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Full Description

Details additional, specific requirements for biological indicators intended for use in assessing the performance of sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases at sterilizing temperatures within the range of 20degC to 65degC. This standard replaces the previous standard for biological indicators for use with ethylene oxide sterilizers ANSI/AAMI ST21:1986/(R)1994.
 

Document History

  1. AAMI/ISO 11138-2:2017/(R)2024


    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    • Most Recent
  2. AAMI/ISO 11138-2:2006/(R)2015


    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

    • Historical Version
  3. AAMI ST21-99

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    Biological Indicators for Ethylene Oxide Sterilization Processes in Health Care Facilities

    • Historical Version