• PD IEC/TR 80001-2-3:2012

    Current The latest, up-to-date edition.

    Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  10-07-2012

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope and object
    2 Normative references
    3 Terms and definitions
    4 Wireless MEDICAL IT-NETWORK: An introduction
    5 Wireless MEDICAL IT-NETWORKS: Planning and design
    6 Wireless MEDICAL IT-NETWORKS: Deployment and
      configuration
    7 Wireless MEDICAL IT-NETWORKS: Management and
      support
    8 General RISK CONTROL measures
    Annex A (informative) - Clinical use cases and
            network traffic profiles
    Annex B (informative) - Questions to consider
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives technical background concerning wireless technology and examples of HAZARDS to be considered when wireless technology is used in MEDICAL IT-NETWORKS and suggests RISK CONTROL measures to reduce the probability of UNINTENDED CONSEQUENCES.

    Scope - (Show below) - (Hide below)

    IEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network.

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

    Committee CH/62/1
    Document Type Standard
    Publisher British Standards Institution
    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
    ISO/IEC 15408-2:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 2: Security functional components
    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
    ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
    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
    AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
    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
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