EN Official Journal of the European Union C 16/1

Commission communication in the framework of the implementation of 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

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

2011/C 16/01

ESO (1) Reference and title of the harmonised standard (and reference document) First publication OJ Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1 CEN EN 556-1:2001 Sterilisation of medical devices — Requirements for medical devices to be designated ‘Sterile’ — Part 1: Requirements for terminally sterilised medical devices 31.7.2002 EN 556:1994 + A1:1998 Note 2.1 Date expired (30.4.2002) EN 556-1:2001/AC:2006 15.11.2006 CEN EN 556-2:2003 Sterilisation of medical devices — Requirements for medical devices to be designated ‘Sterile’ — Part 2: Requirements for aseptically processed medical devices 9.8.2007 CEN EN 980:2008 Symbols for use in the labelling of medical devices 23.7.2008 EN 980:2003 Note 2.1 Date expired (31.5.2010) CEN EN 1041:2008 Information supplied by the manufacturer of medical devices 19.2.2009 EN 1041:1998 Note 2.1 31.8.2011 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) 2.12.2009 EN ISO 10993-1:2009 Note 2.1 Date expired (21.3.2010) EN ISO 10993-1:2009/AC:2010 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) 2.12.2009 EN ISO 10993-4:2002 Note 2.1 Date expired (21.3.2010) CEN EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 2.12.2009 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) 2.12.2009 EN ISO 10993-6:2007 Note 2.1 Date expired (21.3.2010) CEN EN ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilisation residuals (ISO 10993-7:2008) 7.7.2010 EN ISO 10993-7:2008/AC:2009 7.7.2010 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) 2.12.2009 EN ISO 10993-9:2009 Note 2.1 Date expired (21.3.2010) CEN EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) 2.12.2009 EN ISO 10993-11:2006 Note 2.1 Date expired (21.3.2010) CEN EN ISO 10993-12:2009 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) 2.12.2009 EN ISO 10993-12:2007 Note 2.1 Date expired (21.3.2010) 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) This is the first publication 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: Toxico-kinetic study design for degradation products and leachables (ISO 10993-16:2010) 7.7.2010 EN ISO 10993-16:2009 Note 2.1 Date expired (31.8.2010) CEN EN ISO 10993-17:2009 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) 2.12.2009 EN ISO 10993-17:2002 Note 2.1 Date expired (21.3.2010) CEN EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) 2.12.2009 EN ISO 10993-18:2005 Note 2.1 Date expired (21.3.2010) CEN EN ISO 11135-1:2007 Sterilisation of health-care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007) 9.8.2007 EN 550:1994 Note 2.1 Date expired (31.5.2010) CEN EN ISO 11137-1:2006 Sterilisation of health-care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) 7.9.2006 EN 552:1994 Note 2.1 Date expired (30.4.2009) CEN EN ISO 11137-2:2007 Sterilisation of health-care products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01) 9.8.2007 EN ISO 11137-2:2007/AC:2009 2.12.2009 CEN EN ISO 11138-2:2009 Sterilisation of health-care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) 2.12.2009 EN ISO 11138-2:2006 Note 2.1 Date expired (21.3.2010) CEN EN ISO 11138-3:2009 Sterilisation of health-care products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) 2.12.2009 EN ISO 11138-3:2006 Note 2.1 Date expired (21.3.2010) CEN EN ISO 11140-1:2009 Sterilisation of health-care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) 2.12.2009 EN ISO 11140-1:2005 Note 2.1 Date expired (21.3.2010) CEN EN ISO 11607-1:2009 Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) 2.12.2009 EN ISO 11607-1:2006 Note 2.1 Date expired (21.3.2010) CEN EN ISO 11737-1:2006 Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms on products (ISO 11737-1:2006) 7.9.2006 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 2.12.2009 CEN EN ISO 11737-2:2009 Sterilisation of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilisation process (ISO 11737-2:2009) 7.7.2010 CEN EN ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) 2.4.2004 EN ISO 13488:2000 EN ISO 13485:2000 Note 2.1 Date expired (31.7.2009) EN ISO 13485:2003/AC:2009 7.7.2010 CEN EN 13824:2004 Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements 24.6.2005 CEN EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) 7.7.2010 EN ISO 14155-1:2003 Note 2.1 Date expired (21.3.2010) CEN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) 7.7.2010 EN ISO 14155-2:2003 Note 2.1 Date expired (21.3.2010) CEN EN ISO 14937:2009 Sterilisation of health-care products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2009) 7.7.2010 EN ISO 14937:2000 Note 2.1 Date expired (21.3.2010) CEN EN ISO 14971:2009 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 7.7.2010 EN ISO 14971:2007 Note 2.1 Date expired (21.3.2010) CEN EN ISO 17665-1:2006 Sterilisation of health-care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices (ISO 17665-1:2006) 15.11.2006 EN 554:1994 Note 2.1 Date expired (31.8.2009) CEN EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer 27.8.1998 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) 24.6.2005 CEN EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems 7.7.2010 Cenelec EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer (2) 27.8.1998 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) (2) 8.7.2004 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) (2) 27.11.2008 EN 45502-2-2:2008/AC:2009 This is the first publication Cenelec EN 45502-2-3:2010 Active implantable medical devices — Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems (2) This is the first publication Cenelec EN 60601-1:1990 Medical electrical equipment — Part 1: General requirements for safety IEC 60601-1:1988 23.8.1996 EN 60601-1:1990/A1:1993 IEC 60601-1:1988/A1:1991 23.8.1996 Note 3 The date of this publication EN 60601-1:1990/A2:1995 IEC 60601-1:1988/A2:1995 (2) 23.8.1996 Note 3 The date of this publication EN 60601-1:1990/AC:1994 This is the first publication Cenelec EN 60601-1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 (2) 27.11.2008 EN 60601-1:1990 and its amendments Note 2.1 1.6.2012 EN 60601-1:2006/AC:2010 This is the first publication 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 (2) This is the first publication Cenelec EN 62304:2006 Medical device software — Software life-cycle processes IEC 62304:2006 (2) 27.11.2008 EN 62304:2006/AC:2008 This is the first publication

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.

NOTE:

— Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and of the Council (3) amended by the Directive 98/48/EC (4).

— Harmonised standards are adopted by the European Standardisation Organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the harmonised standards are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal.

— Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

— This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

— More information about harmonised standards is available on the Internet at: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

(1) ESO: European Standards Organisation:

— CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIЁ, Tel. +32 25500811; Fax +32 25500819 (http://www.cen.eu),

— Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIЁ, Tel. +32 25196871; Fax +32 25196919 (http://www.cenelec.eu),

— ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; Fax +33 493654716 (http://www.etsi.eu).

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

(3) OJ L 204, 21.7.1998, p. 37.

(4) OJ L 217, 5.8.1998, p. 18.