I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STABILITY TESTING OF IN VITRO DIAGNOSTIC REAGENTS
Hardcopy , PDF
20-12-2011
English
01-01-2002
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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.
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 13640 : 2002 | Identical |
| BS EN 13640:2002 | Identical |
| NS EN 13640 : 1ED 2002 | Identical |
| UNE-EN 13640:2002 | Identical |
| DIN EN 13640:2002-06 | Identical |
| SN EN 13640 : 2002 | Identical |
| NEN EN 13640 : 2002 | Identical |
| EN 13640:2002 | Identical |
| UNI EN 13640 : 2002 | Identical |
| NBN EN 13640 : 2002 | Identical |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
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