• ANSI/AAMI ST8:2013(R2018)

    Current The latest, up-to-date edition.

    HOSPITAL STEAM STERILIZERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  17-08-2018

    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
    Foreword
    1 Scope
    2 Normative references
    3 Definitions, symbols, and abbreviations
    4 Requirements
    5 Tests
    Annexes
    A - Rationale for the development and provisions
        of this standard
    B - Examples of cycle documentation
    C - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (2 cubic feet [ft[3]]).

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

    Committee WG 43
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    CSA Z314.7 : 2003(R2018) STEAM STERILIZERS FOR HEALTH CARE FACILITIES
    CSA Z314.7 : 2003 : R2013 STEAM STERILIZERS FOR HEALTH CARE FACILITIES
    CSA Z314.7 : 2003 STEAM STERILIZERS FOR HEALTH CARE FACILITIES
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE 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 ST65 : 2008 : R2013 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
    AAMI ST65 : 2008 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ANSI/AAMI ST58:2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS

    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
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    AAMI ST42 : 2ED 98 STEAM STERILIZATION AND STERILITY ASSURANCE USING TABLE-TOP STERILIZERS IN OFFICE-BASED, AMBULATORY-CARE, MEDICAL, SURGICAL AND DENTAL FACILITIES
    ADA 59 : 1992 PORTABLE STEAM STERILIZERS FOR USE IN DENTISTRY
    ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS
    AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
    NFPA 70 : 2017 NATIONAL ELECTRICAL CODE
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
    ASME PV CODE SET : 2017 BOILER AND PRESSURE VESSEL CODE - COMPLETE SET
    AAMI TIR13 : 1ED 97 PRINCIPLES OF INDUSTRIAL MOIST HEAT STERILIZATION
    ANSI/AAMI/ISO 11138-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
    AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
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