OS GSO ISO 11138-2:2021
ISO 11138-2:2017
Omani Standard
Current Edition
·
Approved on
01 July 2021
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
OS GSO ISO 11138-2:2021 Files
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OS GSO ISO 11138-2:2021 Scope
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.
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