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Active implantable medical devices

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 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Directives repealed: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 Internal Market, Industry, Entrepreneurship and SMEs
Health Technology and Cosmetics, 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:

 

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

 

Summary list of titles and references of 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.

 

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

ESO (1)

Reference and title of the 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Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard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 

30/04/2002 

EN 556-1:2001/AC:2006

 

15/11/2006 

 

 

CEN

EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

13/05/2016 

EN 556-2:2003

Note 2.1 

30/06/2016 

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 

21/03/2010 

EN ISO 10993-1:2009/AC:2010

 

18/01/2011 

 

 

CEN

EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

10/07/2015 

 

 

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 

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 

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 

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 

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 

21/03/2010 

CEN

EN ISO 10993-12:2012

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

24/01/2013 

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 

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 

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 

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 

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 

31/05/2010 

CEN

EN ISO 11137-1:2015

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, including Amd 1:2013)

13/05/2016 

EN ISO 11137-1:2006

Note 2.1 

30/06/2016 

CEN

EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

13/05/2016 

EN ISO 11137-2:2013

Note 2.1 

30/06/2016 

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 

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 

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 

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 

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 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996


Note 2.1 

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 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

13/05/2016 

EN ISO 13408-1:2011

Note 2.1 

30/06/2016 

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 

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 

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 

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 

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 

31/12/2011 

CEN

EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

13/05/2016 

 

 

CEN

EN ISO 13485:2016 (new)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

This is the first publication 

EN ISO 13485:2012

Note 2.1 

31/03/2019 

EN ISO 13485:2016/AC:2016 (new)

 

This is the first publication 

 

 

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 

30/04/2012 

EN ISO 14155:2011/AC:2011 (new)

 

This is the first publication 

 

 

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 

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 

30/08/2012 

CEN

EN ISO 15223-1:2016 (new)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)

This is the first publication 

EN 980:2008

Note 2.1 

31/12/2017 

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 

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 

 

 

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
IEC 60601-1:2005

27/11/2008 

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

Note 2.1 

01/06/2012 

EN 60601-1:2006/AC:2010

 

18/01/2011 

 

 

EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012

 

10/07/2015 

Note 3 

31/12/2017 

Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006.
The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31/12/2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 90/385/EEC on 31/12/2015. As from 01/01/2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 90/385/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.

Cenelec

EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-6:2010

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
IEC 62304:2006

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 or other requirements of the relevant Union legislation.

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 or other requirements of the relevant Union legislation.

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 or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services 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 or other requirements of the relevant Union legislation.

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