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  • NBN EN ISO 11737-2 : 2010

    Current The latest, up-to-date edition.

    STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

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    Published date:  12-01-2013

    Publisher:  Belgian Standards

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General
    5 Selection and preparation of product units for
          testing
    6 Tests of sterility
    7 Assessment of method for test of sterility
    Annex A (informative) Guidance on tests of sterility
                          performed in validation of a
                          sterilization process
    Bibliography

    Abstract - (Show below) - (Hide below)

    Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.

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

    Document Type Standard
    Publisher Belgian Standards
    Status Current
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