# Official Journal C 163/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.163.eng |
| --- | --- |
| Official Journal
  of the European Union | C 163 |
| | |
| English edition | Information and Notices | Volume 5215 July 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.163.eng

Official Journal

of the European Union

C 163

English edition

Information and Notices

Volume 5215 July 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 163/01 | 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
  ) | 1 |
| 2009/C 163/02 | 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
  ) | 6 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 163/01

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

1

2009/C 163/02

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

6

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

---

(1)   Text with EEA relevance

1

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 15.7.2009 | EN | Official Journal of the European Union | C 163/1 |
| --- | --- | --- | --- |

15.7.2009

EN

Official Journal of the European Union

C 163/1

---

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 163/01

| European Standardisation 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 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | 24.6.2005 | | |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | 23.1.2003 | EN 30993-4:1993
  Note 2.1 | Date expired
  (30.4.2003) |
| EN ISO 10993-4:2002/A1:2006 | 15.11.2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in-vitro cytotoxicity (ISO 10993-5:1999) | 9.10.1999 | EN 30993-5:1994
  Note 2.1 | Date expired
  (30.11.1999) |
| CEN | EN ISO 10993-6:2007
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | 9.8.2007 | EN 30993-6:1994
  Note 2.1 | Date expired
  (31.10.2007) |
| CEN | EN ISO 10993-9:1999
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | 10.8.1999 | | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | 23.1.2003 | EN ISO 10993-10:1995
  Note 2.1 | Date expired
  (31.3.2003) |
| EN ISO 10993-10:2002/A1:2006 | 15.11.2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-11:2006
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | 15.11.2006 | EN ISO 10993-11:1995
  Note 2.1 | Date expired
  (28.2.2007) |
| CEN | EN ISO 10993-12:2007
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | 27.2.2008 | EN ISO 10993-12:2004
  Note 2.1 | Date expired
  (31.5.2008) |
| CEN | EN ISO 10993-13:1998
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | 10.8.1999 | | |
| CEN | EN ISO 10993-16:1997
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | 9.5.1998 | | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | 11.11.2003 | | |
| CEN | EN ISO 10993-18:2005
  Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) | 2.6.2006 | | |
| 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 | | |
| CEN | EN ISO 11138-2:2006
  Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) | 15.11.2006 | | |
| CEN | EN ISO 11138-3:2006
  Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) | 15.11.2006 | | |
| CEN | EN ISO 11140-1:2005
  Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | 15.11.2006 | | |
| CEN | EN ISO 11607-1:2006
  Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | 7.9.2006 | EN 868-1:1997
  Note 2.1 | Date expired
  (30.4.2007) |
| CEN | EN ISO 11737-1:2006
  Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | 7.9.2006 | EN 1174-2:1996
  EN 1174-1:1996
  EN 1174-3:1996
  Note 2.1 | Date expired
  (31.10.2006) |
| 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 | 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 | | |
| 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 | 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 amendment | 1.5.2010 |
| Cenelec | EN 62304:2006
  Medical device software — Software lifecycle processes IEC 62304:2006 | 27.11.2008 | | |

European Standardisation 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 10993-1:2003

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

24.6.2005

CEN

EN ISO 10993-4:2002

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

23.1.2003

EN 30993-4:1993

Note 2.1

Date expired

(30.4.2003)

EN ISO 10993-4:2002/A1:2006

15.11.2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-5:1999

Biological evaluation of medical devices — Part 5: Tests for in-vitro cytotoxicity (ISO 10993-5:1999)

9.10.1999

EN 30993-5:1994

Note 2.1

Date expired

(30.11.1999)

CEN

EN ISO 10993-6:2007

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

9.8.2007

EN 30993-6:1994

Note 2.1

Date expired

(31.10.2007)

CEN

EN ISO 10993-9:1999

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

10.8.1999

CEN

EN ISO 10993-10:2002

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

23.1.2003

EN ISO 10993-10:1995

Note 2.1

Date expired

(31.3.2003)

EN ISO 10993-10:2002/A1:2006

15.11.2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-11:2006

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

15.11.2006

EN ISO 10993-11:1995

Note 2.1

Date expired

(28.2.2007)

CEN

EN ISO 10993-12:2007

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

27.2.2008

EN ISO 10993-12:2004

Note 2.1

Date expired

(31.5.2008)

