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About This Item

 

Full Description

BS EN 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.


Cross References:
ISO 11138-1:2017
ISO 18472
ISO 11135
ISO 14161
ISO 14937


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 11138-2:2017

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    Sterilization of health care products. Biological indicators-Biological indicators for ethylene oxide sterilization processes

    • Most Recent
  2. BS EN ISO 11138-2:2009


    Sterilization of health care products. Biological indicators-Biological indicators for ethylene oxide sterilization processes

    • Historical Version
  3. BS EN ISO 11138-2:2006


    Sterilization of health care products. Biological indicators-Biological indicators for ethylene oxide sterilization processes

    • Historical Version
  4. BS EN 866-8:2000


    Biological systems for testing sterilizers and sterilization processes-Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers

    • Historical Version
  5. BS EN 866-2:1998


    Biological systems for testing sterilizers and sterilization processes-Particular systems for use in ethylene oxide sterilizers

    • Historical Version