# C_2006216EN.01001701.xml

| 7.9.2006 | EN | Official Journal of the European Union | C 216/17 |
| --- | --- | --- | --- |

7.9.2006

EN

Official Journal of the European Union

C 216/17

---

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

(2006/C 216/02)

(Text with EEA relevance)

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

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- |
| CEN | EN 550:1994
  Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation | — | |
| CEN | EN 554:1994
  Sterilisation of medical devices — Validation and routine control of sterilization by moist heat | — | |
| 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 | EN 556:1994 + A1:1998 | Date expired
  (30.4.2002) |
| 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 | — | |
| CEN | EN 980:2003
  Graphical symbols for use in the labelling of medical devices | EN 980:1996 | Date expired
  (31.10.2003) |
| CEN | EN 1041:1998
  Information supplied by the manufacturer with medical devices | — | |
| CEN | EN ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | — | |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | EN 30993-4:1993 | Date expired
  (30.4.2003) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | EN 30993-5:1994 | Date expired
  (30.11.1999) |
| 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) | — | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | EN ISO 10993-10:1995 | Date expired
  (31.3.2003) |
| CEN | EN ISO 10993-11:1995
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993) | — | |
| CEN | EN ISO 10993-12:2004
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2002) | EN ISO 10993-12:1996 | Date expired
  (31.5.2005) |
| 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) | — | |
| 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) | — | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | — | |
| CEN | EN ISO 10993-18:2005
  Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) | — | |
| CEN | EN ISO 11137-1:2006
  Sterilization of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11137-2:2006
  Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006) | EN 552:1994 | 30.4.2009 |
| CEN | EN ISO 11140-1:2005
  Sterilization of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) | — | |
| 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) | EN 868-1:1997 | Date expired
  (30.4.2006) |
| CEN | EN ISO 11737-1:2006
  Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) | EN 1174-1:1996
  EN 1174-2:1996
  EN 1174-3:1996 | 31.10.2006 |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13485:2000
  EN ISO 13488:2000 | 31.7.2006 |
| CEN | EN 13824:2004
  Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements | — | |
| CEN | EN ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | EN 540:1993 | 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) | — | |
| CEN | EN ISO 14971:2000
  Medical devices — Application of risk management to medical devices (ISO 14971:2000) | EN 1441:1997 | Date expired
  (31.3.2004) |
| | EN ISO 14971:2000/A1:2003 | Note 3 | Date expired
  (31.3.2004) |
| CEN | EN 30993-6:1994
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994) | — | |
| CEN | EN 45502-1:1997
  Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer | — | |
| 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) | — | |

ESO (1)

1

Reference and title of the harmonised standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 550:1994

Sterilisation of medical devices — Validation and routine control of ethylene oxide sterilisation

—

CEN

EN 554:1994

Sterilisation of medical devices — Validation and routine control of sterilization by moist heat

—

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

EN 556:1994 + A1:1998

Date expired

(30.4.2002)

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

—

CEN

EN 980:2003

Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date expired

(31.10.2003)

CEN

EN 1041:1998

Information supplied by the manufacturer with medical devices

—

CEN

EN ISO 10993-1:2003

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

—

CEN

EN ISO 10993-4:2002

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

EN 30993-4:1993

Date expired

(30.4.2003)

CEN

EN ISO 10993-5:1999

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

EN 30993-5:1994

Date expired

(30.11.1999)

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)

—

CEN

EN ISO 10993-10:2002

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

EN ISO 10993-10:1995

Date expired

(31.3.2003)

CEN

EN ISO 10993-11:1995

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

—

CEN

EN ISO 10993-12:2004

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

EN ISO 10993-12:1996

Date expired

(31.5.2005)

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)

—

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)

—

CEN

EN ISO 10993-17:2002

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

—

CEN

EN ISO 10993-18:2005

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

—

CEN

EN ISO 11137-1:2006

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

EN 552:1994

30.4.2009

CEN

EN ISO 11137-2:2006

Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

EN 552:1994

30.4.2009

CEN

EN ISO 11140-1:2005

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

—

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)

EN 868-1:1997

Date expired

(30.4.2006)

CEN

EN ISO 11737-1:2006

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

EN 1174-1:1996

EN 1174-2:1996

EN 1174-3:1996

31.10.2006

CEN

EN ISO 13485:2003

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

EN ISO 13485:2000

EN ISO 13488:2000

31.7.2006

CEN

EN 13824:2004

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

—

CEN

EN ISO 14155-1:2003

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

EN 540:1993

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)

—

CEN

EN ISO 14971:2000

Medical devices — Application of risk management to medical devices (ISO 14971:2000)

EN 1441:1997

Date expired

(31.3.2004)

EN ISO 14971:2000/A1:2003

Note 3

Date expired

(31.3.2004)

CEN

EN 30993-6:1994

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994)

—

CEN

EN 45502-1:1997

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

—

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)

—

| 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 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |

Note 1

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 3

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

and

without

Note:

Note:

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

—

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

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://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

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(1)  ESO: European Standardisation Organisation:

1

| — | CEN: rue de Stassart 36, B-1050 Brussels, Tel.: (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, Tel.: (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)

| — | CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.: (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
| --- | --- |

—

CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.: (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax: (33) 493 65 47 16 (http://www.etsi.org) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax: (33) 493 65 47 16 (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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