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UNE-EN 13641:2002

Current

Current

The latest, up-to-date edition.

Elimination or reduction of risk of infection related to in vitro diagnostic reagents.

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

29-10-2002

€58.80
Excluding VAT

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.

Committee
CTN 129
DocumentType
Standard
Pages
12
PublisherName
Asociacion Espanola de Normalizacion
Status
Current

Standards Relationship
NF EN 13641 : 2002 Identical
NBN EN 13641 : 2002 Identical
NEN EN 13641 : 2002 Identical
NS EN 13641 : 1ED 2002 Identical
I.S. EN 13641:2002 Identical
SN EN 13641 : 2002 Identical
UNI EN 13641 : 2003 Identical
BS EN 13641:2002 Identical
EN 13641:2002 Identical
DIN EN 13641:2002-08 Identical

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