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NEN EN 13641 : 2002

Current

Current

The latest, up-to-date edition.

ELIMINATION OR REDUCTION OF RISK OF INFECTION RELATED TO IN VITRO DIAGNOSTIC REAGENTS

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements related to design and manufacture
5 Information supplied by the manufacturer
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Defines requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It applies to in vitro diagnostic reagents containing material of human origin.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
EN 13641:2002 Identical
UNI EN 13641 : 2003 Identical
BS EN 13641:2002 Identical
DIN EN 13641:2002-08 Identical
UNE-EN 13641:2002 Identical

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