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

10-29-2002

Publisher

Asociacion Espanola de Normalizacion

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