RTTT); Short-range radar equipment operating in the 24 GHz range; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 302 208 V1.2.2

31.10.2010

Article 3(2)

ETSI

EN 302 291-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Close range inductive data communication equipment operating at 13,56 MHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 296 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the digital television broadcast service, Terrestrial (DVB-T); Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 297 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Transmitting equipment for the analogue television broadcasting service; Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 326-2 V1.2.2

Fixed radio systems; Multipoint equipment and antennas; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for digital multipoint radio equipment

EN 302 326-2 V1.1.2

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 302 326-3 V1.2.2

Fixed radio systems; Multipoint equipment and antennas; Part 3: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for multipoint radio antennas

EN 302 326-3 V1.1.2

Date expired

(31.3.2009)

Article 3(2)

ETSI

EN 302 326-3 V1.3.1

Fixed radio systems; Multipoint equipment and antennas; Part 3: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive for multipoint radio antennas

EN 302 326-3 V1.2.2

Date expired

(31.10.2009)

Article 3(2)

ETSI

EN 302 340 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for satellite earth stations on board vessels (ESVs) operating in the 11/12/14 GHz frequency bands allocated to the Fixed Satellite Service (FSS) covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 372-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Equipment for detection and movement; Tanks level probing radar (TLPR) operating in the frequency bands 5,8 GHz, 10 GHz, 25 GHz, 61 GHz and 77 GHz; Part 2: Harmonised EN under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 426 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for CDMA spread spectrum repeaters operating in the 450 MHz cellular band (CDMA450) and the 410 MHz, 450 MHz and 870 MHz PAMR bands (CDMA-PAMR) covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 435-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Technical characteristics for SRD equipment using ultra wide band technology (UWB); Building material analysis and classification equipment applications operating in the frequency band from 2,2 GHz to 8 GHz; Part 2: Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 448 V1.1.1

Satellite earth stations and systems (SES); Harmonised EN for tracking earth stations on trains (ESTs) operating in the 14/12 GHz frequency bands covering essential requirements under Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 454-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Meteorological aids (Met Aids); Radiosondes to be used in the 1 668,4 MHz to 1 690 MHz frequency range; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 480 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Harmonised EN for the GSM onboard aircraft system covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 500-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD) using ultra wide band (UWB) technology; Location tracking equipment operating in the frequency range from 6 GHz to 8,5 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 500-2 V1.2.1

Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices (SRD) using ultra wide band (UWB) technology; Location tracking equipment operating in the frequency range from 6 GHz to 8,5 GHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

EN 302 500-2 V1.1.1

31.3.2010

Article 3(2)

ETSI

EN 302 502 V1.1.1

Broadband radio access networks (BRAN); 5,8 GHz fixed broadband data transmitting systems; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 502 V1.2.1

Broadband radio access networks (BRAN); 5,8 GHz fixed broadband data transmitting systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

EN 302 502 V1.1.1

31.3.2010

Article 3(2)

ETSI

EN 302 510-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for ultra low power active medical membrane implants and accessories; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 536-2 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment in the frequency range 315 kHz to 600 kHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 537-2 V1.1.2

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Ultra low power medical data service systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 2: Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 544-1 V1.1.1

Broadband data transmission systems operating in the 2 500 MHz to 2 690 MHz frequency band; Part 1: TDD base stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 544-2 V1.1.1

Broadband data transmission systems operating in the 2 500 MHz to 2 690 MHz frequency band; Part 2: TDD user equipment stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 561 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Land mobile service; Radio equipment using constant or non-constant envelope modulation operating in a channel bandwidth of 25 kHz, 50 kHz, 100 kHz or 150 kHz; Harmonised EN covering essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 567 V1.1.1

Broadband radio access networks (BRAN); 60 GHz multiple-gigabit WAS/RLAN systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 571 V1.1.1

Intelligent transport systems (ITS); Radiocommunications equipment operating in the 5 855 MHz to 5 925 MHz frequency band; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 608 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM); Short-range devices (SRD); Radio equipment for Eurobalise railway systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 609 V1.1.1

Electromagnetic compatibility and radio spectrum matters (ERM);Short-range devices (SRD); Radio equipment for Euroloop railway systems; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 302 623 V1.1.1

Broadband wireless access systems (BWA) in the 3 400 MHz to 3 800 MHz frequency band; Mobile terminal stations; Harmonised EN covering the essential requirements of Article 3(2) of the R & TTE Directive

Article 3(2)

ETSI

EN 303 035-1 V1.2.1

Terrestrial trunked radio (TETRA); Harmonised EN for TETRA equipment covering essential requirements under Article 3(2) of the R & TTE Directive; Part 1: Voice plus Data (V+D)

EN 303 035-1 V1.1.1

Date expired

(30.9.2003)

Article 3(2)

ETSI

EN 303 035-2 V1.2.2

Terrestrial trunked radio (TETRA); Harmonised EN for TETRA equipment covering essential requirements under Article 3(2) of the R & TTE Directive; Part 2: Direct mode operation (DMO)

EN 303 035-2 V1.2.1

Date expired

(31.10.2004)

Article 3(2)

ETSI

ETS 300 487/A1:1997

Satellite earth stations and systems (SES); Receive-only mobile earth stations (ROMES) operating in the 1,5 GHz band providing data communications; Radio frequency (RF) specifications

Article 3(2)

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European Standards 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 Standards 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 4) 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 4) 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.

Example: For EN 60215:1989, the following applies:

| Cenelec | EN 60215:1989 | | | |
| --- | --- | --- | --- | --- |
| Safety requirements for radio transmitting equipment
  (IEC 60215:1987)

  [The referenced standard is EN 60215:1989] | None

  [There is no superseded standard] | — | Article 3(1)(a) (and Article 2 2006/95/EC) |
| Amendment A1:1992 to EN 60215:1989
  (IEC 60215:1987/A1:1990)

  [The referenced standard is EN 60215:1989


  - A1:1992 to EN 60215:1989] | Note 3

  [The superseded standard is EN 60215:1989] | Date expired
  (1.6.1993) |
| Amendment A2:1994 to EN 60215:1989
  (IEC 60215:1987/A2:1993)

  [The referenced standard is EN 60215:1989


  - A1:1992 to EN 60215:1989


  - A2:1994 to EN 60215:1989] | Note 3

  [The superseded standard is EN 60215:1989 + A1:1992 to EN 60215:1989] | Date expired
  (15.7.1995) |

Cenelec

EN 60215:1989

Safety requirements for radio transmitting equipment

(IEC 60215:1987)

[The referenced standard is EN 60215:1989]

None

[There is no superseded standard]

—

Article 3(1)(a) (and Article 2 2006/95/EC)

Amendment A1:1992 to EN 60215:1989

(IEC 60215:1987/A1:1990)

[The referenced standard is EN 60215:1989

- A1:1992 to EN 60215:1989]

Note 3

[The superseded standard is EN 60215:1989]

Date expired

(1.6.1993)

Amendment A2:1994 to EN 60215:1989

(IEC 60215:1987/A2:1993)

[The referenced standard is EN 60215:1989

- A1:1992 to EN 60215:1989

- A2:1994 to EN 60215:1989]

Note 3

[The superseded standard is EN 60215:1989 + A1:1992 to EN 60215:1989]

Date expired

(15.7.1995)

| Note 4: | EN 301 489-1 contains the common EMC emission and immunity requirements for all radio equipment and must be used together with the appropriate radio part of this standard, to demonstrate presumption of conformity to Article 3(1)(b) of the Directive. |
| --- | --- |

Note 4:

EN 301 489-1 contains the common EMC emission and immunity requirements for all radio equipment and must be used together with the appropriate radio part of this standard, to demonstrate presumption of conformity to Article 3(1)(b) of the Directive.

NOTE:

| — | In addition, standards published under Directives 2006/95/EC, 2004/108/EC, 90/385/EEC and 93/42/EEC may be used to demonstrate compliance with Articles 3(1)(a) and 3(1)(b) of Directive 1999/5/EC. |
| --- | --- |

—

In addition, standards published under Directives 2006/95/EC, 2004/108/EC, 90/385/EEC and 93/42/EEC may be used to demonstrate compliance with Articles 3(1)(a) and 3(1)(b) of Directive 1999/5/EC.

| — | Products are presumed to comply with the Directive when they meet the requirements within the usage conditions for which they are intended. |
| --- | --- |

—

Products are presumed to comply with the Directive when they meet the requirements within the usage conditions for which they are intended.

| — | This list replaces all the previous lists published in the Official Journal of the European Union. |
| --- | --- |

—

This list replaces all the previous lists published in the Official Journal of the European Union.

