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SSH EN 13532:2005

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

Apr 1, 2005

General information

60.60     Apr 1, 2005

DPS

DPS/KT 206

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

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC

Life cycle

NOW

PUBLISHED
SSH EN 13532:2005
60.60 Standard published
Apr 1, 2005

Related project

Adopted from EN 13532:2002