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  • AAMI/IEC TIR80001-2-5:2014

    Current The latest, up-to-date edition.

    APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  24-12-2014

    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 IEC TR 80001-2-5
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Functions of the distribution of ALARM CONDITIONS
    5 Types of systems for distributing ALARM CONDITIONS
    6 RISK MANAGEMENT
    Annex A (informative) - Correspondence between the
            RISK CONTROL measures of this technical report
            and IEC 60601-1-8
    Annex B (informative) - Types of SOURCES
    ANNEX C (informative) - Applicability of types of
            system for the distribution of ALARM CONDITIONS
    Annex D (informative) - Scalability of types of system
            for the distribution of ALARM CONDITIONS
    Bibliography
    Index of defined terms used in this technical report

    Abstract - (Show below) - (Hide below)

    Provides guidance and practical techniques for RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the RISK MANAGEMENT of DISTRIBUTED ALARM SYSTEMS.

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

    Committee WG 02
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
    NFPA 72 : 2016 NATIONAL FIRE ALARM AND SIGNALING CODE
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    VDE 0834-1 : 2016 Call systems in hospitals, nursing homes and similiar institutions Part 1: Requirements for equipment, planning, erection and operation
    IEC TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
    VDE 0834-2 : 2000 CALL SYSTEMS IN HOSPITALS, NURSING HOMES AND SIMILAR INSTITUTIONS - ENVIRONMENTAL CONDITIONS AND ELECTROMAGNETIC COMPATIBILITY
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