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SSH EN 376:1998

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

Jan 1, 1998

General information

60.60     Jan 1, 1998

DPS

DPS/KT 76

European Norm

11.100  

English  

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Scope

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents.

NOTE This standard can also be applied to accessories.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
more

Life cycle

NOW

PUBLISHED
SSH EN 376:1998
60.60 Standard published
Jan 1, 1998

Related project

Adopted from EN 376:2002

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