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SRPS EN 13532:2008

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

Oct 9, 2008
95.99   Withdrawal of Standard   Oct 31, 2014

General information

95.99     Oct 31, 2014

ISS

Z076

European Norm

11.100  

English  

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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

NOW

WITHDRAWN
SRPS EN 13532:2008
95.99 Withdrawal of Standard
Oct 31, 2014

REVISED BY

PUBLISHED
SRPS EN 13532:2014

Related project

Adopted from EN 13532:2002