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  • BS EN 13640:2002

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Stability testing of in vitro diagnostic reagents

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  30-06-2012

    Language(s):  English

    Published date:  03-05-2002

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Applies to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents.

    General Product Information - (Show below) - (Hide below)

    Committee CH/212
    Development Note Supersedes 99/564178 DC (05/2002)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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