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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

Wednesday 25th of March 2020

  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

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

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