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About This Item

 

Full Description

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.

NOTE 2 National or regional regulations can provide requirements for work place safety.

 

Document History

  1. ISO 11138-2:2017

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

    • Most Recent
  2. ISO 11138-2:2006


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

    • Historical Version
  3. ISO 11138-2:1994


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

    • Historical Version