NF EN 13641 : 2002
Current
The latest, up-to-date edition.
ELIMINATION OR REDUCTION OF RISK OF INFECTION RELATED TO IN VITRO DIAGNOSTIC REAGENTS
12-01-2013
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.
| DevelopmentNote |
Indice de Classement: S92-041. Supersedes NFS 92 041 (03/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Current
|
| Supersedes |
| 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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