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  • ONORM EN ISO 11737-2 : 2010

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    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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    Withdrawn date:  15-06-2020

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    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian 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.

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    Committee TC 215
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ONORM EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

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

    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
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