DIN EN 13640:2002-06
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STABILITY TESTING OF IN VITRO DIAGNOSTIC REAGENT
01-03-2012
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
This standard is included in DIN Handbook 378. 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 |
German Institute for Standardisation (Deutsches Institut für Normung)
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
NBN EN 13640 : 2002 | Identical |
NF EN 13640 : 2002 | Identical |
BS EN 13640:2002 | Identical |
NS EN 13640 : 1ED 2002 | Identical |
SN EN 13640 : 2002 | Identical |
UNE-EN 13640:2002 | Identical |
NEN EN 13640 : 2002 | Identical |
I.S. EN 13640:2002 | Identical |
UNI EN 13640 : 2002 | Identical |
EN 13640:2002 | Identical |
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