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  • PLUS 1173 (1st ed. pub. 2012)

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Guide to the selection and use of sterilization indicators

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Canadian Standards Association

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

    Preface
    1 Effective sterilization processing
    2 Assessing sterilization effectiveness
    3 Determining the efficacy of a sterilization process
    4 Selecting a new sterilization indicator system
    5 Managing risk
    6 Evaluating the system
    7 Additional considerations
    8 Sensitivity of sterilization indicators
    9 Sterilization failures
    10 Summary
    11 References
    Annexes
    A - Verification and validation testing
    B - Implementing a new system
    C - Sterilization failures - Factors to consider
    D - Reference publications

    Abstract - (Show below) - (Hide below)

    Details about the effective sterilization process.

    Scope - (Show below) - (Hide below)

    Preface This is the first edition of CSA PLUS 1173, Guide to the selection and use of sterilization indicators. This handbook has been developed to answer general questions in all health care and personal service settings where monitoring of the effectiveness of reprocessing of medical devices takes place. Introduction Effective sterilization processing is critical to the successful outcome of the thousands of sterile procedures that are performed daily at health care institutions and clinics throughout North America. This requires that reusable surgical instruments and medical devices be effectively cleaned, inspected, packaged, labelled, sterilized, and transported for reprocessing following their use. Multiple steps are necessary to ensure that each patient receives instruments and supplies that have been processed to the highest standards of care. In order to ensure the delivery of instrumentation that is safe and effective for use, health care professionals should not only adhere to the recommendations of the instrument manufacturer and relevant processing guidelines, but need to also have an understanding of the technology (equipment and processes) used to reprocess surgical instruments and medical devices. This includes an understanding of the basis whereby a given sterilization load is deemed acceptable for use. A key factor in this determination is the results of testing performed with various types of sterilization indicators.

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    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded

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

    ISO 11138-3:2017 Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes
    ISO 15882:2008 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results
    CSA Z314.7 : 2003(R2018) STEAM STERILIZERS FOR 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
    ISO 11138-2:2017 Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
    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 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 11140-5:2007 Sterilization of health care products Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    ISO 11138-1:2017 Sterilization of health care products Biological indicators Part 1: General requirements
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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