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  • CSA Z11138-1 : 2007 : R2012 : FR

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-08-2017

    Language(s):  English

    Published date:  01-01-2016

    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 General manufacturing requirements
    5 Specific manufacturing requirements
    6 Determination of resistance
    7 Culture conditions
    Annex A (normative) - Determination of viable count
    Annex B (normative) - Determination of growth inhibition
            by carriers and primary packaging materials
            exposed to sterilization processes
    Annex C (normative) - D value determination by survivor
            curve method
    Annex D (normative) - D value determination by fraction
            negative method
    Annex E (normative) - Survival-kill response characteristics
    Annex F (informative) - Relationship between components
            of biological indicators
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

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

    Document Type Standard
    Product Note Reconfirmed F
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    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 10241:1992 International terminology standards Preparation and layout
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    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
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    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
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    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 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
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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