CSA Preface This is the first edition of CAN/CSA-ISO 11138-2, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-2 (third edition, 2017-03).
Scope This document 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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