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NS EN 13640 : 1ED 2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STABILITY TESTING OF IN VITRO DIAGNOSTIC REAGENTS
Superseded date

01-03-2012

Published date

12-01-2013

Foreword
1 Scope
2 Terms and definitions
3 General requirements
4 Procedures
Annex A (informative) Procedure for predicting the
         shelf-life from accelerated stability testing
         based on the Arrhenius equation
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Applies to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded

Standards Relationship
EN 13640:2002 Identical
UNE-EN 13640:2002 Identical
BS EN 13640:2002 Identical
DIN EN 13640:2002-06 Identical
I.S. EN 13640:2002 Identical

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