BS EN 13640:2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Stability testing of in vitro diagnostic reagents
Hardcopy , PDF
06-30-2012
English
05-03-2002
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 99/564178 DC (05/2002)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN 13640 : 2002 | Identical |
| NF EN 13640 : 2002 | Identical |
| UNE-EN 13640:2002 | Identical |
| DIN EN 13640:2002-06 | Identical |
| I.S. EN 13640:2002 | Identical |
| NS EN 13640 : 1ED 2002 | Identical |
| SN EN 13640 : 2002 | Identical |
| NEN EN 13640 : 2002 | Identical |
| EN 13640:2002 | Identical |
| UNI EN 13640 : 2002 | Identical |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
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