Growth

In vitro diagnostic medical devices

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:

Commission contact point:

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Health Technology and Cosmetics, Tel. +32 2 299 5820
Email
Webpage 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:

 

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

 

Summary list of titles and references of 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.

 

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

 

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Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard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

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 

30/04/2002 

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

13/05/2016 

EN 556-2:2003

Note 2.1 

30/06/2016 

CEN

EN ISO 11137-1:2015 (new)

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)

13/05/2016 

EN ISO 11137-2:2013

Note 2.1 

30/06/2016 

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)

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 

30/04/2002 

CEN

EN ISO 13408-1:2015

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

13/05/2016 

EN ISO 13408-1:2011

Note 2.1 

30/06/2016 

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 13408-7:2015

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

13/05/2016 

 

 

CEN

EN ISO 13485:2016 (new)

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

This is the first publication 

EN ISO 13485:2012

Note 2.1 

31/03/2019 

EN ISO 13485:2016/AC:2016 (new)

 

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

 

02/12/2009 

 

 

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

28/04/2005 

 

 

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 

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 

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 15197:2015

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

13/05/2016 

EN ISO 15197:2013

Note 2.1 

31/07/2016 

For blood glucose test strips and control solutions, the date of cessation of presumption of conformity of the superseded standard shall be 30/06/2017.

CEN

EN ISO 15223-1:2016 (new)

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)

28/04/2005 

 

 

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 

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 

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 

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 

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 

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 

 

 

CEN

EN ISO 23640:2015

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

13/05/2016 

EN 13640:2002

Note 2.1 

30/06/2017 

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

 

18/01/2011 

 

 

Cenelec

EN 62366:2008

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

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 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.

Share

Share