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EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing EN 13532:2002

Publication date:   Jan 22, 2004

General information

90.93 Standard confirmed   Feb 20, 2020

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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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 legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC

Life cycle

NOW

PUBLISHED
EN 13532:2002
90.93 Standard confirmed
Feb 20, 2020