---

(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu)

Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 5196871, 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.org).

(2)  This version of the standard gives presumption of conformity with the requirements of Article 3(2) of Directive 1999/5/EC under the following condition: The equipment shall implement an adequate spectrum sharing mechanism, e.g. LBT (listen before talk), DAA (detect and avoid), etc., in order to comply with the requirement specified in clause 4.3.5 of this version. Such a mechanism shall facilitate sharing between the various technologies and applications which currently exist and in case of congestion, users will be ensured equal access (and as a consequence a graceful degradation of service to all users)

Harmonised ways for assessing the efficiency of various sharing mechanisms are currently been developed by ETSI in draft EN 300 328 version 1.8.1.

(3)  This version of the standard gives presumption of conformity with the requirements of Article 3(2) of Directive 1999/5/EC under the following additional conditions: The dynamic frequency selection (DFS) mechanism implemented by equipment transmitting in the frequency band 5 600-5 650 MHz, must also be able to detect meteorological radars employing non-constant pulse interval times. These are often referred to as staggered or interleaved PRFs (pulse repetition frequencies) by which up to three different PRF values are used. As of 1 April 2009, the requirement to detect these staggered or interleaved PRFs is extended to the bands 5 250-5 350 MHz and 5 470-5 725 MHz. As of the same date, equipment transmitting in the frequency band 5 600-5 650 MHz must also be able to detect pulse widths down to 0,8 μs and must perform a 10 min CAC (channel availability check) or equivalent to take account of the fact that meteorological radars may perform receive-only noise calibration scans. Harmonised ways for assessing these additional requirements have been proposed by ETSI in draft EN 301 893 v 1.5.1.

---

| 2.12.2009 | EN | Official Journal of the European Union | C 293/34 |
| --- | --- | --- | --- |

2.12.2009

EN

Official Journal of the European Union

C 293/34

---

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

(Text with EEA relevance)

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

2009/C 293/02

| European Standards Organisation (1) | Reference and title of the harmonised standard
  (and reference document) | First publication in the Official Journal | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| CEN | EN 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised 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
  Sterilisation 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 | 31.5.2010 |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | 19.2.2009 | EN 1041:1998
  Note 2.1 | 31.8.2011 |
| CEN | EN ISO 10993-1:2009
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | This is the first publication | EN ISO 10993-1:2003
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-4:2002
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-5:1999
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-6:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-9:2009
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | This is the first publication | EN ISO 10993-9:1999
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-10:2009
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006) | This is the first publication | EN ISO 10993-10:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-11:2009
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | This is the first publication | EN ISO 10993-11:2006
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-12:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-13:2009
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | This is the first publication | EN ISO 10993-13:1998
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-16:2009
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | This is the first publication | EN ISO 10993-16:1997
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-17:2009
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | This is the first publication | EN ISO 10993-17:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-18:2009
  Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) | This is the first publication | EN ISO 10993-18:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11135-1:2007
  Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007) | 9.8.2007 | EN 550:1994
  Note 2.1 | 31.5.2010 |
| CEN | EN ISO 11137-1:2006
  Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation 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
  Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01) | 9.8.2007 | | |
| EN ISO 11137-2:2007/AC:2009 | This is the first publication |
| CEN | EN ISO 11138-2:2009
  Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) | This is the first publication | EN ISO 11138-2:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11138-3:2009
  Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) | This is the first publication | EN ISO 11138-3:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11140-1:2009
  Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | This is the first publication | EN ISO 11140-1:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11607-1:2009
  Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | This is the first publication | EN ISO 11607-1:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11737-1:2006
  Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms 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 | This is the first publication |
| 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:2007 | 9.8.2007 |
| CEN | EN 13824:2004
  Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements | 24.6.2005 | | |
| CEN | EN ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | 11.11.2003 | EN 540:1993
  Note 2.1 | Date expired
  (31.8.2003) |
| CEN | EN ISO 14155-2:2003
  Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) | 11.11.2003 | | |
| CEN | EN ISO 14937:2000
  Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) | 31.7.2002 | | |
| EN ISO 14937:2000/AC:2005 | This is the first publication |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | 9.8.2007 | EN ISO 14971:2000
  Note 2.1 | 31.3.2010 |
| CEN | EN ISO 17665-1:2006
  Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation 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 | | |
| Cenelec | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | 27.8.1998 | | |
| Cenelec | EN 45502-2-1:2003
  Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | 8.7.2004 | | |
| Cenelec | EN 45502-2-2:2008
  Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | 27.11.2008 | | |
| 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 | |
| EN 60601-1:1990/A2:1995
  IEC 60601-1:1988/A2:1995 | 23.8.1996 | Note 3 | |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 | 27.11.2008 | EN 60601-1:1990
  and its amendments
  Note 2.1 | |
| Cenelec | EN 62304:2006
  Medical device software — Software lifecycle processes
  IEC 62304:2006 | 27.11.2008 | | |

European Standards Organisation (1)

Reference and title of the harmonised standard

(and reference document)

First publication in the Official Journal

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 556-1:2001

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

Sterilisation 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

31.5.2010

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

19.2.2009

EN 1041:1998

Note 2.1

31.8.2011

CEN

EN ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

This is the first publication

EN ISO 10993-1:2003

Note 2.1

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)

This is the first publication

EN ISO 10993-4:2002

Note 2.1

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)

This is the first publication

EN ISO 10993-5:1999

Note 2.1

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)

This is the first publication

EN ISO 10993-6:2007

Note 2.1

21.3.2010

CEN

EN ISO 10993-9:2009

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

This is the first publication

EN ISO 10993-9:1999

Note 2.1

21.3.2010

CEN

EN ISO 10993-10:2009

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

This is the first publication

EN ISO 10993-10:2002

Note 2.1

21.3.2010

CEN

EN ISO 10993-11:2009

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

This is the first publication

EN ISO 10993-11:2006

Note 2.1

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)

This is the first publication

EN ISO 10993-12:2007

Note 2.1

21.3.2010

CEN

EN ISO 10993-13:2009

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

This is the first publication

EN ISO 10993-13:1998

Note 2.1

21.3.2010

CEN

EN ISO 10993-16:2009

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

This is the first publication

EN ISO 10993-16:1997

Note 2.1

21.3.2010

CEN

EN ISO 10993-17:2009

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

This is the first publication

EN ISO 10993-17:2002

Note 2.1

21.3.2010

CEN

EN ISO 10993-18:2009

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

This is the first publication

EN ISO 10993-18:2005

Note 2.1

21.3.2010

CEN

EN ISO 11135-1:2007

Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007)

9.8.2007

EN 550:1994

Note 2.1

31.5.2010

CEN

EN ISO 11137-1:2006

Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation 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

Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01)

9.8.2007

EN ISO 11137-2:2007/AC:2009

This is the first publication

CEN

EN ISO 11138-2:2009

Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006)

This is the first publication

EN ISO 11138-2:2006

Note 2.1

21.3.2010

CEN

EN ISO 11138-3:2009

Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006)

This is the first publication

EN ISO 11138-3:2006

Note 2.1

21.3.2010

CEN

EN ISO 11140-1:2009

Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

This is the first publication

EN ISO 11140-1:2005

Note 2.1

21.3.2010

CEN

EN ISO 11607-1:2009

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

This is the first publication

EN ISO 11607-1:2006

Note 2.1

21.3.2010

CEN

EN ISO 11737-1:2006

Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms 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

This is the first publication

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:2007

9.8.2007

CEN

EN 13824:2004

Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements

24.6.2005

CEN

EN ISO 14155-1:2003

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

11.11.2003

EN 540:1993

Note 2.1

Date expired

(31.8.2003)

CEN

EN ISO 14155-2:2003

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

11.11.2003

CEN

EN ISO 14937:2000

Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000)

31.7.2002

EN ISO 14937:2000/AC:2005

This is the first publication

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

9.8.2007

EN ISO 14971:2000

Note 2.1

31.3.2010

CEN

EN ISO 17665-1:2006

Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation 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

Cenelec

EN 45502-1:1997

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

27.8.1998

Cenelec

EN 45502-2-1:2003

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

8.7.2004

Cenelec

EN 45502-2-2:2008

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

27.11.2008

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

EN 60601-1:1990/A2:1995

IEC 60601-1:1988/A2:1995

23.8.1996

Note 3

Cenelec

EN 60601-1:2006

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

IEC 60601-1:2005

27.11.2008

EN 60601-1:1990

and its amendments

Note 2.1

Cenelec

EN 62304:2006

Medical device software — Software lifecycle processes

IEC 62304:2006

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 of the 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 of the Council (2) amended by the Directive 98/48/EC (3).

| — | 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/newapproach/standardization/harmstds/ |
| --- | --- |

—

More information about harmonised standards on the Internet at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

---

(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu).

Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, 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).

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

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

---

| 2.12.2009 | EN | Official Journal of the European Union | C 293/39 |
| --- | --- | --- | --- |

2.12.2009

EN

Official Journal of the European Union

C 293/39

---

Commission communication in the framework of the implementation of 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)

2009/C 293/03

| European Standards Organisation (1) | Reference and title of the harmonised standard
  (and reference document) | First publication in the Official Journal | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| CEN | EN 285:2006 + A2:2009
  Sterilisation — Steam sterilisers — Large sterilisers | This is the first publication | EN 285:2006 + A1:2008
  EN 285:2006
  Note 2.1 | 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 455-2:2000
  Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) | 31.7.2002 | EN 455-2:1995
  Note 2.1 | Date expired
  (30.4.2001) |
| 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 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised 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
  Sterilisation 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 | This is the first publication | EN 794-1:1997
  Note 2.1 | 21.3.2010 |
| CEN | EN 794-3:1998
  Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators | 28.6.1999 | | |
| EN 794-3:1998/A1:2005 | 2.6.2006 | Note 3 | Date expired
  (31.12.2005) |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | 31.5.2010 |
| CEN | EN 1041:2008
  Information supplied by the manufacturer of medical devices | 19.2.2009 | EN 1041:1998
  Note 2.1 | 31.8.2011 |
| CEN | EN 1060-1:1995
  Non-invasive sphygmomanometers — Part 1: General requirements | 23.8.1996 | | |
| EN 1060-1:1995/A1:2002 | 30.9.2005 | Note 3 | Date expired
  (30.11.2002) |
| CEN | EN 1060-2:1995
  Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers | 26.8.1996 | | |
| EN 1060-2:1995/AC:2002 | This is the first publication |
| CEN | EN 1060-3:1997
  Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | 9.5.1998 | | |
| EN 1060-3:1997/A1:2005 | 2.6.2006 | Note 3 | Date expired
  (30.6.2006) |
| 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 1282-2:2005
  Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) | 30.9.2005 | EN 1282-2:1997
  Note 2.1 | Date expired
  (31.12.2005) |
| CEN | EN 1422:1997 + A1:2009
  Sterilisers for medical purposes — Ethylene oxide sterilisers — Requirements and test methods | This is the first publication | EN 1422:1997
  Note 2.1 | 21.3.2010 |
| CEN | EN 1618:1997
  Catheters other than intravascular catheters — Test methods for common properties | 9.5.1998 | | |
| CEN | EN 1639:2004
  Dentistry — Medical devices for dentistry — Instruments | 30.9.2005 | EN 1639:1996
  Note 2.1 | Date expired
  (31.12.2004) |
| CEN | EN 1640:2004
  Dentistry — Medical devices for dentistry — Equipment | 30.9.2005 | EN 1640:1996
  Note 2.1 | Date expired
  (31.12.2004) |
| CEN | EN 1641:2004
  Dentistry — Medical devices for dentistry — Materials | 30.9.2005 | EN 1641:1996
  Note 2.1 | Date expired
  (31.12.2004) |
| CEN | EN 1642:2004
  Dentistry — Medical devices for dentistry — Dental implants | 30.9.2005 | EN 1642:1996
  Note 2.1 | Date expired
  (31.12.2004) |
| 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
  Tracheal tubes and connectors | 30.9.2005 | | |
| CEN | EN 1789:2007
  Medical vehicles and their equipment — Road ambulances | 23.7.2008 | EN 1789:1999
  Note 2.1 | Date expired
  (30.11.2007) |
| CEN | EN 1820:2005
  Anaesthetic reservoir bags (ISO 5362:2000, modified) | 30.9.2005 | EN 1820:1997
  Note 2.1 | Date expired
  (31.12.2005) |
| CEN | EN 1865:1999
  Specifications for stretchers and other patient handling equipment used in road ambulances | 14.10.2000 | | |
| CEN | EN 1970:2000
  Adjustable beds for disabled persons — Requirements and test methods | 14.11.2001 | | |
| EN 1970:2000/A1:2005 | 30.9.2005 | Note 3 | Date expired
  (30.9.2005) |
| CEN | EN 1985:1998
  Walking aids — General requirements and test methods | 10.8.1999 | | |
| 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 | This is the first publication |
| 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 | 30.6.2010 |
| CEN | EN ISO 5360:2009
  Anaesthetic vaporisers — Agent-specific filling systems (ISO 5360:2006) | This is the first publication | EN ISO 5360:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 5366-1:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 5840:2009
  Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) | This is the first publication | EN ISO 5840:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 7197:2009
  Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) | This is the first publication | EN ISO 7197:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 7376:2009
  Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003) | This is the first publication | EN ISO 7376:2003
  Note 2.1 | 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) |
| 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) | This is the first publication | EN ISO 7439:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 7886-3:2005
  Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunisation (ISO 7886-3:2005) | 30.9.2005 | | |
| CEN | EN ISO 7886-4:2006
  Sterile hypodermic syringes for single use — Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006) | 9.8.2007 | | |
| CEN | EN ISO 8185:2009
  Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007) | This is the first publication | EN ISO 8185:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 8359:2009
  Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) | This is the first publication | EN ISO 8359:1996
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 8536-4:2007
  Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007) | 9.8.2007 | | |
| CEN | EN ISO 8835-2:2009
  Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) | This is the first publication | EN ISO 8835-2:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 8835-3:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 8835-4:2009
  Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) | This is the first publication | EN ISO 8835-4:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 8835-5:2009
  Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004) | This is the first publication | EN ISO 8835-5:2004
  Note 2.1 | 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 | 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 | 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) | This is the first publication | EN ISO 9360-1:2000
  Note 2.1 | 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 tracheostomised patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) | This is the first publication | EN ISO 9360-2:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 9713:2009
  Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) | This is the first publication | EN ISO 9713:2004
  Note 2.1 | 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) | This is the first publication | EN ISO 9919:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10079-1:2009
  Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) | This is the first publication | EN ISO 10079-1:1999
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10079-2:2009
  Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) | This is the first publication | EN ISO 10079-2:1999
  Note 2.1 | 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) | This is the first publication | EN ISO 10079-3:1999
  Note 2.1 | 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 | | |
| 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 | 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) |
| 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) | This is the first publication | EN ISO 10555-1:1996
  Note 2.1 | 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) | This is the first publication | EN ISO 10651-2:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10651-4:2009
  Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | This is the first publication | EN ISO 10651-4:2002
  Note 2.1 | 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) | This is the first publication | EN ISO 10651-6:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-1:2009
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | This is the first publication | EN ISO 10993-1:2003
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-3:2009
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) | This is the first publication | EN ISO 10993-3:2003
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-4:2002
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-5:1999
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-6:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-7:2008
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilisation residuals (ISO 10993-7:2008) | 19.2.2009 | | |
| CEN | EN ISO 10993-9:2009
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | This is the first publication | EN ISO 10993-9:1999
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-10:2009
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006) | This is the first publication | EN ISO 10993-10:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-11:2009
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | This is the first publication | EN ISO 10993-11:2006
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-12:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-13:2009
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | This is the first publication | EN ISO 10993-13:1998
  Note 2.1 | 21.3.2010 |
| 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) | This is the first publication | EN ISO 10993-14:2001
  Note 2.1 | 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) | This is the first publication | EN ISO 10993-15:2000
