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

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Measurement of dose
5 Establishing the maximum acceptable dose
6 Establishing the sterilization dose
7 Installation qualification
8 Operational qualification
9 Performance qualification
10 Routine monitoring and control
Annex A (informative) - Mathematical modelling
Annex B (informative) - Tables of references for
        dosimetry-related testing during IQ/OQ/PQ30
Annex C (informative) - Tolerances associated with
        doses used in sterilization dose
        setting/substantiation in ISO 11137-2
        and ISO/TS 13004
Annex D (informative) - Application of dose
        measurement uncertainty in setting
        process target doses
Bibliography

Specifies 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.

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.