CEN

EN ISO 10993-13:1998

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

10.8.1999

CEN

EN ISO 10993-16:1997

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

9.5.1998

CEN

EN ISO 10993-17:2002

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

11.11.2003

CEN

EN ISO 10993-18:2005

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

2.6.2006

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

CEN

EN ISO 11138-2:2006

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

15.11.2006

CEN

EN ISO 11138-3:2006

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

15.11.2006

CEN

EN ISO 11140-1:2005

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

15.11.2006

CEN

EN ISO 11607-1:2006

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

7.9.2006

EN 868-1:1997

Note 2.1

Date expired

(30.4.2007)

CEN

EN ISO 11737-1:2006

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

7.9.2006

EN 1174-2:1996

EN 1174-1:1996

EN 1174-3:1996

Note 2.1

Date expired

(31.10.2006)

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

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

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

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 amendment

1.5.2010

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 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.

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 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 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 2519 68 71, fax: +32 25196919 (http://www.cenelec.org).

ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, France, tel. +33 492944200, fax: +33 493654716 (http://www.etsi.org).

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

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

---

| 15.7.2009 | EN | Official Journal of the European Union | C 163/6 |
| --- | --- | --- | --- |

15.7.2009

EN

Official Journal of the European Union

C 163/6

---

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 163/02

| European Standardisation 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+A1:2008
  Sterilisation — Steam sterilisers — Large sterilisers | 19.2.2009 | EN 285:2006
  Note 2.1 | Date expired
  (30.11.2008) |
| 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
  Lung ventilators — Part 1: Particular requirements for critical care ventilators | 8.11.1997 | | |
| EN 794-1:1997/A1:2000 | 31.7.2002 | Note 3 | Date expired
  (31.5.2001) |
| 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 | | |
| 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
  Sterilisers for medical purposes — Ethylene oxide sterilisers — Requirements and test methods | 9.5.1998 | | |
| 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) |
| 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 5360:2007
  Anaesthetic vaporisers — Agent-specific filling systems (ISO 5360:2006) | 27.2.2008 | EN 1280-1:1997
  Note 2.1 | Date expired
  (30.6.2008) |
| CEN | EN ISO 5366-1:2004
  Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) | 30.9.2005 | EN 1282-1:1996
  Note 2.1 | Date expired
  (31.1.2005) |
| CEN | EN ISO 5840:2005
  Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005) | 2.6.2006 | EN 12006-1:1999
  Note 2.1 | Date expired
  (30.6.2006) |
| CEN | EN ISO 7197:2006
  Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006) | 7.9.2006 | | |
| CEN | EN ISO 7376:2003
  Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003) | 30.9.2005 | EN 1819:1997
  Note 2.1 | Date expired
  (30.6.2004) |
| 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 7439:2002
  Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002) | 30.9.2005 | | |
| 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 8185:2007
  Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems (ISO 8185:2007) | 9.11.2007 | EN ISO 8185:1997
  Note 2.1 | Date expired
  (31.1.2008) |
| CEN | EN ISO 8359:1996
  Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) | 8.11.1997 | | |
| 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 8835-2:2007
  Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) | 9.11.2007 | EN 740:1998
  Note 2.1 | Date expired
  (31.5.2009) |
| CEN | EN ISO 8835-3:2007
  Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) | 9.11.2007 | EN 740:1998
  Note 2.1 | Date expired
  (31.5.2009) |
| CEN | EN ISO 8835-4:2004
  Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) | 30.9.2005 | | |
| EN ISO 8835-4:2004/AC:2006 | 2.6.2006 | | |
| CEN | EN ISO 8835-5:2004
  Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004) | 30.9.2005 | | |
| EN ISO 8835-5:2004/AC:2006 | 15.11.2006 | | |
| 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 9360-1:2000
  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) | 30.9.2005 | | |
| CEN | EN ISO 9360-2:2002
  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) | 27.3.2003 | | |
| CEN | EN ISO 9713:2004
  Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) | 30.9.2005 | | |
| CEN | EN ISO 9919:2005
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) | 30.9.2005 | EN 865:1997
  Note 2.1 | Date expired
  (30.9.2005) |
| CEN | EN ISO 10079-1:1999
  Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) | 26.6.2009 | EN ISO 10079-1:1996
  Note 2.1 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-2:1999
  Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) | 26.6.1999 | EN ISO 10079-2:1996
  Note 2.1 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-3:1999
  Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999) | 26.6.1999 | EN ISO 10079-3:1996
  Note 2.1 | Date expired
  (29.2.2000) |
| 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 10555-1:1996
  Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995) | 15.5.1997 | | |
| EN ISO 10555-1:1996/A1:1999 | 26.6.1999 | Note 3 | Date expired
  (31.1.2000) |
| EN ISO 10555-1:1996/A2:2004 | 30.9.2005 | Note 3 | Date expired
  (30.11.2004) |
| CEN | EN ISO 10651-2:2004
  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) | 30.9.2005 | EN 794-2:1997
  Note 2.1 | Date expired
