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  • AAMI/ISO 13485:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  17-10-2019

    Language(s):  English

    Published date:  03-01-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Committee WG 01
    Development Note Supersedes AAMI ISO 13488 (06/2004)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
    AAMI TIR35 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
    AAMI TIR59:2017 INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    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 TIR26 : 2000 VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
    AAMI HE74 : 2001 HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
    AAMI ST63 : 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
    AAMI HE74 : 2001 : R2009 HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
    AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
    ANSI/AAMI ST90:2017 PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES
    ANSI/AAMI EQ89:2015 GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES
    AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    AAMI TIR56:2013(R2020) GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
    AAMI TIR56 : 2013 GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
    AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
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