CAN/CSA-ISO 11138-2:17 (R2022)

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). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11138-2” throughout.  This Standard was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and the CSA Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee.  This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 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.