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)
Date: 2009-12-02
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health








C_2009293EN.01003401.xml










2.12.2009   


EN


Official Journal of the European Union


C 293/34





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)
2009/C 293/02









European Standards Organisation (1)



Reference and title of the harmonised standard
(and reference document)


First publication in the Official Journal


Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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


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 (ISO 10993-1:2003)


This is the first publication


EN ISO 10993-1:2003
Note 2.1


21.3.2010




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)


This is the first publication


EN ISO 10993-4:2002
Note 2.1


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)


This is the first publication


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)


This is the first publication


EN ISO 10993-6:2007
Note 2.1


21.3.2010




CEN


EN ISO 10993-9:2009
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)


This is the first publication


EN ISO 10993-9:1999
Note 2.1


21.3.2010




CEN


EN ISO 10993-10:2009
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)


This is the first publication


EN ISO 10993-10:2002
Note 2.1


21.3.2010




CEN


EN ISO 10993-11:2009
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)


This is the first publication


EN ISO 10993-11:2006
Note 2.1


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)


This is the first publication


EN ISO 10993-12:2007
Note 2.1


21.3.2010




CEN


EN ISO 10993-13:2009
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)


This is the first publication


EN ISO 10993-13:1998
Note 2.1


21.3.2010




CEN


EN ISO 10993-16:2009
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)


This is the first publication


EN ISO 10993-16:1997
Note 2.1


21.3.2010




CEN


EN ISO 10993-17:2009
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)


This is the first publication


EN ISO 10993-17:2002
Note 2.1


21.3.2010




CEN


EN ISO 10993-18:2009
Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005)


This is the first publication


EN ISO 10993-18:2005
Note 2.1


21.3.2010




CEN


EN ISO 11135-1:2007
Sterilisation of healthcare 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


31.5.2010




CEN


EN ISO 11137-1:2006
Sterilisation of healthcare 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 healthcare 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


This is the first publication




CEN


EN ISO 11138-2:2009
Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006)


This is the first publication


EN ISO 11138-2:2006
Note 2.1


21.3.2010




CEN


EN ISO 11138-3:2009
Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006)


This is the first publication


EN ISO 11138-3:2006
Note 2.1


21.3.2010




CEN


EN ISO 11140-1:2009
Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)


This is the first publication


EN ISO 11140-1:2005
Note 2.1


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)


This is the first publication


EN ISO 11607-1:2006
Note 2.1


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


This is the first publication




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:2007


9.8.2007




CEN


EN 13824:2004
Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements


24.6.2005


 


 




CEN


EN ISO 14155-1:2003
Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)


11.11.2003


EN 540:1993
Note 2.1


Date expired
(31.8.2003)




CEN


EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)


11.11.2003


 


 




CEN


EN ISO 14937:2000
Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000)


31.7.2002


 


 




EN ISO 14937:2000/AC:2005


This is the first publication




CEN


EN ISO 14971:2007
Medical devices — Application of risk management to medical devices (ISO 14971:2007)


9.8.2007


EN ISO 14971:2000
Note 2.1


31.3.2010




CEN


EN ISO 17665-1:2006
Sterilisation of healthcare 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


 


 




Cenelec


EN 45502-1:1997
Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer


27.8.1998


 


 




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)


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)


27.11.2008


 


 




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


 




EN 60601-1:1990/A2:1995
IEC 60601-1:1988/A2:1995


23.8.1996


Note 3


 




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


 




Cenelec


EN 62304:2006
Medical device software — Software lifecycle processes
IEC 62304:2006


27.11.2008


 


 










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 (2) amended by the Directive 98/48/EC (3).










—


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 on the Internet at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/






(1)  CEN: Avenue Marnix 17, 1000 Brussels, BELGIUM, tel. +32 25500811, fax: +32 25500819 (http://www.cen.eu).
Cenelec: Avenue Marnix 17, 1000 Brussels, BELGIUM, 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)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.