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

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).

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.

See more