CSA Z15882:09 (R2019)

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General considerations
4 Classes of chemical indicator
5 Selection of chemical indicators
6 Use of chemical indicators
7 Interpretation of results from chemical indicators
8 Chemical indicators in sterility assurance procedures
9 Personnel training
10 Storage and handling
11 Labelling
Annex A (informative) - Background on the Bowie and Dick
        test
Annex B (informative) - Explanation of the terms 'parameter'
        and 'variable'
Annex C (informative) - Rationale for the requirements for
        integrating indicators and the link to the requirements
        for biological indicators (BIs) specified in the ISO
        11138 series and microbial inactivation (derived
        from ISO 11140-1)
Annex D (informative) - Specifications for porosity
Annex E (informative) - Figure showing relationship of
        indicator components
Bibliography

CSA Preface This is the second edition of CAN/CSA-Z15882, Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15882 (second edition, 2008-09-01). This standard supersedes the previous edition published in 2004 as CAN/CSA-Z15882 (adopted ISO 15882:2003). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope 1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).

CSA Preface This is the second edition of CAN/CSA-Z15882, Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15882 (second edition, 2008-09-01). This standard supersedes the previous edition published in 2004 as CAN/CSA-Z15882 (adopted ISO 15882:2003). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope 1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).