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  • ANSI/AAMI/ISO 11138-1:2017

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-08-2017

    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 11138-1:2017
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General manufacturing requirements
    5 Specific manufacturing requirements
    6 Determination of population and 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)

    Describes 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)

    Development Note Supersedes AAMI ST59. (05/2006)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    ANSI/AAMI ST58:2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    AAMI TIR39:2009 GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES
    AAMI TIR39:2009(R2017) GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
    AAMI TIR16:2023 Microbiological aspects of ethylene oxide sterilization

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

    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 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 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 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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