Name: CSA Z15882 :2009
Brand: CSA

CSA Z15882 :2009

Superseded

View Superseded by

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS

Available format(s)

Hardcopy , PDF

Superseded date

10-12-2020

Language(s)

French

Published date

01-01-2014

Publisher

Canadian Standards Association

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

Specifies 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.

DevelopmentNote	French Edition issued on 01-12-2014. (01/2015)
DocumentType	Standard
Pages	52
ProductNote	Reconfirmed F
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA Z15882 : 2009 : R2014
Supersedes	CSA Z15882 : 2004

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