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EN 375:2001

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use EN 375:2001

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Dec 15, 2009

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

01.040.11   Health care technology (Vocabularies) | 11.100   Laboratory medicine

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Language in which you want to receive the document.

Scope

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 375:1992

NOW

WITHDRAWN
EN 375:2001
99.60 Withdrawal effective
Dec 15, 2009

REVISED BY

WITHDRAWN
EN ISO 18113-2:2009