  (31.1.2005) |
| CEN | EN ISO 10651-4:2002
  Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | 13.12.2002 | | |
| CEN | EN ISO 10651-6:2004
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) | 30.9.2005 | | |
| CEN | EN ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | 30.9.2005 | | |
| CEN | EN ISO 10993-3:2003
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) | 30.9.2005 | EN 30993-3:1993
  Note 2.1 | Date expired
  (30.4.2004) |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | 23.1.2002 | EN 30993-4:1993
  Note 2.1 | Date expired
  (30.4.2003) |
| EN ISO 10993-4:2002/A1:2006 | 15.11.2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | 9.10.1999 | EN 30993-5:1994
  Note 2.1 | Date expired
  (30.11.1999) |
| CEN | EN ISO 10993-6:2007
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) | 9.8.2007 | EN 30993-6:1994
  Note 2.1 | Date expired
  (31.10.2007) |
| 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 10993-9:1999
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | 10.8.1999 | | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | 23.1.2002 | EN ISO 10993-10:1995
  Note 2.1 | Date expired
  (31.3.2003) |
| EN ISO 10993-10:2002/A1:2006 | 15.11.2006 | Note 3 | Date expired
  (31.1.2007) |
| CEN | EN ISO 10993-11:2006
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) | 15.11.2006 | EN ISO 10993-11:1995
  Note 2.1 | Date expired
  (28.2.2007) |
| CEN | EN ISO 10993-12:2007
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) | 27.2.2008 | EN ISO 10993-12:2004
  Note 2.1 | Date expired
  (31.5.2008) |
| CEN | EN ISO 10993-13:1998
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | 10.8.1999 | | |
| CEN | EN ISO 10993-14:2001
  Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) | 31.7.2002 | | |
| CEN | EN ISO 10993-15:2000
  Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) | 14.11.2001 | | |
| CEN | EN ISO 10993-16:1997
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | 9.5.1998 | | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | 11.11.2003 | | |
| CEN | EN ISO 10993-18:2005
  Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) | 2.6.2006 | | |
| CEN | EN ISO 11135-1:2007
  Sterilisation of health care 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 health care 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 health care products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01) | 9.8.2007 | | |
| CEN | EN ISO 11138-2:2006
  Sterilisation of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) | 15.11.2006 | | |
| CEN | EN ISO 11138-3:2006
  Sterilisation of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) | 15.11.2006 | | |
| CEN | EN ISO 11140-1:2005
  Sterilisation of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | 2.6.2006 | EN 867-2:1997
  Note 2.1 | Date expired
  (31.1.2006) |
| CEN | EN ISO 11140-3:2007
  Sterilisation of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007) | 9.8.2007 | EN 867-3:1997
  Note 2.1 | Date expired
  (30.9.2007) |
| CEN | EN ISO 11197:2004
  Medical supply units (ISO 11197:2004) | 30.9.2005 | EN 793:1997
  Note 2.1 | Date expired
  (30.6.2005) |
| CEN | EN ISO 11607-1:2006
  Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) | 7.9.2006 | EN 868-1:1997
  Note 2.1 | Date expired
  (30.4.2007) |
| 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 microorganisms on products (ISO 11737-1:2006) | 7.9.2006 | EN 1174-2:1996
  EN 1174-1:1996
  EN 1174-3:1996
  Note 2.1 | Date expired
  (31.10.2006) |
| CEN | EN ISO 11810-2:2007
  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) | 9.8.2007 | | |
| CEN | EN ISO 11979-8:2006
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:2006) | 15.11.2006 | EN 13503-8:2000
  Note 2.1 | Date expired
  (31.1.2007) |
| 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
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits | 27.8.1998 | | |
| CEN | EN 12006-3:1998
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices | 10.8.1999 | | |
| 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
  Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device | 14.10.2000 | | |
| CEN | EN 12470-2:2000
  Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers | 14.11.2001 | | |
| CEN | EN 12470-3:2000
  Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | 14.10.2000 | | |
| CEN | EN 12470-4:2000
  Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement | 14.11.2001 | | |
| CEN | EN 12470-5:2003
  Clinical thermometers — Part 5: Performance of infrared ear thermometers (with maximum device) | 7.11.2003 | | |
| CEN | EN ISO 12870:2004
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) | 30.9.2005 | EN ISO 12870:1997
  Note 2.1 | Date expired
  (28.2.2005) |
| EN ISO 12870:2004/AC:2005 | 30.9.2005 | | |
| CEN | EN 13014:2000
  Connections for gas sampling tubes to anaesthetic and respiratory equipment | 14.11.2001 | | |
| CEN | EN 13060:2004
  Small steam sterilizers | 30.9.2005 | | |
| 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 | 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 | | |
| 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
  Concentrates for haemodialysis and related therapies | 21.12.2002 | | |
| 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 | | |
| 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
  Sterilisers for medical purposes — Low temperature steam and formaldehyde sterilisers — Requirements and testing | 7.11.2003 | | |
| 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 14408:2005
  Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) | 30.9.2005 | | |
| CEN | EN ISO 14534:2002
  Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002) | 13.12.2002 | EN ISO 14534:1997
  Note 2.1 | Date expired
  (31.12.2002) |
| 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 14602:1998
  Non-active surgical implants — Implants for Osteosynthesis — Particular requirements (ISO 14602:1998) | 27.8.1998 | | |
| CEN | EN ISO 14607:2007
  Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007) | 9.8.2007 | | |
| CEN | EN ISO 14630:2008
