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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 13485:2016/AC:2018

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

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

EN 14136:2004

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

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN ISO 18113-2:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

EN ISO 18113-1:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and genera...

EN ISO 15223-1:2016

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

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

EN ISO 14971:2012

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

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

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