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  Text with EEA relevance (Publication of titles and references of harmonised standards under the directive)
Date: 2012-04-27
Institutions: European Commission
Subjects: Cenelec, European Committee for Standardisation, approximation of laws, marketing, medical device








C_2012123EN.01000101.xml










27.4.2012   


EN


Official Journal of the European Union


C 123/1





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
(Text with EEA relevance)
(Publication of titles and references of harmonised standards under the directive)
2012/C 123/01









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Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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




(1)


(2)


(3)


(4)


(5)




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


31.7.2002


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
Sterilization 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


Date expired
(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


18.1.2011


 


 




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)


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 sterilization 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)


18.1.2011


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)


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 characterization 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
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)


9.8.2007


EN 550:1994
Note 2.1


Date expired
(31.5.2010)




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)


7.9.2006


EN 552:1994
Note 2.1


Date expired
(30.4.2009)




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)


9.8.2007


 


 




EN ISO 11137-2:2007/AC:2009


2.12.2009


 


 




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)


2.12.2009


EN ISO 11138-2:2006
Note 2.1


Date expired
(21.3.2010)




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)


2.12.2009


EN ISO 11138-3:2006
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 11140-1:2009
Sterilization 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 sterilized 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
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms 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
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)


7.7.2010


 


 




CEN


EN ISO 13408-1:2011
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)


19.8.2011


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)


19.8.2011


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)


19.8.2011


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)


19.8.2011


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)


19.8.2011


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)


19.8.2011


EN 13824:2004
Note 2.1


Date expired
(31.12.2011)




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


27.4.2012


EN ISO 14155:2011
Note 2.1


30.4.2012




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
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)


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
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
(31.8.2009)




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


18.1.2011


 


 




Cenelec


EN 45502-2-3:2010
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems (2)



18.1.2011


 


 




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


Date expired
(7.7.2010)




EN 60601-1:1990/A2:1995
IEC 60601-1:1988/A2:1995 (2)



23.8.1996


Note 3


Date expired
(7.7.2010)




EN 60601-1:1990/AC:1994


18.1.2011


 


 




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


18.1.2011


 


 




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)



18.1.2011


 


 




Cenelec


EN 62304:2006
Medical device software - Software life-cycle processes
IEC 62304:2006 (2)



27.11.2008


 


 




EN 62304:2006/AC:2008


18.1.2011


 


 










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 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 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/BELGIË, Tel. +32 25500811; fax +32 25500819 (http://www.cen.eu)










—


Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, 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.