歐盟有源植入醫療器械指令AIMDD90/385/EEC相關標準

The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.

ESO (1)	Reference and title of the harmonised standard (and reference document)	First publication OJ	Reference of superseded standard	Date of cessation of presumption of conformity of superseded standard Note 1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	31/07/2002	EN 556:1994 + A1:1998 Note 2.1	Date expired (30/04/2002)
CEN	EN 556-1:2001/AC:2006	15/11/2006
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	09/08/2007
CEN	EN 980:2008 Symbols for use in the labelling of medical devices	23/07/2008	EN 980:2003 Note 2.1	Date expired (31/05/2010)
CEN	EN 1041:2008 Information supplied by the manufacturer of medical devices	19/02/2009	EN 1041:1998 Note 2.1	31/08/2011
CEN	EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)	02/12/2009	EN ISO 10993-1:2009 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-1:2009/AC:2010 (new)	This is the first publication
CEN	EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)	02/12/2009	EN ISO 10993-4:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)	02/12/2009	EN ISO 10993-5:1999 Note 2.1	Date expired (31/12/2009)
CEN	EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)	02/12/2009	EN ISO 10993-6:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)	07/07/2010
CEN	EN ISO 10993-7:2008/AC:2009	07/07/2010
CEN	EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)	02/12/2009	EN ISO 10993-9:2009 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)	02/12/2009	EN ISO 10993-11:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)	02/12/2009	EN ISO 10993-12:2007 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-13:2010 (new) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)	This is the first publication	EN ISO 10993-13:2009 Note 2.1	31/12/2010
CEN	EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)	07/07/2010	EN ISO 10993-16:2009 Note 2.1	Date expired (31/08/2010)
CEN	EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)	02/12/2009	EN ISO 10993-17:2002 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)	02/12/2009	EN ISO 10993-18:2005 Note 2.1	Date expired (21/03/2010)
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)	09/08/2007	EN 550:1994 Note 2.1	Date expired (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)	07/09/2006	EN 552:1994 Note 2.1	Date expired (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)	09/08/2007
CEN	EN ISO 11137-2:2007/AC:2009	02/12/2009
CEN	EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)	02/12/2009	EN ISO 11138-2:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)	02/12/2009	EN ISO 11138-3:2006 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)	02/12/2009	EN ISO 11140-1:2005 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)	02/12/2009	EN ISO 11607-1:2006 Note 2.1	Date expired (21/03/2010)
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)	07/09/2006	EN 1174-2:1996 EN 1174-1:1996 EN 1174-3:1996 Note 2.1	Date expired (31/10/2006)
CEN	EN ISO 11737-1:2006/AC:2009	02/12/2009
CEN	EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)	07/07/2010
CEN	EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)	02/04/2004	EN ISO 13488:2000 EN ISO 13485:2000 Note 2.1	Date expired (31/07/2009)
CEN	EN ISO 13485:2003/AC:2009	07/07/2010
CEN	EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements	24/06/2005
CEN	EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)	07/07/2010	EN ISO 14155-1:2003 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)	07/07/2010	EN ISO 14155-2:2003 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 14937:2009 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 14937:2009)	07/07/2010	EN ISO 14937:2000 Note 2.1	Date expired (21/03/2010)
CEN	EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)	07/07/2010	EN ISO 14971:2007 Note 2.1	Date expired (21/03/2010)
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)	15/11/2006	EN 554:1994 Note 2.1	Date expired (31/08/2009)
CEN	EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer	27/08/1998
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)	24/06/2005
CEN	EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems	07/07/2010
Cenelec	EN 45502-1:1997 Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer	27/08/1998
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
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)	08/07/2004
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
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 45502-2-2:2008/AC:2009 (new)	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 45502-2-3:2010 (new) Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1:1990 Medical electrical equipment -- Part 1: General requirements for safety IEC 60601-1:1988	23/08/1996
	EN 60601-1:1990/A1:1993 IEC 60601-1:1988/A1:1991	23/08/1996	Note 3	The date of this publication ()
	EN 60601-1:1990/A2:1995 IEC 60601-1:1988/A2:1995	23/08/1996	Note 3	The date of this publication ()
	EN 60601-1:1990/AC:1994 (new)	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1:2006 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005	27/11/2008	EN 60601-1:1990 and its amendments Note 2.1	01/06/2012
Cenelec	EN 60601-1:2006/AC:2010 (new)	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 60601-1-6:2010 (new) Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec	EN 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006	27/11/2008
Cenelec	EN 62304:2006/AC:2008 (new)	This is the first publication
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

1) ESO: European Standardisation Organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.org)

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

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 2.2: 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 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.

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