  Non-active surgical implants — General requirements (ISO 14630:2008) | 23.7.2008 | EN ISO 14630:2005
  Note 2.1 | Date expired
  (31.7.2008) |
| CEN | EN 14683:2005
  Surgical masks — Requirements and test methods | 2.6.2006 | | |
| CEN | EN ISO 14889:2003
  Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) | 7.11.2003 | EN ISO 14889:1997
  Note 2.1 | Date expired
  (30.11.2003) |
| 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 health care 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 | | |
| 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 15004-1:2006
  Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) | 15.11.2006 | EN ISO 15004:1997
  Note 2.1 | Date expired
  (31.12.2006) |
| 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) |
| 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 15883-1:2006
  Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) | 7.9.2006 | | |
| CEN | EN ISO 15883-2:2006
  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) | 7.9.2006 | | |
| CEN | EN ISO 15883-3:2006
  Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) | 7.9.2006 | | |
| CEN | EN ISO 15883-4:2008
  Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) | 23.7.2008 | | |
| 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 17510-1:2007
  Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) | 27.2.2008 | EN ISO 17510-1:2002
  Note 2.1 | Date expired
  (30.4.2008) |
| CEN | EN ISO 17510-2:2007
  Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2007) | 27.2.2008 | EN ISO 17510-2:2003
  Note 2.1 | Date expired
  (30.4.2008) |
| CEN | EN ISO 17664:2004
  Sterilisation of medical devices — Information to be provided by the manufacturer for the processing of resterilisable medical devices (ISO 17664:2004) | 30.9.2005 | | |
| CEN | EN ISO 17665-1:2006
  Sterilisation of health care 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 | 31.8.2009 |
| CEN | EN ISO 18777:2005
  Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) | 30.9.2005 | | |
| CEN | EN ISO 18778:2005
  Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) | 30.9.2005 | | |
| 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) |
| CEN | EN ISO 21171:2006
  Medical gloves — Determination of removable surface powder (ISO 21171:2006) | 7.9.2006 | | |
| CEN | EN ISO 21534:2007
  Non-active surgical implants — Joint replacement implants — Particular requirements (ISO 21534:2007) | 9.11.2007 | EN 12010:1998
  Note 2.1 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21535:2007
  Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007) | 9.11.2007 | EN 12563:1998
  Note 2.1 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21536:2007
  Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007) | 9.11.2007 | EN 12564:1998
  Note 2.1 | Date expired
  (31.3.2008) |
| CEN | EN ISO 21647:2004
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) | 30.9.2005 | EN 12598:1999
  EN ISO 11196:1997
  EN 864:1996
  Note 2.1 | Date expired
  (31.5.2005) |
| EN ISO 21647:2004/AC:2006 | 2.6.2006 | | |
| 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 23328-2:2008
  Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects (ISO 23328-2:2002) | 19.2.2009 | EN 13328-2:2002
  Note 2.1 | Date expired
  (30.9.2008) |
| CEN | EN ISO 23747:2007
  Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) | 27.2.2008 | EN 13826:2003
  Note 2.1 | Date expired
  (31.1.2008) |
| CEN | EN ISO 25539-1:2008
  Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) | 19.2.2009 | EN 14299:2004
  Note 2.1 | 30.9.2011 |
| CEN | EN ISO 25539-2:2008
  Cardiovascular implants — Endovascular devices — Part 2: Vascular stents (ISO 25539-2:2008) | 19.2.2009 | EN 14299:2004
  Note 2.1 | 30.9.2011 |
| 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) |
| 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 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 | |
| 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 | Date expired
  (1.9.2007) |
| 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 | |
| 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 | Date expired
  (1.12.2006) |
| 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 | |
| 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 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999 | 14.11.2001 | | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 60580:2000
  Medical electrical equipment — Dose area product meters IEC 60580:2000 | 13.12.2002 | | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 60601-1:1990
  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 60601-2-27:2006
  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 | This is the first publication | 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 | |
| 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 | |
| EN 60601-2-33:2002/A2:2008 IEC 60601-2-33:2002/A2:2007 | 27.11.2008 | Note 3 | |
| 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 60601-1:2006
  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 amendment | Date expired
  (1.2.2003) |
| 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 | |
| EN 60601-2-37:2001/A2:2005 IEC 60601-2-37:2001/A2:2005 | 26.7.2006 | Note 3 | |
| 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 amendment | 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 | |
| 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 | |
| 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 60601-2-45:2001
  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 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 | |
| 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 | |
| EN 61217:1996/A2:2008 IEC 61217:1996/A2:2007 | 27.11.2008 | Note 3 | |
| 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 | This is the first publication | | |
| Cenelec | EN 62304:2006
  Medical device software — Software life-cycle 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 | | |
| 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 | Date expired
  (1.11.2004) |
| 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 | | |

