CSA ISO 11137-2:16 (R2021)

CSA Preface

This is the second edition of CAN/CSA-ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-2 (third edition, 2013-06-01). It supersedes the previous edition published in 2007 as CAN/CSA-Z11137-2 (adopted ISO 11137-2:2006). For brevity, this Standard will be referred to as CAN/CSA-ISO 11137-2 throughout.

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 part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.