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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

Thursday 15th of April 2021

  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

EN ISO 23640:2015

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

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

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 13612:2002/AC:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN ISO 13485:2016/AC:2016

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

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

EN ISO 13485:2016

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

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

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