European Standardisation 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+A1:2008

Sterilisation — Steam sterilisers — Large sterilisers

19.2.2009

EN 285:2006

Note 2.1

Date expired

(30.11.2008)

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

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

8.11.1997

EN 794-1:1997/A1:2000

31.7.2002

Note 3

Date expired

(31.5.2001)

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

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

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

9.5.1998

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)

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 5360:2007

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

27.2.2008

EN 1280-1:1997

Note 2.1

Date expired

(30.6.2008)

CEN

EN ISO 5366-1:2004

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

30.9.2005

EN 1282-1:1996

Note 2.1

Date expired

(31.1.2005)

CEN

EN ISO 5840:2005

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

2.6.2006

EN 12006-1:1999

Note 2.1

Date expired

(30.6.2006)

CEN

EN ISO 7197:2006

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

7.9.2006

CEN

EN ISO 7376:2003

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

30.9.2005

EN 1819:1997

Note 2.1

Date expired

(30.6.2004)

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 7439:2002

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

30.9.2005

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 8185:2007

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

9.11.2007

EN ISO 8185:1997

Note 2.1

Date expired

(31.1.2008)

CEN

EN ISO 8359:1996

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

8.11.1997

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 8835-2:2007

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

9.11.2007

EN 740:1998

Note 2.1

Date expired

(31.5.2009)

CEN

EN ISO 8835-3:2007

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

9.11.2007

EN 740:1998

Note 2.1

Date expired

(31.5.2009)

CEN

EN ISO 8835-4:2004

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

30.9.2005

EN ISO 8835-4:2004/AC:2006

2.6.2006

CEN

EN ISO 8835-5:2004

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

30.9.2005

EN ISO 8835-5:2004/AC:2006

15.11.2006

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 9360-1:2000

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)

30.9.2005

CEN

EN ISO 9360-2:2002

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)

27.3.2003

CEN

EN ISO 9713:2004

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

30.9.2005

CEN

EN ISO 9919:2005

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

30.9.2005

EN 865:1997

Note 2.1

Date expired

(30.9.2005)

CEN

EN ISO 10079-1:1999

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

26.6.2009

EN ISO 10079-1:1996

Note 2.1

Date expired

(29.2.2000)

CEN

EN ISO 10079-2:1999

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

26.6.1999

EN ISO 10079-2:1996

Note 2.1

Date expired

(29.2.2000)

