GSO ISO 11138-2:2021

ISO 11138-2:2017

Gulf Standard Current Edition · Approved on 01 July 2021

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

GSO ISO 11138-2:2021 Files

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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.