Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices  (Text with EEA relevance) (Publication of titles and references of harmonised standards under the directive)
Date: 2010-07-07
Institutions: European Commission
Subjects: approximation of laws, artificial reproduction, medical device, medical diagnosis, public health, single market








C_2010183EN.01004501.xml










7.7.2010   


EN


Official Journal of the European Union


C 183/45





Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
(Text with EEA relevance)

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

2010/C 183/04









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Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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


31.7.2002


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 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)


This is the first publication


 


 




CEN


EN 12322:1999
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media


9.10.1999


 


 




EN 12322:1999/A1:2001


31.7.2002


Note 3


Date expired
(30.4.2002)




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


This is the first publication


 


 




CEN


EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing


17.12.2002


 


 




CEN


EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices


17.12.2002


 


 




EN 13612:2002/AC:2002


2.12.2009


 


 




CEN


EN 13640:2002
Stability testing of in vitro diagnostic reagents


17.12.2002


 


 




CEN


EN 13641:2002
Elimination or reduction of risk of infection related to in vitro diagnostic reagents


17.12.2002


 


 




CEN


EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects


21.11.2003


 


 




CEN


EN 14136:2004
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures


15.11.2006


 


 




CEN


EN 14254:2004
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans


28.4.2005


 


 




CEN


EN 14820:2004
Single-use containers for human venous blood specimen collection


28.4.2005


 


 




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)


This is the first publication


EN ISO 14937:2000
Note 2.1


Date expired
(30.4.2010)




CEN


EN ISO 14971:2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)


This is the first publication


EN ISO 14971:2007
Note 2.1


Date expired
(21.3.2010)




CEN


EN ISO 15193:2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)


This is the first publication


 


 




CEN


EN ISO 15194:2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)


This is the first publication


 


 




CEN


EN ISO 15197:2003
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)


28.4.2005


 


 




EN ISO 15197:2003/AC:2005


2.12.2009


 


 




CEN


EN ISO 15225:2000
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)


31.7.2002


 


 




EN ISO 15225:2000/A1:2004


2.12.2009


Note 3


Date expired
(31.8.2004)




EN ISO 15225:2000/A2:2005


2.12.2009


Note 3


Date expired
(31.1.2006)




CEN


EN ISO 17511:2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)


28.4.2005


 


 




CEN


EN ISO 18113-1:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)


This is the first publication


 


 




CEN


EN ISO 18113-2:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)


This is the first publication


EN 375:2001
Note 2.1


31.12.2012




CEN


EN ISO 18113-3:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)


This is the first publication


EN 591:2001
Note 2.1


31.12.2012




CEN


EN ISO 18113-4:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)


This is the first publication


EN 376:2002
Note 2.1


31.12.2012




CEN


EN ISO 18113-5:2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)


This is the first publication


EN 592:2002
Note 2.1


31.12.2012




CEN


EN ISO 18153:2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)


21.11.2003


 


 




CEN


EN ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)


9.8.2007


 


 




Cenelec


EN 61010-2-101:2002
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2002 (Modified)


17.12.2002


 


 




Cenelec


EN 61326-2-6:2006
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61326-2-6:2005


27.11.2008


 


 




Cenelec


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


27.11.2008


 


 




Cenelec


EN 62366:2008
Medical devices - Application of usability engineering to medical devices
IEC 62366:2007


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










—


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, Brussels, BELGIUM, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)










—


CENELEC: Avenue Marnix 17, 1000, Brussels, BELGIUM, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)










—


ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)





(2)  OJ L 204, 21.7.1998, p. 37


(3)  OJ L 217, 5.8.1998, p. 18