Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (Publication of titles and references of harmonised standards under Union harmonisation legislation)Text with EEA relevance.
Date: 2017-11-17
Institutions: European Commission
Subjects: Cenelec, European Committee for Standardisation, European standard, harmonisation of standards, medical device








C_2017389EN.01006201.xml










17.11.2017   


EN


Official Journal of the European Union


C 389/62





Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
(Text with EEA relevance)
(2017/C 389/04)









ESO (1)



Reference and title of the 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Reference of superseded standard


Date of cessation of presumption of conformity of superseded standard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


30.4.2002




 


EN 556-1:2001/AC:2006


15.11.2006


 


 




CEN


EN 556-2:2015
Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices


13.5.2016


EN 556-2:2003
Note 2.1


30.6.2016




CEN


EN ISO 11137-1:2015
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, including Amd 1:2013)


This is the first publication


 


 




CEN


EN ISO 11137-2:2015
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)


13.5.2016


EN ISO 11137-2:2013
Note 2.1


30.6.2016




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 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


30.4.2002




CEN


EN ISO 13408-1:2015
Aseptic processing of health care products — Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)


13.5.2016


EN ISO 13408-1:2011
Note 2.1


30.6.2016




CEN


EN ISO 13408-2:2011
Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)


19.8.2011


 


 




CEN


EN ISO 13408-3:2011
Aseptic processing of health care products — Part 3: Lyophilization (ISO 13408-3:2006)


19.8.2011


 


 




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


 


 




CEN


EN ISO 13408-5:2011
Aseptic processing of health care products — Part 5: Sterilization in place (ISO 13408-5:2006)


19.8.2011


 


 




CEN


EN ISO 13408-6:2011
Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2005)


19.8.2011


 


 




CEN


EN ISO 13408-7:2015
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)


13.5.2016


 


 




CEN


EN ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)


This is the first publication


EN ISO 13485:2012
Note 2.1


31.3.2019




 


EN ISO 13485:2016/AC:2016


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 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)


7.7.2010


EN ISO 14937:2000
Note 2.1


30.4.2010




CEN


EN ISO 14971:2012
Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)


30.8.2012


EN ISO 14971:2009
Note 2.1


30.8.2012




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)


7.7.2010


 


 




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)


7.7.2010


 


 




CEN


EN ISO 15197:2015
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)


13.5.2016


EN ISO 15197:2013
Note 2.1


31.7.2016




For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30.6.2017.




CEN


EN ISO 15223-1:2016
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)


This is the first publication


EN 980:2008
Note 2.1


31.12.2017




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 18113-1:2011
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)


27.4.2012


EN ISO 18113-1:2009
Note 2.1


30.4.2012




CEN


EN ISO 18113-2:2011
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)


27.4.2012


EN ISO 18113-2:2009
Note 2.1


30.4.2012




CEN


EN ISO 18113-3:2011
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)


27.4.2012


EN ISO 18113-3:2009
Note 2.1


30.4.2012




CEN


EN ISO 18113-4:2011
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)


27.4.2012


EN ISO 18113-4:2009
Note 2.1


30.4.2012




CEN


EN ISO 18113-5:2011
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)


27.4.2012


EN ISO 18113-5:2009
Note 2.1


30.4.2012




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


 


 




CEN


EN ISO 23640:2015
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)


13.5.2016


EN 13640:2002
Note 2.1


30.6.2017




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


 


 




 


EN 62304:2006/AC:2008


18.1.2011


 


 




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 or other requirements of the relevant Union legislation.










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 or other requirements of the relevant Union legislation.










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 or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services 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 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 or other requirements of the relevant Union legislation.




NOTE:






—


Any information concerning the availability of the standards can be obtained either from the European standardisation organisations or from the national standardisation bodies the list of which is published in the Official Journal of the European Union according to Article 27 of the Regulation (EU) No 1025/2012 (2).










—


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










—


References to Corrigenda ‘…/AC:YYYY’ are published for information only. A Corrigendum removes printing, linguistic or similar errors from the text of a standard and may relate to one or more language versions (English, French and/or German) of a standard as adopted by a European standardisation organisation.










—


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










—


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










—


More information about harmonised standards and other European standards on the Internet at
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm






(1)  ESO: European standardisation organisation:






—


CEN: Avenue Marnix 17, B-1000, Brussels, Tel. +32 2 5500811; fax + 32 2 5500819 (http://www.cen.eu)










—


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










—


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





(2)  OJ C 338, 27.9.2014, p. 31.