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  • CSA Z17665-2:09 (R2019)

    Current The latest, up-to-date edition.

    Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)

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    Published date:  01-01-2019

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system elements
    5 Sterilizing agent characterization
    6 Process and equipment characterization
    7 Product definition
    8 Process definition
    9 Validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness
    Annex A (informative) - Evaluation of a sterilization
            process primarily based on the measurement
            of physical parameters
    Annex B (informative) - Evaluation of a sterilization
            process primarily based on biological inactivation
            and an accompanying mechanical air removal procedure
    Annex C (informative) - Temperature and pressure of
            saturated steam for use in moist heat sterilization
    Annex D (informative) - Special considerations for health
            care settings
    Annex E (informative) - Index of normative clauses/subclauses
            of ISO 17665-1 and cited references or related
            guidance given in ISO 17665-1 and ISO/TS 17665-2
    Bibliography

    Abstract - (Show below) - (Hide below)

    This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1.

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

    Committee TC 198
    Document Type Revision
    Product Note Reconfirmed EN THIS STANDARD ALSO REFERS TO ISO 15883-5,
    Publisher Canadian Standards Association
    Status Current
    Supersedes

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

    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    BS EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    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 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    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/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
    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
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 13060:2014 Small steam sterilizers
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