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EN 13532:2002 Standard

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  Keywords:

#ivd #mds #specified #suitable #purposes

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

General requirements for in vitro diagnostic medical devices for self-testing

  Purpose

This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

  Publication

Friday 17th of November 2017

  Related Standards

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Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 23640:2015

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

EN ISO 20776-1:2006

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Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of p...

EN ISO 18113-5:2011

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

EN ISO 18113-4:2011

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents ...

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