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-16:2009
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | This is the first publication | EN ISO 10993-16:1997
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-17:2009
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | This is the first publication | EN ISO 10993-17:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 10993-18:2009
  Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) | This is the first publication | EN ISO 10993-18:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11135-1:2007
  Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007) | 9.8.2007 | EN 550:1994
  Note 2.1 | 31.5.2010 |
| CEN | EN ISO 11137-1:2006
  Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation 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
  Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01) | 9.8.2007 | | |
| EN ISO 11137-2:2007/AC:2009 | This is the first publication |
| CEN | EN ISO 11138-2:2009
  Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) | This is the first publication | EN ISO 11138-2:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11138-3:2009
  Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) | This is the first publication | EN ISO 11138-3:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11140-1:2009
  Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | This is the first publication | EN ISO 11140-1:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11140-3:2009
  Sterilisation of healthcare 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) | This is the first publication | EN ISO 11140-3:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11197:2009
  Medical supply units (ISO 11197:2004) | This is the first publication | EN ISO 11197:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11607-1:2009
  Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | This is the first publication | EN ISO 11607-1:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11607-2:2006
  Packaging for terminally sterilised 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
  Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms 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 | This is the first publication |
| 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) | This is the first publication | | |
| 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) | This is the first publication | EN ISO 11810-2:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 11979-8:2009
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) | This is the first publication | EN ISO 11979-8:2006
  Note 2.1 | 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 | This is the first publication | EN 12006-2:1998
  Note 2.1 | 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 | This is the first publication | EN 12006-3:1998
  Note 2.1 | 21.3.2010 |
| CEN | EN 12182:1999
  Technical aids for disabled persons — General requirements and test methods | 14.10.2000 | | |
| CEN | EN 12342:1998
  Breathing tubes intended for use with anaesthetic apparatus and ventilators | 26.6.1999 | | |
| CEN | EN 12470-1:2000 + A1:2009
  Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device | This is the first publication | EN 12470-1:2000
  Note 2.1 | 21.3.2010 |
| CEN | EN 12470-2:2000 + A1:2009
  Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers | This is the first publication | EN 12470-2:2000
  Note 2.1 | 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 | This is the first publication | EN 12470-3:2000
  Note 2.1 | 21.3.2010 |
| CEN | EN 12470-4:2000 + A1:2009
  Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement | This is the first publication | EN 12470-4:2000
  Note 2.1 | 21.3.2010 |
| CEN | EN 12470-5:2003
  Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device) | 7.11.2003 | | |
| CEN | EN ISO 12870:2009
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) | This is the first publication | EN ISO 12870:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN 13060:2004 + A1:2009
  Small steam sterilisers | This is the first publication | EN 13060:2004
  Note 2.1 | 21.3.2010 |
| 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:2007 | 9.8.2007 |
| CEN | EN 13544-1:2007
  Respiratory therapy equipment — Part 1: Nebulising systems and their components | 9.8.2007 | EN 13544-1:2001
  Note 2.1 | Date expired
  (31.10.2007) |
| CEN | EN 13544-2:2002
  Respiratory therapy equipment — Part 2: Tubing and connectors | 21.12.2002 | | |
| CEN | EN 13544-3:2001
  Respiratory therapy equipment — Part 3: Air entrainment devices | 30.9.2005 | | |
| 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 | This is the first publication |
| 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
  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 | 19.2.2009 | | |
| CEN | EN 13795-2:2004
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods | 19.2.2009 | | |
| CEN | EN 13795-3:2006
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels | 19.2.2009 | | |
| CEN | EN 13824:2004
  Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements | 30.9.2005 | | |
| CEN | EN 13867:2002 + A1:2009
  Concentrates for haemodialysis and related therapies | This is the first publication | EN 13867:2002
  Note 2.1 | 21.3.2010 |
| CEN | EN 13976-1:2003
  Rescue systems — Transportation of incubators — Part 1: Interface conditions | 30.9.2005 | | |
| CEN | EN 13976-2:2003
  Rescue systems — Transportation of incubators — Part 2: System requirements | 30.9.2005 | | |
| EN 13976-2:2003/AC:2004 | This is the first publication |
| 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 ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | 11.11.2003 | EN 540:1993
  Note 2.1 | Date expired
  (31.8.2003) |
| CEN | EN ISO 14155-2:2003
  Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) | 11.11.2003 | | |
| CEN | EN ISO 14160:1998
  Sterilisation of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilisation by liquid chemical sterilants (ISO 14160:1998) | 27.8.1998 | | |
| CEN | EN 14180:2003 + A1:2009
  Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — Requirements and testing | This is the first publication | EN 14180:2003
  Note 2.1 | 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) | This is the first publication | EN ISO 14408:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 14534:2009
  Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002) | This is the first publication | EN ISO 14534:2002
  Note 2.1 | 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 14602:2009
  Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:1998) | This is the first publication | EN ISO 14602:1998
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 14607:2009
  Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007) | This is the first publication | EN ISO 14607:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 14630:2009
  Non-active surgical implants — General requirements (ISO 14630:2008) | This is the first publication | EN ISO 14630:2008
  Note 2.1 | 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) | This is the first publication | EN ISO 14889:2003
  Note 2.1 | 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 14937:2000
  Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) | 31.7.2002 | | |
| EN ISO 14937:2000/AC:2005 | This is the first publication |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | 9.8.2007 | EN ISO 14971:2000
  Note 2.1 | 31.3.2010 |
| CEN | EN ISO 15001:2004
  Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003) | 30.9.2005 | | |
| 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 | 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) | This is the first publication | EN ISO 15004-1:2006
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | 31.7.2002 | | |
| EN ISO 15225:2000/A1:2004 | 30.9.2005 | Note 3 | Date expired
  (31.8.2004) |
| EN ISO 15225:2000/A2:2005 | This is the first publication | Note 3 | Date expired
  (31.1.2006) |
| CEN | EN 15424:2007
  Sterilisation of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilisation process for medical devices | 9.8.2007 | | |
| CEN | EN 15546-1:2008
  Small bore connectors for liquids and gases in healthcare applications — Part 1 — General Requirements | 23.7.2008 | | |
| CEN | EN ISO 15747:2005
  Plastics containers for intravenous injection (ISO 15747:2003) | 30.9.2005 | | |
| CEN | EN ISO 15883-1:2009
  Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) | This is the first publication | EN ISO 15883-1:2006
  Note 2.1 | 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) | This is the first publication | EN ISO 15883-2:2006
  Note 2.1 | 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) | This is the first publication | EN ISO 15883-3:2006
  Note 2.1 | 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) | This is the first publication | EN ISO 15883-4:2008
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 16061:2008
  Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008) | 19.2.2009 | EN 12011:1998
  Note 2.1 | Date expired
  (30.6.2009) |
| 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) | This is the first publication | EN ISO 17510-1:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 17510-2:2009
  Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007) | This is the first publication | EN ISO 17510-2:2007
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 17664:2004
  Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of re-sterilisable medical devices (ISO 17664:2004) | 30.9.2005 | | |
| CEN | EN ISO 17665-1:2006
  Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation 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) | This is the first publication | EN ISO 18777:2005
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 18778:2009
  Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) | This is the first publication | EN ISO 18778:2005
  Note 2.1 | 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 | This is the first publication | | |
