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SRPS EN 13532:2014

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

Oct 31, 2014
Oct 31, 2014

General information

90.60     Sep 2, 2025

ISS

Z076

European Norm

11.100  

Serbian  

From plan 2013

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Published

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Scope

This 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 13532:2008

NOW

PUBLISHED
SRPS EN 13532:2014
90.60 Close of review
Sep 2, 2025

Related project

Adopted from EN 13532:2002