CEN

EN ISO 10079-3:1999

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

26.6.1999

EN ISO 10079-3:1996

Note 2.1

Date expired

(29.2.2000)

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 10555-1:1996

Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995)

15.5.1997

EN ISO 10555-1:1996/A1:1999

26.6.1999

Note 3

Date expired

(31.1.2000)

EN ISO 10555-1:1996/A2:2004

30.9.2005

Note 3

Date expired

(30.11.2004)

CEN

EN ISO 10651-2:2004

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)

30.9.2005

EN 794-2:1997

Note 2.1

Date expired

(31.1.2005)

CEN

EN ISO 10651-4:2002

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

13.12.2002

CEN

EN ISO 10651-6:2004

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

30.9.2005

CEN

EN ISO 10993-1:2003

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

30.9.2005

CEN

EN ISO 10993-3:2003

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

30.9.2005

EN 30993-3:1993

Note 2.1

Date expired

(30.4.2004)

CEN

EN ISO 10993-4:2002

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

23.1.2002

EN 30993-4:1993

Note 2.1

Date expired

(30.4.2003)

EN ISO 10993-4:2002/A1:2006

15.11.2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-5:1999

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

9.10.1999

EN 30993-5:1994

Note 2.1

Date expired

(30.11.1999)

CEN

EN ISO 10993-6:2007

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

9.8.2007

EN 30993-6:1994

Note 2.1

Date expired

(31.10.2007)

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 10993-9:1999

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

10.8.1999

CEN

EN ISO 10993-10:2002

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

23.1.2002

EN ISO 10993-10:1995

Note 2.1

Date expired

(31.3.2003)

EN ISO 10993-10:2002/A1:2006

15.11.2006

Note 3

Date expired

(31.1.2007)

CEN

EN ISO 10993-11:2006

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

15.11.2006

EN ISO 10993-11:1995

Note 2.1

Date expired

(28.2.2007)

CEN

EN ISO 10993-12:2007

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

27.2.2008

EN ISO 10993-12:2004

Note 2.1

Date expired

(31.5.2008)

CEN

EN ISO 10993-13:1998

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

10.8.1999

CEN

EN ISO 10993-14:2001

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

31.7.2002

CEN

EN ISO 10993-15:2000

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

14.11.2001

CEN

EN ISO 10993-16:1997

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

9.5.1998

CEN

EN ISO 10993-17:2002

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

11.11.2003

CEN

EN ISO 10993-18:2005

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

2.6.2006

CEN

EN ISO 11135-1:2007

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

9.8.2007

CEN

EN ISO 11138-2:2006

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

15.11.2006

CEN

EN ISO 11138-3:2006

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

15.11.2006

CEN

EN ISO 11140-1:2005

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

2.6.2006

EN 867-2:1997

Note 2.1

Date expired

(31.1.2006)

CEN

EN ISO 11140-3:2007

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

9.8.2007

EN 867-3:1997

Note 2.1

Date expired

(30.9.2007)

CEN

EN ISO 11197:2004

Medical supply units (ISO 11197:2004)

30.9.2005

EN 793:1997

Note 2.1

Date expired

(30.6.2005)

CEN

EN ISO 11607-1:2006

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

7.9.2006

EN 868-1:1997

Note 2.1

Date expired

(30.4.2007)

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 microorganisms on products (ISO 11737-1:2006)

7.9.2006

EN 1174-2:1996

EN 1174-1:1996

EN 1174-3:1996

Note 2.1

Date expired

(31.10.2006)

CEN

EN ISO 11810-2:2007

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)

9.8.2007

CEN

EN ISO 11979-8:2006

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

15.11.2006

EN 13503-8:2000

Note 2.1

Date expired

(31.1.2007)

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

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

27.8.1998

CEN

EN 12006-3:1998

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

10.8.1999

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

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

14.10.2000

CEN

EN 12470-2:2000

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

14.11.2001

CEN

EN 12470-3:2000

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

14.10.2000

CEN

EN 12470-4:2000

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

14.11.2001

CEN

EN 12470-5:2003

Clinical thermometers — Part 5: Performance of infrared ear thermometers (with maximum device)

7.11.2003

CEN

EN ISO 12870:2004

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

30.9.2005

EN ISO 12870:1997

Note 2.1

Date expired

(28.2.2005)

