Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN
Supersedes	CSA Z11137-3 : 2007 CSA Z11137-3 : 2007 CSA Z11137-3 : 2007 : R2012 CSA Z11137-3 : 2007 : R2012 : FR CSA Z11137-3 : 2007 : R2016