Preface:

This is the first edition of CSA ISO/TS 11137-4, Sterilization of health care products — Radiation — Part 4: Guidance on process control, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 11137-4 (first edition, 2020-06). At the time of publication, ISO/TS 11137-4:2020 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO.

CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).

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 provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.