| 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) | This is the first publication | EN ISO 21534:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 21535:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 21536:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 21647:2004
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 21649:2006
  Needle-free injectors for medical use — Requirements and test methods (ISO 21649:2006) | 7.9.2006 | | |
| CEN | EN ISO 21969:2006
  High-pressure flexible connections for use with medical gas systems (ISO 21969:2005) | 7.9.2006 | EN 13221:2000
  Note 2.1 | Date expired
  (31.12.2007) |
| CEN | EN ISO 22442-1:2007
  Medical devices utilising 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 utilising 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 utilising 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) |
| 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 | | |
| 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) | This is the first publication | EN ISO 23328-2:2008
  Note 2.1 | 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) | This is the first publication | EN ISO 23747:2007
  Note 2.1 | 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) | This is the first publication | EN ISO 25539-1:2008
  Note 2.1 | 21.3.2010 |
| CEN | EN ISO 25539-2:2009
  Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008) | This is the first publication | EN ISO 25539-2:2008
  Note 2.1 | 21.3.2010 |
| 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 | This is the first publication | | |
| Cenelec | EN 60118-13:2005
  Electroacoustics — Hearing aids — Part 13: Electromagnetic compatibility (EMC)
  IEC 60118-13:2004 | 19.1.2006 | EN 60118-13:1997
  Note 2.1 | Date expired
  (1.2.2008) |
| Cenelec | EN 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies
  IEC 60522:1999 | 14.11.2001 | | |
| Cenelec | EN 60580:2000
  Medical electrical equipment — Dose area product meters
  IEC 60580:2000 | 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 |
| EN 60601-1:1990/A2:1995
  IEC 60601-1:1988/A2:1995 | 18.11.1995 | Note 3 |
| Cenelec | EN 60601-1:2006
  Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
  IEC 60601-1:2005 | 27.11.2008 | EN 60601-1:1990
  and its amendments
  Note 2.1 | |
| Cenelec | EN 60601-1-1:2001
  Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
  IEC 60601-1-1:2000 | 14.11.2001 | EN 60601-1-1:1993
  - A1:1996
  Note 2.1 | Date expired
  (1.12.2003) |
| 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 | 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) | 27.11.2008 | EN 60601-1-2:2001
  and its amendment
  Note 2.1 | |
| 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 | 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 | 27.11.2008 | EN 60601-1-3:1994
  Note 2.1 | Date expired
  (1.7.1995) |
| Cenelec | EN 60601-1-4:1996
  Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems
  IEC 60601-1-4:1996 | 8.11.1997 | | |
| EN 60601-1-4:1996/A1:1999
  IEC 60601-1-4:1996/A1:1999 | 8.11.1997 | Note 3 | Date expired
  (1.12.2002) |
| Cenelec | EN 60601-1-6:2004
  Medical electrical equipment — Part 1-6: General requirements for safety — Collateral standard: Usability
  IEC 60601-1-6:2004 | 2.7.2006 | | |
| 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 | 27.11.2008 | EN 60601-1-6:2004
  Note 2.1 | |
| 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 | 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 | 27.11.2008 | EN 60601-1-8:2004
  and its amendment
  Note 2.1 | |
| Cenelec | EN 60601-1-10:2008
  Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  IEC 60601-1-10:2007 | 27.11.2008 | | |
| Cenelec | EN 60601-2-1:1998
  Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
  IEC 60601-2-1:1998 | 14.11.2001 | | |
| EN 60601-2-1:1998/A1:2002
  IEC 60601-2-1:1998/A1:2002 | 13.12.2002 | Note 3 | Date expired
  (1.6.2005) |
| Cenelec | EN 60601-2-2:2000
  Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
  IEC 60601-2-2:1998 | 13.12.2002 | EN 60601-2-2:1993
  Note 2.1 | Date expired
  (1.8.2003) |
| 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 | 22.12.2007 | EN 60601-2-2:2000
  Note 2.1 | Date expired
  (1.10.2009) |
| Cenelec | EN 60601-2-3:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment
  IEC 60601-2-3:1991 | 18.11.1995 | | |
| EN 60601-2-3:1993/A1:1998
  IEC 60601-2-3:1991/A1:1998 | 18.11.1995 | Note 3 | Date expired
  (1.7.2001) |
| Cenelec | EN 60601-2-4:2003
  Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators
  IEC 60601-2-4:2002 | 15.10.2003 | | |
| Cenelec | EN 60601-2-5:2000
  Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
  IEC 60601-2-5:2000 | 13.12.2002 | | |
| 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 | 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 | 14.11.2001 | Note 3 | Date expired
  (1.6.1998) |
| 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 | 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 | 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 | 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 | 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 | 9.10.1999 | | |
| Cenelec | EN 60601-2-17:2004
  Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
  IEC 60601-2-17:2004 | 8.11.2005 | 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 | 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 | 9.10.1999 | Note 3 | Date expired
  (13.6.1998) |
| 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 | 9.10.1999 | | |
| 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 | 23.8.2006 | Note 3 | Date expired
  (13.6.1998) |
| Cenelec | EN 60601-2-22:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
  IEC 60601-2-22:1995 | 17.5.1997 | | |
| Cenelec | EN 60601-2-23:2000
  Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
  IEC 60601-2-23:1999 | 14.11.2001 | 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 | 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 | 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 | 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 | 26.7.2006 | EN 60601-2-27:1994
  Note 2.1 | Date expired
  (1.11.2008) |
| 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 | 18.11.1995 | | |
| 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 | 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 | 15.7.2009 | EN 60601-2-29:1999
  Note 2.1 | 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 | 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 | 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 | 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 | 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 | 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 | 9.10.1999 | | |
| Cenelec | EN 60601-2-36:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  IEC 60601-2-36:1997 | 9.10.1999 | | |
| Cenelec | EN 60601-2-37:2001
  Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
  IEC 60601-2-37:2001 | 13.12.2002 | | |
| EN 60601-2-37:2001/A1:2005
  IEC 60601-2-37:2001/A1:2004 | 8.11.2005 | Note 3 | Date expired
  (1.1.2008) |
| EN 60601-2-37:2001/A2:2005
  IEC 60601-2-37:2001/A2:2005 | 26.7.2006 | Note 3 | Date expired
  (1.12.2008) |
| Cenelec | EN 60601-2-37:2008
  Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  IEC 60601-2-37:2007 | 27.11.2008 | EN 60601-2-37:2001
  and its amendments
  Note 2.1 | 1.10.2010 |
| 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 | 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 | 14.11.2001 | | |
| Cenelec | EN 60601-2-39:2008
  Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
  IEC 60601-2-39:2007 | 27.11.2008 | EN 60601-2-39:1999
  Note 2.1 | 1.3.2011 |
| Cenelec | EN 60601-2-40:1998
  Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
  IEC 60601-2-40:1998 | 9.10.1999 | | |
| 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 | 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 | 13.12.2002 | | |
| 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 | 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 | 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 | 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 | 13.12.2002 | | |
| Cenelec | EN 60601-2-49:2001
  Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
  IEC 60601-2-49:2001 | 13.12.2002 | | |
| 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 | 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 | 24.6.2004 | | |
| Cenelec | EN 60627:2001
  Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids
  IEC 60627:2001 | 13.12.2002 | | |
| Cenelec | EN 60645-1:2001
  Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers
  IEC 60645-1:2001 | 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 | 17.5.1997 | | |
| Cenelec | EN 60645-3:1995
  Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
  IEC 60645-3:1994 | 23.8.1996 | | |
| Cenelec | EN 60645-3:2007
  Electroacoustics — Audiometric equipment — Part 3: Test signals of short duration
  IEC 60645-3:2007 | 27.11.2008 | EN 60645-3:1995
  Note 2.1 | 1.6.2010 |
| Cenelec | EN 60645-4:1995
  Audiometers — Part 4: Equipment for extended high-frequency audiometry
  IEC 60645-4:1994 | 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 | 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 | | |
| Cenelec | EN 62083:2001
  Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
  IEC 62083:2000 | 13.12.2002 | | |
| Cenelec | EN 62220-1:2004
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency
  IEC 62220-1:2003 | 24.6.2004 | | |
| Cenelec | EN 62220-1-2:2007
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography
  IEC 62220-1-2:2007 | 27.11.2008 | | |
| Cenelec | EN 62220-1-3:2008
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-3: Determination of the detective quantum efficiency — Detectors used in dynamic imaging
  IEC 62220-1-3:2008 | 15.7.2009 | | |
| Cenelec | EN 62304:2006
  Medical device software — Software lifecycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  IEC 62366:2007 | 27.11.2008 | | |

