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  • ANSI/AAMI/ISO 15882:2008(R2013)

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  04-10-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO 15882:2008
    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 General considerations
    4 Classes of chemical indicator
       4.1 General
       4.2 Class 1: Process indicators
       4.3 Class 2: Indicators for use in specific tests
       4.4 Class 3: Single variable indicators
       4.5 Class 4: Multi-variable indicators
       4.6 Class 5: Integrating indicators
       4.7 Class 6: Emulating indicators
    5 Selection of chemical indicators
    6 Use of chemical indicators
       6.1 Class 1 process indicators
       6.2 Class 2 indicators
       6.3 Class 3, 4, 5 and 6 indicators
       6.4 Indicators for use with process challenge devices
    7 Interpretation of results from chemical indicators
       7.1 General
       7.2 Chemical indicator responses
       7.3 Chemical indicators showing 'fail' response
    8 Chemical indicators in sterility assurance procedures
       8.1 General
       8.2 Record keeping
    9 Personnel training
    10 Storage and handling
    11 Labeling
       11.1 General
       11.2 Indicator marking
       11.3 Process marking
       11.4 Package marking
    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

    Abstract - (Show below) - (Hide below)

    Describes 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.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 198
    Development Note Supersedes AAMI TIR25 (02/2005)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    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
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