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CSA Z15882:09 (R2019)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)

Available format(s)

Hardcopy , PDF

Superseded date

10-12-2020

Language(s)

English, English - French, French

Published date

01-01-2009

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).

DevelopmentNote
French Edition issued on 01-12-2014. (01/2015)
DocumentType
Standard
ISBN
9781554971448
Pages
0
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
Supersedes

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).

Standards Relationship
ISO 15882:2008 Identical

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
AAMI ST46 : 4ED 2002 STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 5636-5:2013 Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 9001:2015 Quality management systems — Requirements
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

US$163.00
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