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  • NF EN ISO 11138-2 : 2017

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES

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    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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    Abstract - (Show below) - (Hide below)

    Defines the requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 degrees C to 65 degrees C.

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    Development Note Indice de classement: S98-004-2. PR NF EN ISO 11138-2 October 2004. (10/2004) Supersedes NF EN 866-2 and NF EN 866-8. (11/2006) PR NF EN ISO 11138-2 February 2009. (02/2009)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Current

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

    NF EN ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    NF CEN ISO/TS 11135-2 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
    NF EN ISO 18472 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
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