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Full Description

This guideline provides the essential elements for the use of biological indicators (BIs) to develop and monitor industrial steam and ethylene oxide (EO) sterilization processes. This guideline addresses sterilization equipment, BI selection, appropriate use of BIs for qualification/validation, routine monitoring, and revalidation of sterilization processes.
 

Document History

  1. AAMI/ISO 11138-7:2019


    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results

    • Most Recent
  2. AAMI/ISO 14161:2009/(R)2014


    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results

    • Historical Version
  3. AAMI/ISO 14161:2000


    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results

    • Historical Version
  4. AAMI ST34-91

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    Guideline for the Use of Ethylene Oxide and Steam Biological Indicators in Industrial Sterilization Processes

    • Historical Version