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  • ANSI/AAMI ST58:2013(R2018)

    Current The latest, up-to-date edition.

    CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  09-09-2018

    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
    Acknowledgments
    Foreword
    1 Scope
    2 Definitions and abbreviations
    3 Work area design considerations
    4 Personnel considerations
    5 Selection of liquid and gaseous chemical sterilants
    6 Decontamination and preparation of instruments
    7 Using chemical sterilants safely and effectively
    8 Device storage and transport
    9 Quality control
    10 Quality process improvement
    Annexes
    A - Microbial lethality, materials compatibility, and toxicity
    B - Glutaraldehyde solutions
    C - Hydrogen peroxide solutions
    D - Ortho-phthalaldehyde solutions
    E - Peracetic acid-hydrogen peroxide solutions
    F - Sodium hypochlorite solutions
    G - Chemical vapor sterilants using alcohol and formaldehyde
    H - Hydrogen peroxide gas plasma sterilization
    I - Ozone sterilization
    J - Government regulation
    K - Occupational exposure to bloodborne pathogens (29 CFR 1910.
        1030)
    L - User verification of cleaning processes
    M - Example of documentation of premature release of implants
    N - Gas and vapor monitoring
    O - Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other health care facilities.

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

    Committee WG 61
    Development Note Supersedes AAMI TIR7 (03/2006)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    AAMI TIR55 : 2014 HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES
    CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    AAMI TIR67 : 2018 PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES
    AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
    ANSI/AAMI ST90:2017 PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES
    AAMI TIR63 : 2014 MANAGEMENT OF LOANED CRITICAL AND SEMI-CRITICAL MEDICAL DEVICES THAT REQUIRE STERILIZATION OR HIGH-LEVEL DISINFECTION
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ASHRAE/ASHE 189.3 : 2017 DESIGN, CONSTRUCTION, AND OPERATION OF SUSTAINABLE HIGH-PERFORMANCE HEALTH CARE FACILITIES

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

    AIHA Z9.5 : 2012 LABORATORY VENTILATION
    AAMI TIR7 : 2ED 99 CHEMICAL STERILANTS AND HIGH LEVEL DISINFECTANTS: A GUIDE TO SELECTION AND USE
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
    CFR 49(PTS100-177) : OCT 2017 TRANSPORTATION
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    AAMI ST24:1999(R2018) AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    ANSI/AAMI/ISO 11138-1:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    ANSI Z358.1 : 2014 EMERGENCY EYEWASH AND SHOWER EQUIPMENT
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
    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.
    AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
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