European Standards Organisation (1)

Reference and title of the harmonised standard

(and reference document)

First publication in the Official Journal

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 285:2006 + A2:2009

Sterilisation — Steam sterilisers — Large sterilisers

This is the first publication

EN 285:2006 + A1:2008

EN 285:2006

Note 2.1

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 455-2:2000

Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)

31.7.2002

EN 455-2:1995

Note 2.1

Date expired

(30.4.2001)

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 556-1:2001

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

Sterilisation 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

This is the first publication

EN 794-1:1997

Note 2.1

21.3.2010

CEN

EN 794-3:1998

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

28.6.1999

EN 794-3:1998/A1:2005

2.6.2006

Note 3

Date expired

(31.12.2005)

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

31.5.2010

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

19.2.2009

EN 1041:1998

Note 2.1

31.8.2011

CEN

EN 1060-1:1995

Non-invasive sphygmomanometers — Part 1: General requirements

23.8.1996

EN 1060-1:1995/A1:2002

30.9.2005

Note 3

Date expired

(30.11.2002)

CEN

EN 1060-2:1995

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

26.8.1996

EN 1060-2:1995/AC:2002

This is the first publication

CEN

EN 1060-3:1997

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

9.5.1998

EN 1060-3:1997/A1:2005

2.6.2006

Note 3

Date expired

(30.6.2006)

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 1282-2:2005

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

30.9.2005

EN 1282-2:1997

Note 2.1

Date expired

(31.12.2005)

CEN

EN 1422:1997 + A1:2009

Sterilisers for medical purposes — Ethylene oxide sterilisers — Requirements and test methods

This is the first publication

EN 1422:1997

Note 2.1

21.3.2010

CEN

EN 1618:1997

Catheters other than intravascular catheters — Test methods for common properties

9.5.1998

CEN

EN 1639:2004

Dentistry — Medical devices for dentistry — Instruments

30.9.2005

EN 1639:1996

Note 2.1

Date expired

(31.12.2004)

CEN

EN 1640:2004

Dentistry — Medical devices for dentistry — Equipment

30.9.2005

EN 1640:1996

Note 2.1

Date expired

(31.12.2004)

CEN

EN 1641:2004

Dentistry — Medical devices for dentistry — Materials

30.9.2005

EN 1641:1996

Note 2.1

Date expired

(31.12.2004)

CEN

EN 1642:2004

Dentistry — Medical devices for dentistry — Dental implants

30.9.2005

EN 1642:1996

Note 2.1

Date expired

(31.12.2004)

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

Tracheal tubes and connectors

30.9.2005

CEN

EN 1789:2007

Medical vehicles and their equipment — Road ambulances

23.7.2008

EN 1789:1999

Note 2.1

Date expired

(30.11.2007)

CEN

EN 1820:2005

Anaesthetic reservoir bags (ISO 5362:2000, modified)

30.9.2005

EN 1820:1997

Note 2.1

Date expired

(31.12.2005)

CEN

EN 1865:1999

Specifications for stretchers and other patient handling equipment used in road ambulances

14.10.2000

CEN

EN 1970:2000

Adjustable beds for disabled persons — Requirements and test methods

14.11.2001

EN 1970:2000/A1:2005

30.9.2005

Note 3

Date expired

(30.9.2005)

CEN

EN 1985:1998

Walking aids — General requirements and test methods

10.8.1999

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

This is the first publication

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

30.6.2010

CEN

EN ISO 5360:2009

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

This is the first publication

EN ISO 5360:2007

Note 2.1

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)

This is the first publication

EN ISO 5366-1:2004

Note 2.1

21.3.2010

CEN

EN ISO 5840:2009

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

This is the first publication

EN ISO 5840:2005

Note 2.1

21.3.2010

CEN

EN ISO 7197:2009

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

This is the first publication

EN ISO 7197:2006

Note 2.1

21.3.2010

CEN

EN ISO 7376:2009

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003)

This is the first publication

EN ISO 7376:2003

Note 2.1

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)

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)

This is the first publication

EN ISO 7439:2002

Note 2.1

21.3.2010

CEN

EN ISO 7886-3:2005

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

30.9.2005

CEN

EN ISO 7886-4:2006

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

9.8.2007

CEN

EN ISO 8185:2009

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

This is the first publication

EN ISO 8185:2007

Note 2.1

21.3.2010

CEN

EN ISO 8359:2009

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

This is the first publication

EN ISO 8359:1996

Note 2.1

21.3.2010

CEN

EN ISO 8536-4:2007

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)

9.8.2007

CEN

EN ISO 8835-2:2009

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

This is the first publication

EN ISO 8835-2:2007

Note 2.1

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)

This is the first publication

EN ISO 8835-3:2007

Note 2.1

21.3.2010

CEN

EN ISO 8835-4:2009

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

This is the first publication

EN ISO 8835-4:2004

Note 2.1

21.3.2010

CEN

EN ISO 8835-5:2009

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

This is the first publication

EN ISO 8835-5:2004

Note 2.1

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

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

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)

This is the first publication

EN ISO 9360-1:2000

Note 2.1

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 tracheostomised patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

This is the first publication

EN ISO 9360-2:2002

Note 2.1

21.3.2010

CEN

EN ISO 9713:2009

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

This is the first publication

EN ISO 9713:2004

Note 2.1

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)

This is the first publication

EN ISO 9919:2005

Note 2.1

21.3.2010

CEN

EN ISO 10079-1:2009

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

This is the first publication

EN ISO 10079-1:1999

Note 2.1

21.3.2010

CEN

EN ISO 10079-2:2009

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

This is the first publication

EN ISO 10079-2:1999

Note 2.1

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)

This is the first publication

EN ISO 10079-3:1999

Note 2.1

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

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

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)

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)

This is the first publication

EN ISO 10555-1:1996

Note 2.1

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)

This is the first publication

EN ISO 10651-2:2004

Note 2.1

21.3.2010

CEN

EN ISO 10651-4:2009

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

This is the first publication

EN ISO 10651-4:2002

Note 2.1

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)

This is the first publication

EN ISO 10651-6:2004

Note 2.1

21.3.2010

CEN

EN ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

This is the first publication

EN ISO 10993-1:2003

Note 2.1

21.3.2010

CEN

EN ISO 10993-3:2009

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

This is the first publication

EN ISO 10993-3:2003

Note 2.1

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)

This is the first publication

EN ISO 10993-4:2002

Note 2.1

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)

This is the first publication

EN ISO 10993-5:1999

Note 2.1

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)

This is the first publication

EN ISO 10993-6:2007

Note 2.1

21.3.2010

CEN

EN ISO 10993-7:2008

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

19.2.2009

CEN

EN ISO 10993-9:2009

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

This is the first publication

EN ISO 10993-9:1999

Note 2.1

21.3.2010

CEN

EN ISO 10993-10:2009

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

This is the first publication

EN ISO 10993-10:2002

Note 2.1

21.3.2010

CEN

EN ISO 10993-11:2009

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

This is the first publication

EN ISO 10993-11:2006

Note 2.1

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)

This is the first publication

EN ISO 10993-12:2007

Note 2.1

21.3.2010

CEN

EN ISO 10993-13:2009

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

This is the first publication

EN ISO 10993-13:1998

Note 2.1

21.3.2010

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)

This is the first publication

EN ISO 10993-14:2001

Note 2.1

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)

This is the first publication

EN ISO 10993-15:2000

Note 2.1

21.3.2010

CEN

EN ISO 10993-16:2009

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

This is the first publication

EN ISO 10993-16:1997

Note 2.1

21.3.2010

CEN

EN ISO 10993-17:2009

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

This is the first publication

EN ISO 10993-17:2002

Note 2.1

21.3.2010

CEN

EN ISO 10993-18:2009

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

This is the first publication

EN ISO 10993-18:2005

Note 2.1

21.3.2010

CEN

EN ISO 11135-1:2007

Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007)

9.8.2007

EN 550:1994

Note 2.1

31.5.2010

CEN

EN ISO 11137-1:2006

Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation 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

Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01)

9.8.2007

EN ISO 11137-2:2007/AC:2009

This is the first publication

CEN

EN ISO 11138-2:2009

Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006)

This is the first publication

EN ISO 11138-2:2006

Note 2.1

21.3.2010

CEN

EN ISO 11138-3:2009

Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006)

This is the first publication

EN ISO 11138-3:2006

Note 2.1

21.3.2010

CEN

EN ISO 11140-1:2009

Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)

This is the first publication

EN ISO 11140-1:2005

Note 2.1

21.3.2010

CEN

EN ISO 11140-3:2009

Sterilisation of healthcare 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)

This is the first publication

EN ISO 11140-3:2007

Note 2.1

21.3.2010

CEN

EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

This is the first publication

EN ISO 11197:2004

Note 2.1

21.3.2010

CEN

EN ISO 11607-1:2009

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

This is the first publication

EN ISO 11607-1:2006

Note 2.1

21.3.2010

CEN

EN ISO 11607-2:2006

Packaging for terminally sterilised 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

Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms 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

This is the first publication

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)

This is the first publication

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)

