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UNI EN 13641 : 2003

Current

Current

The latest, up-to-date edition.

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

Published date

05-01-2003

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.

Committee
CT 44
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current

Standards Relationship
NS EN 13641 : 1ED 2002 Identical
NBN EN 13641 : 2002 Identical
BS EN 13641:2002 Identical
SN EN 13641 : 2002 Identical
UNE-EN 13641:2002 Identical
DIN EN 13641:2002-08 Identical
NEN EN 13641 : 2002 Identical
I.S. EN 13641:2002 Identical
NF EN 13641 : 2002 Identical
EN 13641:2002 Identical

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