NEN EN 13640 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-12-2011
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 |
Netherlands Standards
|
| 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Superseded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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