• BS EN ISO 11138-3:2017

    Current The latest, up-to-date edition.

    Sterilization of health care products. Biological indicators Biological indicators for moist heat sterilization processes

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-04-2017

    Publisher:  British Standards Institution

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    This document 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.

    NOTE1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO17665 series.

    NOTE2 National or regional regulations can provide requirements for work place safety.

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    Committee CH/198
    Development Note Supersedes BS EN 866-3, BS EN 866-7 and 04/30078103 DC (08/2006) Supersedes 15/30321508 DC. (04/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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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