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  • EN ISO 11138-3:2017

    Current The latest, up-to-date edition.

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)

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    Language(s): 

    Published date:  29-03-2017

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Test organism
    6 Suspension
    7 Carrier and primary packaging
    8 Inoculated carriers and biological indicators
    9 Population and resistance
    Annex A (normative) - Method for determination of
            resistance to moist heat sterilization
    Annex B (normative) - Calculation of z value and
            coefficient of determination, r[2]
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.NOTE 2 National or regional regulations can provide requirements for work place safety.

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

    Committee CEN/TC 102
    Development Note Supersedes EN 866-3 and EN 866-7. (08/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
    04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
    PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
    I.S. EN 13060:2014 SMALL STEAM STERILIZERS
    VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
    EN 13060:2014 Small steam sterilizers
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    UNE-EN 13060:2015 Small steam sterilizers
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS

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

    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    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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