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Active Implantable Medical Devices

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Active Implantable Medical Devices

Directive 90/385/EEC

Short name:	Active Implantable Medical Devices
Base:	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 OJ No L 189/17 of 1990-07-20
Modification:	Directive 93/68/EEC [CE Marking] Directive 93/42/EEC [Medical devices]
Directives repealed:	76/117/EEC, 79/196/EEC (as at last amended by Directive 90/487/EEC), 82/130/EEC
Application Guide:	Guidelines relating to the demarcation between Directives 90/385/EC, 93/42/EC and 65/65/EC Guidelines on a Medical Devices Vigilance System
EC contact point for info on Directive only:	DG Enterprise & Industry Mr. M. Kohler Tel. +32 2 296 75 83, Fax. +32 2 296.70.13 e-mail: e ntr-cosm-med-dev@ec.europa.eu Website on Active Implantable Medical Devices

Publications in the Official Journal

Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 304 of 2008-11-27 (p. 5-6)

(This publication concerns a list of references of harmonised standards related to active implantable medical devices in the electrotechnical field.
This 'consolidated' list published in OJ C 304 incorporates European standards adopted by CENELEC only. This list replaces the previous lists of CENELEC standards published in the Official Journal of the European Union.)
Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 186 of 2008-07-23 (p. 28-31)

(This publication concerns a list of references of harmonised standards related to active implantable medical devices in the general field.
This 'consolidated' list published in OJ C 186 incorporates European standards adopted by CEN only. This list replaces the previous lists of CEN standards published in the Official Journal of the European Union.)
Earlier publications: view

Summary list of titles and references of harmonised standards relating to Active Implantable Medical Devices

The information contained in the summary list is a compilation of the references of standards which have been published in the Official Journal of the European Union.
It does not have any legal validity; only publication in the Official Journal produces legal affect.

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 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices	EN 556:1994 + A1:1998	Date expired (30.04.2002)
	EN 556-1:2001/AC:2006
CEN	EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices	—
CEN	EN 980:2008 Symbols for use in the labelling of medical devices	EN 980:2003	31.05.2010
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 (30.04.2003)
	EN ISO 10993-4:2002/A1:2006	Note 3	Date expired (31.01.2007)
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 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	EN 30993-6:1994	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)	—
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 (31.03.2003)
	EN ISO 10993-10:2002/A1:2006	Note 3	Date expired (31.01.2007)
CEN	EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	EN ISO 10993-11:1995	Date expired (28.02.2007)
CEN	EN ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	EN ISO 10993-12:2004	Date expired (31.05.2008)
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)	—
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 characterization of materials (ISO 10993-18:2005)	—
CEN	EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)	EN 550:1994	31.05.2010
CEN	EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)	EN 552:1994	30.04.2009
CEN	EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)	—
CEN	EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)	—
CEN	EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)	—
CEN	EN ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)	—
CEN	EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)	EN 868-1:1997	Date expired (30.04.2007)
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	Date expired (31.10.2006)
CEN	EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)	EN 46003:1999 EN ISO 13485:2000 EN ISO 13488:2000	31.07.2009
	EN ISO 13485:2003/AC:2007
CEN	EN 13824:2004 Sterilization 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 (31.08.2003)
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 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)	—
CEN	EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)	EN ISO 14971:2000	31.03.2010
CEN	EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)	EN 554:1994	31.08.2009
CEN/CENELEC	EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer	—
CEN/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)	—
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)	—
CENELEC	EN 60601-1:1990 Medical electrical equipment -- Part 1: General requirements for safety (IEC 60601-1:1988)	_	_
	Amendment A1:1993 to EN 60601-1:1990 (IEC 60601-1:1988/A1:1991)	Note 3	_
	Amendment A2:1995 to EN 60601-1:1990 (IEC 60601-1:1988/A2:1995)	Note 3	_
CENELEC	EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)	EN 60601-1:1990 and its amendments Note 2.1	_
CENELEC	EN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006)	_	_

(1) ESO: European Standardisation Organisation (for contact details of CEN, CENELEC, ETSI)

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.

Earlier publications in the Official Journal

The publications as of 2001 are downloadable hereunder. The publications as of 2008-07-23 are available here.

Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 54 of 2008-02-27 (p. 22-25)

(This publication concerns a list of references of harmonised standards related to active implantable medical devices in the general field.
This 'consolidated' list published in OJ C 54 incorporates European standards adopted by CEN only. This list replaces the previous lists of CEN standards published in the Official Journal of the European Union.)
Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 267 of 2007-11-09 (p. 28-30)

(This publication concerns a list of references of harmonised standards related to active implantable medical devices in the general field.
This 'consolidated' list published in OJ C 267 incorporates European standards adopted by CEN only.)
Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 186 of 2007-08-09 (p. 55-58)

(This publication concerns a list of references of harmonised standards related to active implantable medical devices in the general field.
This 'consolidated' list published in OJ C 186 incorporates European standards adopted by CEN only.)
Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 277 of 2006-11-15
Commission communication in relation to Council Directive 90/385/EC on active implantable medical devices
OJ C 216 of 2006-09-07
Commission communication in relation to Council Directive 90/385/EC on active implantable medical devices
OJ C 129 of 2006-06-02
Commission communication in relation to Council Directive 90/385/EEC on active implantable medical devices
OJ C 153 of 2005-06-24
Commission communication in relation to Directive 90/385/EEC on active implantable medical devices
OJ C 176 p. 3 of 2004-07-08
Commission communication in relation to Directive 93/42/EEC on medical devices, Directive 98/79/EC on in-vitro diagnostic medical devices and Directive 90/385/EEC on active implantable medical devices -
OJ C 83 p. 7 of 2004-04-02
Commission communication in relation to Directive 90/385/EEC on active implantable medical devices
OJ C 42 p. 14 of 2004-02-18
Commission communication in relation to Directive 90/385/EEC on active implantable medical devices and to Directive 93/42/EEC on medical devices
OJ C 270 p. 2 of 2003-11-11
Commission communication in relation to Directive 93/42/EEC on medical devices, Directive 98/79/EC on in-vitro diagnostic medical devices and Directive 90/385/EEC on active implantable medical devices
OJ C 32 p. 14 of 2003-02-11
Commission communication in relation to Directive 90/385/EEC on active implantable medical devices
OJ C 16 page 6 of 2003-01-23