This is the first publication

EN ISO 11810-2:2007

Note 2.1

21.3.2010

CEN

EN ISO 11979-8:2009

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

This is the first publication

EN ISO 11979-8:2006

Note 2.1

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

This is the first publication

EN 12006-2:1998

Note 2.1

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

This is the first publication

EN 12006-3:1998

Note 2.1

21.3.2010

CEN

EN 12182:1999

Technical aids for disabled persons — General requirements and test methods

14.10.2000

CEN

EN 12342:1998

Breathing tubes intended for use with anaesthetic apparatus and ventilators

26.6.1999

CEN

EN 12470-1:2000 + A1:2009

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

This is the first publication

EN 12470-1:2000

Note 2.1

21.3.2010

CEN

EN 12470-2:2000 + A1:2009

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

This is the first publication

EN 12470-2:2000

Note 2.1

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

This is the first publication

EN 12470-3:2000

Note 2.1

21.3.2010

CEN

EN 12470-4:2000 + A1:2009

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

This is the first publication

EN 12470-4:2000

Note 2.1

21.3.2010

CEN

EN 12470-5:2003

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

7.11.2003

CEN

EN ISO 12870:2009

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

This is the first publication

EN ISO 12870:2004

Note 2.1

21.3.2010

CEN

EN 13060:2004 + A1:2009

Small steam sterilisers

This is the first publication

EN 13060:2004

Note 2.1

21.3.2010

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:2007

9.8.2007

CEN

EN 13544-1:2007

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

9.8.2007

EN 13544-1:2001

Note 2.1

Date expired

(31.10.2007)

CEN

EN 13544-2:2002

Respiratory therapy equipment — Part 2: Tubing and connectors

21.12.2002

CEN

EN 13544-3:2001

Respiratory therapy equipment — Part 3: Air entrainment devices

30.9.2005

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

This is the first publication

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

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

19.2.2009

CEN

EN 13795-2:2004

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

19.2.2009

CEN

EN 13795-3:2006

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

19.2.2009

CEN

EN 13824:2004

Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements

30.9.2005

CEN

EN 13867:2002 + A1:2009

Concentrates for haemodialysis and related therapies

This is the first publication

EN 13867:2002

Note 2.1

21.3.2010

CEN

EN 13976-1:2003

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

30.9.2005

CEN

EN 13976-2:2003

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

30.9.2005

EN 13976-2:2003/AC:2004

This is the first publication

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 ISO 14155-1:2003

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

11.11.2003

EN 540:1993

Note 2.1

Date expired

(31.8.2003)

CEN

EN ISO 14155-2:2003

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

11.11.2003

CEN

EN ISO 14160:1998

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

27.8.1998

CEN

EN 14180:2003 + A1:2009

Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — Requirements and testing

This is the first publication

EN 14180:2003

Note 2.1

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)

This is the first publication

EN ISO 14408:2005

Note 2.1

21.3.2010

CEN

EN ISO 14534:2009

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

This is the first publication

EN ISO 14534:2002

Note 2.1

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 14602:2009

Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:1998)

This is the first publication

EN ISO 14602:1998

Note 2.1

21.3.2010

CEN

EN ISO 14607:2009

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

This is the first publication

EN ISO 14607:2007

Note 2.1

21.3.2010

CEN

EN ISO 14630:2009

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

This is the first publication

EN ISO 14630:2008

Note 2.1

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)

This is the first publication

EN ISO 14889:2003

Note 2.1

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 14937:2000

Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000)

31.7.2002

EN ISO 14937:2000/AC:2005

This is the first publication

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

9.8.2007

EN ISO 14971:2000

Note 2.1

31.3.2010

CEN

EN ISO 15001:2004

Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003)

30.9.2005

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

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)

This is the first publication

EN ISO 15004-1:2006

Note 2.1

21.3.2010

CEN

EN ISO 15225:2000

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

31.7.2002

EN ISO 15225:2000/A1:2004

30.9.2005

Note 3

Date expired

(31.8.2004)

EN ISO 15225:2000/A2:2005

This is the first publication

Note 3

Date expired

(31.1.2006)

CEN

EN 15424:2007

Sterilisation of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilisation process for medical devices

9.8.2007

CEN

EN 15546-1:2008

Small bore connectors for liquids and gases in healthcare applications — Part 1 — General Requirements

23.7.2008

CEN

EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)

30.9.2005

CEN

EN ISO 15883-1:2009

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

This is the first publication

EN ISO 15883-1:2006

Note 2.1

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)

This is the first publication

EN ISO 15883-2:2006

Note 2.1

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)

This is the first publication

EN ISO 15883-3:2006

Note 2.1

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)

This is the first publication

EN ISO 15883-4:2008

Note 2.1

21.3.2010

CEN

EN ISO 16061:2008

Instrumentation for use in association with non-active surgical implants — General requirements (ISO 16061:2008)

19.2.2009

EN 12011:1998

Note 2.1

Date expired

(30.6.2009)

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)

This is the first publication

EN ISO 17510-1:2007

Note 2.1

21.3.2010

CEN

EN ISO 17510-2:2009

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

This is the first publication

EN ISO 17510-2:2007

Note 2.1

21.3.2010

CEN

EN ISO 17664:2004

Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of re-sterilisable medical devices (ISO 17664:2004)

30.9.2005

CEN

EN ISO 17665-1:2006

Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation 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)

This is the first publication

EN ISO 18777:2005

Note 2.1

21.3.2010

CEN

EN ISO 18778:2009

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

This is the first publication

EN ISO 18778:2005

Note 2.1

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

This is the first publication

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)

This is the first publication

EN ISO 21534:2007

Note 2.1

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)

This is the first publication

EN ISO 21535:2007

Note 2.1

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)

This is the first publication

EN ISO 21536:2007

Note 2.1

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)

This is the first publication

EN ISO 21647:2004

Note 2.1

21.3.2010

CEN

EN ISO 21649:2006

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

7.9.2006

CEN

EN ISO 21969:2006

High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)

7.9.2006

EN 13221:2000

Note 2.1

Date expired

(31.12.2007)

CEN

EN ISO 22442-1:2007

Medical devices utilising 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 utilising 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 utilising 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)

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

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)

This is the first publication

EN ISO 23328-2:2008

Note 2.1

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)

This is the first publication

EN ISO 23747:2007

Note 2.1

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)

This is the first publication

EN ISO 25539-1:2008

Note 2.1

21.3.2010

CEN

EN ISO 25539-2:2009

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

This is the first publication

EN ISO 25539-2:2008

Note 2.1

21.3.2010

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

This is the first publication

Cenelec

EN 60118-13:2005

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

IEC 60118-13:2004

19.1.2006

EN 60118-13:1997

Note 2.1

Date expired

(1.2.2008)

Cenelec

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

IEC 60522:1999

14.11.2001

Cenelec

EN 60580:2000

Medical electrical equipment — Dose area product meters

IEC 60580:2000

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

EN 60601-1:1990/A2:1995

IEC 60601-1:1988/A2:1995

18.11.1995

Note 3

Cenelec

EN 60601-1:2006

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

IEC 60601-1:2005

27.11.2008

EN 60601-1:1990

and its amendments

Note 2.1

Cenelec

EN 60601-1-1:2001

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

IEC 60601-1-1:2000

14.11.2001

EN 60601-1-1:1993

- A1:1996

Note 2.1

Date expired

(1.12.2003)

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

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)

27.11.2008

EN 60601-1-2:2001

and its amendment

Note 2.1

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

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

27.11.2008

EN 60601-1-3:1994

Note 2.1

Date expired

(1.7.1995)

Cenelec

EN 60601-1-4:1996

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

IEC 60601-1-4:1996

8.11.1997

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

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

8.11.1997

Note 3

Date expired

(1.12.2002)

Cenelec

EN 60601-1-6:2004

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

IEC 60601-1-6:2004

2.7.2006

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

27.11.2008

EN 60601-1-6:2004

Note 2.1

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

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

27.11.2008

EN 60601-1-8:2004

and its amendment

Note 2.1

Cenelec

EN 60601-1-10:2008

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

IEC 60601-1-10:2007

27.11.2008

Cenelec

EN 60601-2-1:1998

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

IEC 60601-2-1:1998

14.11.2001

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

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

13.12.2002

Note 3

Date expired

(1.6.2005)

Cenelec

EN 60601-2-2:2000

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

IEC 60601-2-2:1998

13.12.2002

EN 60601-2-2:1993

Note 2.1

Date expired

(1.8.2003)

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

22.12.2007

EN 60601-2-2:2000

Note 2.1

Date expired

(1.10.2009)

Cenelec

EN 60601-2-3:1993

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

IEC 60601-2-3:1991

18.11.1995

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

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

18.11.1995

Note 3

Date expired

(1.7.2001)

