CAN/CSA-ISO 11138-3:17 (R2022)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
        resistance to moist heat sterilization
Annex B (normative) - Calculation of z value and
        coefficient of determination, r[2]
Bibliography

Defines requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

CSA Preface This is the first edition of CAN/CSA-ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-3 (third edition, 2017-03). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11138-3” 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 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.