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  • AAMI/IEC TIR80001-2-3:2012

    Current The latest, up-to-date edition.

    APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  02-09-2012

    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 80001-2-3:2012
    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.

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

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

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

    AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS

    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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