CAN/CSA-ISO 11138-1:17 (R2022)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth
        inhibition by carriers and primary packaging
        materials exposed to sterilization processes
Annex C (normative) - D value determination by
        survivor curve method
Annex D (normative) - D value determination by
        fraction negative method
Annex E (normative) - Survival-kill response
        characteristics
Annex F (informative) - Relationship between
        components of biological indicators
Bibliography

Defines general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

CSA Preface This is the second edition of CAN/CSA-ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements , which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-1 (third edition, 2017-03). It supersedes the previous edition published in 2007 as CAN/CSA-Z11138-1 (adopted ISO 11138-1:2006). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11138-1” 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 general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. This document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.