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I.S. EN 13640:2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

20-12-2011

Language(s)

English

Published date

01-01-2002

Preview

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.

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Superseded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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