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  • ONORM EN ISO 18472 : 2006

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT

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    Withdrawn date:  22-11-2018

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements for resistometers
      4.1 Intended use
      4.2 Measurement and control capabilities
      4.3 Test methods
      4.4 Leak test
      4.5 Steam resistometer performance requirements
      4.6 Ethylene oxide resistometer performance requirements
      4.7 Dry heat (heated air) resistometer performance
          requirements
      4.8 Vaporized hydrogen peroxide process resistometer
          performance requirements
    5 Recording systems
      5.1 Measurement systems
      5.2 Calibration
    6 Documentation
      6.1 General
      6.2 Minimum information
    Annex A (informative) Additional performance characterization
            - Steam
    Annex B (informative) Additional performance characterization
            - Ethylene oxide
    Annex C (informative) Additional performance characterization
            - Dry heat
    Annex D (informative) Resistometer documentation and derivations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators.

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

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    Status Withdrawn
    Superseded By

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

    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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