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  • BS EN 12297:1998

    Current The latest, up-to-date edition.

    Biotechnology. Equipment. Guidance on testing procedures for sterilizability

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-09-1998

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Definitions
    3 Testing
    4 Documentation
    Annex A (informative) Guidance on selection of
    sterilizability testing
    Annex B (informative) Information on test methods for
    sterilizability
    Annex C (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Provides guidance on general test methods for assessment of the sterilizability for micro-organisms of equipment (components and units of equipment) for biotechnological processes. Applies to plants or components, eg valves and fittings, tanks, pumps, piping separating and filling devices, in addition to instrumentation in contact with process fluids.

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

    Committee BTI/1
    Development Note Supersedes 96/121001 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
    NFX 42 101 : 1987 BIOTECHNOLOGIES - PROCEDURE A SUIVRE EN VUE DE TESTER L'APTITUDE D'UNE INSTALLATION DE FERMENTATION A FONCTIONNER SOUS CONDITIONS DE STERILITE
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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