# C_2009163EN.01000101.xml

| 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  (and reference document) | First publication in the Official Journal | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard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)

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)

in-vitro

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).

2

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.

Official Journal of the European Union

| — | 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.

Official Journal of the European Union

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

—

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

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

1

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.

2

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

3

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