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  • 15/30321502 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-04-2017

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    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

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

    Comment Closes On
    Committee CH/198
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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 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 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    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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