EN ISO 12870:2004/AC:2005

30.9.2005

CEN

EN 13014:2000

Connections for gas sampling tubes to anaesthetic and respiratory equipment

14.11.2001

CEN

EN 13060:2004

Small steam sterilizers

30.9.2005

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

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

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

Concentrates for haemodialysis and related therapies

21.12.2002

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

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

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

7.11.2003

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 14408:2005

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

30.9.2005

CEN

EN ISO 14534:2002

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

13.12.2002

EN ISO 14534:1997

Note 2.1

Date expired

(31.12.2002)

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 14602:1998

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

27.8.1998

CEN

EN ISO 14607:2007

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

9.8.2007

CEN

EN ISO 14630:2008

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

23.7.2008

EN ISO 14630:2005

Note 2.1

Date expired

(31.7.2008)

CEN

EN 14683:2005

Surgical masks — Requirements and test methods

2.6.2006

CEN

EN ISO 14889:2003

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

7.11.2003

EN ISO 14889:1997

Note 2.1

Date expired

(30.11.2003)

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 health care 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

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 15004-1:2006

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

15.11.2006

EN ISO 15004:1997

Note 2.1

Date expired

(31.12.2006)

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)

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 15883-1:2006

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

7.9.2006

CEN

EN ISO 15883-2:2006

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)

7.9.2006

CEN

EN ISO 15883-3:2006

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

7.9.2006

CEN

EN ISO 15883-4:2008

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

23.7.2008

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 17510-1:2007

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

27.2.2008

EN ISO 17510-1:2002

Note 2.1

Date expired

(30.4.2008)

CEN

EN ISO 17510-2:2007

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

27.2.2008

EN ISO 17510-2:2003

Note 2.1

Date expired

(30.4.2008)

CEN

EN ISO 17664:2004

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

30.9.2005

CEN

EN ISO 17665-1:2006

Sterilisation of health care 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

31.8.2009

CEN

EN ISO 18777:2005

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

30.9.2005

CEN

EN ISO 18778:2005

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

30.9.2005

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)

CEN

EN ISO 21171:2006

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

7.9.2006

CEN

EN ISO 21534:2007

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

9.11.2007

EN 12010:1998

Note 2.1

Date expired

(31.3.2008)

CEN

EN ISO 21535:2007

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

9.11.2007

EN 12563:1998

Note 2.1

Date expired

(31.3.2008)

CEN

EN ISO 21536:2007

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

9.11.2007

EN 12564:1998

Note 2.1

Date expired

(31.3.2008)

CEN

EN ISO 21647:2004

Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)

30.9.2005

EN 12598:1999

EN ISO 11196:1997

EN 864:1996

Note 2.1

Date expired

(31.5.2005)

EN ISO 21647:2004/AC:2006

2.6.2006

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 23328-2:2008

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

19.2.2009

EN 13328-2:2002

Note 2.1

Date expired

(30.9.2008)

CEN

EN ISO 23747:2007

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

27.2.2008

EN 13826:2003

Note 2.1

Date expired

(31.1.2008)

CEN

EN ISO 25539-1:2008

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

19.2.2009

EN 14299:2004

Note 2.1

30.9.2011

CEN

EN ISO 25539-2:2008

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

19.2.2009

EN 14299:2004

Note 2.1

30.9.2011

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)

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 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

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

Date expired

(1.9.2007)

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

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

Date expired

(1.12.2006)

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

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 60522:1999

Determination of the permanent filtration of X-ray tube assemblies IEC 60522:1999

14.11.2001

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

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

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

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

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

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 60580:2000

Medical electrical equipment — Dose area product meters IEC 60580:2000

13.12.2002

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

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

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

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

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 60601-1:1990

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 60601-2-27:2006

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

This is the first publication

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

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

EN 60601-2-33:2002/A2:2008 IEC 60601-2-33:2002/A2:2007

27.11.2008

Note 3

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 60601-1:2006

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 amendment

Date expired

(1.2.2003)

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

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

26.7.2006

Note 3

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 amendment

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

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

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 60601-2-45:2001

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 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

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

EN 61217:1996/A2:2008 IEC 61217:1996/A2:2007

27.11.2008

Note 3

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

This is the first publication

Cenelec

EN 62304:2006

Medical device software — Software life-cycle 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

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

Date expired

(1.11.2004)

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

| 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 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.

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 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 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 5196871, fax: +32 25196919 (http://www.cenelec.org).

ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, France, tel. +33 492944200, fax: +33 493654716 (http://www.etsi.org).

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

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

---