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European standards

Active implantable medical devices

Directive 90/385/EEC

Short name:

Active Implantable Medical Devices

Base:

Council Directive 90/385/EECof 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
OJ No L 189 of 20 July 1990

Modification:

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  • Directive 93/68/EEC [CE Marking]
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directives repealed:

76/117/EEC,
79/196/EEC (as at last amended by Directive 90/487/EEC),
82/130/EEC

Guide for application:

EC contact point:

Directorate General for Health and Consumers 
DG SANCO - Cosmetics and Medical Devices, Tel +32 2 2995820 
E-mail
Website on Medical Devices

For information about the content and availability of European standards, please contact the European Standardisation Organisations.

 

Publications in the Official Journal:

  • 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 - OJ C 022 of 24/01/2013
    BG CS DA DE EL EN ES ET FI FR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format
    (This list replaces all the previous lists published in the Official Journal.)


  • Stay up to date with the references of harmonised standards for this Directive, published in the Offical Journal by subcribing to the RSS feed  RSS

    Summary list of titles and references harmonised standards under Directive 90/385/EEC for Active implantable medical devices

    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 effect.

     

    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 1041:2008

    Information supplied by the manufacturer of medical devices

    19/02/2009 

    EN 1041:1998

    Note 2.1 

    Date expired
    (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

    18/01/2011 

     

     

    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 10993-12:2012 (new)

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    This is the first publication 

    EN ISO 10993-12:2009

    Note 2.1 

    31/01/2013 

    CEN

    EN ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

    18/01/2011 

    EN ISO 10993-13:2009

    Note 2.1 

    Date expired
    (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 11137-2:2012

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

    30/08/2012 

    EN ISO 11137-2:2007

    Note 2.1 

    Date expired
    (30/09/2012) 

    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 13408-1:2011

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-2:2011

    Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-3:2011

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-4:2011

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-5:2011

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13408-6:2011

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    19/08/2011 

    EN 13824:2004

    Note 2.1 

    Date expired
    (31/12/2011) 

    CEN

    EN ISO 13485:2012

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

    30/08/2012 

    EN ISO 13485:2003

    Note 2.1 

    Date expired
    (30/08/2012) 

    EN ISO 13485:2012/AC:2012

    30/08/2012 

     

     

    CEN

    EN ISO 14155:2011

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    27/04/2012 

    EN ISO 14155:2011

    Note 2.1 

    Date expired
    (30/04/2012) 

    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 14971:2012

    Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

    30/08/2012 

    EN ISO 14971:2009

    Note 2.1 

    Date expired
    (30/08/2012) 

    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

    18/01/2011 

     

     

    (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

    Cenelec

    EN 45502-2-3:2010

    Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

    18/01/2011 

     

     

    (*): 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

    27/11/2008 

    EN 60601-1:1990
    + A1:1993
    + A2:1995
    + A13:1996

    Note 2.1 

    Date expired
    (01/06/2012) 

    EN 60601-1:2006/AC:2010

    18/01/2011 

     

     

    (*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

    Cenelec

    EN 60601-1-6:2010

    Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

    18/01/2011 

     

     

    (*): 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

    27/11/2008 

     

     

    EN 62304:2006/AC:2008

    18/01/2011 

     

     

    (*): 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.eu)

    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 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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