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  • IEC TR 80001-2-5:2014

    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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  16-12-2014

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    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)

    IEC TR 80001-2-5:2014(E) which is a technical report, gives 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. This technical report applies to the transmission of alarm conditions between sources, integrator and communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.

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

    Development Note Stability date: 2018. (12/2014)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Current

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

    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

    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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