Cenelec

EN 60601-2-4:2003

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

IEC 60601-2-4:2002

15.10.2003

Cenelec

EN 60601-2-5:2000

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

IEC 60601-2-5:2000

13.12.2002

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

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

14.11.2001

Note 3

Date expired

(1.6.1998)

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

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

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

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

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

9.10.1999

Cenelec

EN 60601-2-17:2004

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

IEC 60601-2-17:2004

8.11.2005

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

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

9.10.1999

Note 3

Date expired

(13.6.1998)

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

9.10.1999

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

23.8.2006

Note 3

Date expired

(13.6.1998)

Cenelec

EN 60601-2-22:1996

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

IEC 60601-2-22:1995

17.5.1997

Cenelec

EN 60601-2-23:2000

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

IEC 60601-2-23:1999

14.11.2001

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

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

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

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

26.7.2006

EN 60601-2-27:1994

Note 2.1

Date expired

(1.11.2008)

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

18.11.1995

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

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

15.7.2009

EN 60601-2-29:1999

Note 2.1

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

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

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

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

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

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

9.10.1999

Cenelec

EN 60601-2-36:1997

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

IEC 60601-2-36:1997

9.10.1999

Cenelec

EN 60601-2-37:2001

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

IEC 60601-2-37:2001

13.12.2002

EN 60601-2-37:2001/A1:2005

IEC 60601-2-37:2001/A1:2004

8.11.2005

Note 3

Date expired

(1.1.2008)

EN 60601-2-37:2001/A2:2005

IEC 60601-2-37:2001/A2:2005

26.7.2006

Note 3

Date expired

(1.12.2008)

Cenelec

EN 60601-2-37:2008

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

IEC 60601-2-37:2007

27.11.2008

EN 60601-2-37:2001

and its amendments

Note 2.1

1.10.2010

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

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

14.11.2001

Cenelec

EN 60601-2-39:2008

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

IEC 60601-2-39:2007

27.11.2008

EN 60601-2-39:1999

Note 2.1

1.3.2011

Cenelec

EN 60601-2-40:1998

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

IEC 60601-2-40:1998

9.10.1999

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

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

13.12.2002

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

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

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

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

13.12.2002

Cenelec

EN 60601-2-49:2001

Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

IEC 60601-2-49:2001

13.12.2002

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

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

24.6.2004

Cenelec

EN 60627:2001

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

IEC 60627:2001

13.12.2002

Cenelec

EN 60645-1:2001

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

IEC 60645-1:2001

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

17.5.1997

Cenelec

EN 60645-3:1995

Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes

IEC 60645-3:1994

23.8.1996

Cenelec

EN 60645-3:2007

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

IEC 60645-3:2007

27.11.2008

EN 60645-3:1995

Note 2.1

1.6.2010

Cenelec

EN 60645-4:1995

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

IEC 60645-4:1994

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

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

Cenelec

EN 62083:2001

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

IEC 62083:2000

13.12.2002

Cenelec

EN 62220-1:2004

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency

IEC 62220-1:2003

24.6.2004

Cenelec

EN 62220-1-2:2007

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-2: Determination of the detective quantum efficiency — Detectors used in mammography

IEC 62220-1-2:2007

27.11.2008

Cenelec

EN 62220-1-3:2008

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1-3: Determination of the detective quantum efficiency — Detectors used in dynamic imaging

IEC 62220-1-3:2008

15.7.2009

Cenelec

EN 62304:2006

Medical device software — Software lifecycle processes

IEC 62304:2006

27.11.2008

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 of the 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 of the Council (2) amended by the Directive 98/48/EC (3).

| — | 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/newapproach/standardization/harmstds/ |
| --- | --- |

—

More information about harmonised standards on the Internet at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

---

(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu).

Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, 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).

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

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

---

| 2.12.2009 | EN | Official Journal of the European Union | C 293/69 |
| --- | --- | --- | --- |

2.12.2009

EN

Official Journal of the European Union

C 293/69

---

Commission communication in the framework of the implementation of 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)

2009/C 293/04

| European Standards Organisation (1) | Reference and title of the harmonised standard
  (and reference document) | First publication in the Official Journal | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| CEN | EN 375:2001
  Information supplied by the manufacturer with in-vitro diagnostic reagents for professional use | 31.7.2002 | | |
| CEN | EN 376:2002
  Information supplied by the manufacturer with in-vitro diagnostic reagents for self-testing | 31.7.2002 | | |
| CEN | EN 556-1:2001
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised 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
  Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | 9.8.2007 | | |
| CEN | EN 591:2001
  Instructions for use for in-vitro diagnostic instruments for professional use | 31.7.2002 | | |
| CEN | EN 592:2002
  Instructions for use for in-vitro diagnostic instruments for self-testing | 31.7.2002 | | |
| CEN | EN 980:2008
  Symbols for use in the labelling of medical devices | 23.7.2008 | EN 980:2003
  Note 2.1 | 31.5.2010 |
| 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) | This is the first publication | | |
| 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) | This is the first publication | | |
| CEN | EN 12286:1998
  In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures | 10.8.1999 | | |
| EN 12286:1998/A1:2000 | 14.11.2001 | Note 3 | Date expired
  (24.11.2000) |
| CEN | EN 12287:1999
  In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials | 14.10.2000 | | |
| 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 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:2007 | 9.8.2007 |
| 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 | This is the first publication |
| 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 14937:2000
  Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) | 31.7.2002 | | |
| EN ISO 14937:2000/AC:2005 | This is the first publication |
| CEN | EN ISO 14971:2007
  Medical devices — Application of risk management to medical devices (ISO 14971:2007) | 9.8.2007 | EN ISO 14971:2000
  Note 2.1 | 31.3.2010 |
| 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 | This is the first publication |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | 31.7.2002 | | |
| EN ISO 15225:2000/A1:2004 | This is the first publication | Note 3 | Date expired
  (31.8.2004) |
| EN ISO 15225:2000/A2:2005 | This is the first publication | Note 3 | Date expired
  (31.1.2006) |
| 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 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 lifecycle processes
  IEC 62304:2006 | 27.11.2008 | | |
| Cenelec | EN 62366:2008
  Medical devices — Application of usability engineering to medical devices
  IEC 62366:2007 | 27.11.2008 | | |

European Standards Organisation (1)

Reference and title of the harmonised standard

(and reference document)

First publication in the Official Journal

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 375:2001

Information supplied by the manufacturer with in-vitro diagnostic reagents for professional use

31.7.2002

CEN

EN 376:2002

Information supplied by the manufacturer with in-vitro diagnostic reagents for self-testing

31.7.2002

CEN

EN 556-1:2001

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

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

9.8.2007

CEN

EN 591:2001

Instructions for use for in-vitro diagnostic instruments for professional use

31.7.2002

CEN

EN 592:2002

Instructions for use for in-vitro diagnostic instruments for self-testing

31.7.2002

CEN

EN 980:2008

Symbols for use in the labelling of medical devices

23.7.2008

EN 980:2003

Note 2.1

31.5.2010

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)

This is the first publication

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)

This is the first publication

CEN

EN 12286:1998

In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures

10.8.1999

EN 12286:1998/A1:2000

14.11.2001

Note 3

Date expired

(24.11.2000)

CEN

EN 12287:1999

In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

14.10.2000

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 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:2007

9.8.2007

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

This is the first publication

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 14937:2000

Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000)

31.7.2002

EN ISO 14937:2000/AC:2005

This is the first publication

CEN

EN ISO 14971:2007

Medical devices — Application of risk management to medical devices (ISO 14971:2007)

9.8.2007

EN ISO 14971:2000

Note 2.1

31.3.2010

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

This is the first publication

CEN

EN ISO 15225:2000

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

31.7.2002

EN ISO 15225:2000/A1:2004

This is the first publication

Note 3

Date expired

(31.8.2004)

EN ISO 15225:2000/A2:2005

This is the first publication

Note 3

Date expired

(31.1.2006)

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 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 lifecycle processes

IEC 62304:2006

27.11.2008

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 of the 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 of the Council (2) amended by the Directive 98/48/EC (3).

| — | 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/newapproach/standardization/harmstds/ |
| --- | --- |

—

More information about harmonised standards on the Internet at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

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(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu).

Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, 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).

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

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

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