CAN/CSA-ISO 11137-3:17 (R2022)

CSA Preface

This is the second edition of CAN/CSA-ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-3 (second edition, 2017-06). It supersedes the previous edition published in 2007 as CAN/CSA-Z11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects (adopted ISO 11137-3:2006).

For brevity, this Standard will be referred to as “CAN/CSA-ISO 11137-3” 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 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.