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        歐盟有源植入醫療器械指令AIMDD90/385/EEC相關標準
         

        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        Reference of superseded standard

        Date of cessation of presumption of conformity of superseded standard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)

        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)

        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

        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

        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)

        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)

        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

        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

        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

        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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