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  • BS EN ISO 11138-5:2017

    Current The latest, up-to-date edition.

    Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde 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 low-temperature steam and formaldehyde as the sterilizing agent.

    NOTE1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO14937 .

    NOTE2 Requirements for work place safety can be provided by national or regional regulations.

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    Committee CH/198
    Development Note Supersedes BS EN 866-5 and 04/30078111 DC (08/2006) Supersedes 15/30321514 DC. (04/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    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
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