Commission communication in the framework of the implementation of 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: 2009-12-02
Institutions: European Commission
Subjects: European standard, artificial reproduction, harmonisation of standards, medical device, medical diagnosis








C_2009293EN.01006901.xml










2.12.2009   


EN


Official Journal of the European Union


C 293/69





Commission communication in the framework of the implementation of 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)
2009/C 293/04









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Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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 375:2001
Information supplied by the manufacturer with in-vitro diagnostic reagents for professional use


31.7.2002


 


 




CEN


EN 376:2002
Information supplied by the manufacturer with in-vitro diagnostic reagents for self-testing


31.7.2002


 


 




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 591:2001
Instructions for use for in-vitro diagnostic instruments for professional use


31.7.2002


 


 




CEN


EN 592:2002
Instructions for use for in-vitro diagnostic instruments for self-testing


31.7.2002


 


 




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 ISO 10993-14:2009
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)


This is the first publication


 


 




CEN


EN ISO 10993-15:2009
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)


This is the first publication


 


 




CEN


EN 12286:1998
In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures


10.8.1999


 


 




EN 12286:1998/A1:2000


14.11.2001


Note 3


Date expired
(24.11.2000)




CEN


EN 12287:1999
In-vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials


14.10.2000


 


 




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:2007


9.8.2007




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


This is the first publication




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 14937:2000
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 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


This is the first publication




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


This is the first publication


Note 3


Date expired
(31.8.2004)




EN ISO 15225:2000/A2:2005


This is the first publication


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 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 lifecycle 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 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.