Reference number
ISO 11138-2:2017
© ISO 2025
International Standard
ISO 11138-2:2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
Edition 3
2017-03
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Published (Edition 3, 2017)
This publication was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO 11138-2:2017

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CHF 43
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2017-03
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 3
    Number of pages
     : 6
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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