CAN/CSA-ISO 11138-5:17 (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 low-temperature steam and formaldehyde
Annex B (informative) - Rationale for the liquid-phase test
        method for low-temperature steam and formaldehyde
        biological indicators
Bibliography

This is the first edition of CAN/CSA-ISO 11138-5, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-5 (second edition, 2017-03). 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 low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

CSA Preface This is the first edition of CAN/CSA-ISO 11138-5, Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes , which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-5 (second edition, 2017-03). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11138-5” 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 low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.