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  • ANSI/AAMI/IEC TIR80001-2-1:2012

    Current The latest, up-to-date edition.

    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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-09-2012

    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 80001-2-1:2012
    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Prerequisites
    5 Study of terms used in RISK MANAGEMENT
    6 The steps
    7 IEC 80001-1:2010, Subclause 4.4: Step by step
    8 Practical examples
    Annex A (informative) - Common HAZARDS, HAZARDOUS SITUATIONS,
            and causes to consider in MEDICAL IT-NETWORKS
    Annex B (informative) - List of questions to consider
            when identifying HAZARDs of the MEDICAL IT-NETWORK
    Annex C (informative) - Layers of MEDICAL IT-NETWORKS
            where errors can be found
    Annex D (informative) - Probability, severity, and RISK
            acceptability scales used in the examples in this
            technical report
    Annex E (informative) - MONITORING RISK mitigation
            effectiveness
    Annex F (informative) - RISK ANALYZING small changes
            in a MEDICAL IT-NETWORK
    Annex G (informative) - Example of Change Window Form
    Annex H (informative) - Template for examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies step-by-step information to aid RESPONSIBLE ORGANIZATIONS in implementation of the RISK MANAGEMENT PROCESS required by IEC 80001-1.

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

    Committee IT
    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
    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO/TS 19218-2:2012 Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes
    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
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002
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