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European standards

In vitro diagnostic medical devices

Directive 98/79/EC

Short name:

In vitro diagnostic medical devices

Base:

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
OJ L 331 of 7 December 1998

Modification:

[-]

Guide for application:

EC contact point:

Directorate General for Health and Consumers 
DG SANCO B2 - Cosmetics and Medical Devices, Tel. +32 2 2995820
E-mail
Website on medical devices directives

For information about the content and availability of European standards, please contact the European Standardisation Organisations.

 

Publications in the Official Journal:

  • 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 - OJ C 022 of 24/01/2013
    BG CS DA DE EL EN ES ET FI FR HU IT LT LV MT NL PL PT RO SK SL SV PDF Format
    (This list replaces all the previous lists published in the Official Journal.)


  • Stay up to date with the references of harmonised standards for this Directive, published in the Offical Journal by subcribing to the RSS feed  RSS

    Summary list of titles and references harmonised standards under Directive 98/79/EC for In vitro diagnostic medical devices

    The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
    Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal effect.

     

    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    Reference of superseded standard

    Date of cessation of presumption of conformity of superseded standard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

    31/07/2002 

    EN 556:1994 + A1:1998

    Note 2.1 

    Date expired
    (30/04/2002) 

    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

    09/08/2007 

     

     

    CEN

    EN ISO 11137-2:2012 (new)

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

    This is the first publication 

     

     

    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)

    07/07/2010 

     

     

    CEN

    EN 12322:1999

    In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

    09/10/1999 

     

     

    EN 12322:1999/A1:2001

    31/07/2002 

    Note 3 

    Date expired
    (30/04/2002) 

    CEN

    EN ISO 13408-1:2011

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

    19/08/2011 

     

     

    CEN

    EN ISO 13408-2:2011

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

    19/08/2011 

     

     

    CEN

    EN ISO 13408-3:2011

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

    19/08/2011 

     

     

    CEN

    EN ISO 13408-4:2011

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    19/08/2011 

     

     

    CEN

    EN ISO 13408-5:2011

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

    19/08/2011 

     

     

    CEN

    EN ISO 13408-6:2011

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

    19/08/2011 

     

     

    CEN

    EN ISO 13485:2012

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

    30/08/2012 

    EN ISO 13485:2003

    Note 2.1 

    Date expired
    (31/08/2012) 

    EN ISO 13485:2012/AC:2012

    30/08/2012 

     

     

    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

    02/12/2009 

     

     

    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

    28/04/2005 

     

     

    CEN

    EN 14820:2004

    Single-use containers for human venous blood specimen collection

    28/04/2005 

     

     

    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)

    07/07/2010 

    EN ISO 14937:2000

    Note 2.1 

    Date expired
    (30/04/2010) 

    CEN

    EN ISO 14971:2012

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

    30/08/2012 

    EN ISO 14971:2009

    Note 2.1 

    Date expired
    (30/08/2012) 

    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)

    07/07/2010 

     

     

    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)

    07/07/2010 

     

     

    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)

    28/04/2005 

     

     

    EN ISO 15197:2003/AC:2005

    02/12/2009 

     

     

    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)

    28/04/2005 

     

     

    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)

    27/04/2012 

    EN ISO 18113-1:2009

    Note 2.1 

    Date expired
    (30/04/2012) 

    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)

    27/04/2012 

    EN ISO 18113-2:2009

    Note 2.1 

    Date expired
    (30/04/2012) 

    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)

    27/04/2012 

    EN ISO 18113-3:2009

    Note 2.1 

    Date expired
    (30/04/2012) 

    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)

    27/04/2012 

    EN ISO 18113-4:2009

    Note 2.1 

    Date expired
    (30/04/2012) 

    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)

    27/04/2012 

    EN ISO 18113-5:2009

    Note 2.1 

    Date expired
    (30/04/2012) 

    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)

    09/08/2007 

     

     

    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

    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

    27/11/2008 

     

     

    Cenelec

    EN 62304:2006

    Medical device software - Software life-cycle processes

    27/11/2008 

     

     

    EN 62304:2006/AC:2008

    18/01/2011 

     

     

    Cenelec

    EN 62366:2008

    Medical devices - Application of usability engineering to medical devices

    27/11/2008 

     

     

     

    (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)

     

    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 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.

     

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