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  • AAMI/IEC TIR80001-2-7:2014

    Current The latest, up-to-date edition.

    APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1

    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 ISO TR 80001-2-7 Ed.1
    Foreword
    Introduction
    1 Scope
    2 Normative References
    3 Terms and Definitions
    4 Assessment Method
    Annex A (informative) - Assessment Method
    Annex B (informative) - Process Reference Model
    Annex C (informative) - Process Assessment Model
    Annex D (informative) - Abbreviations and Process
            Identifiers
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance to HDOs on self-assessment of their conformance against IEC 80001-1.

    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
    ISO/IEC TR 24774:2010 Systems and software engineering Life cycle management Guidelines for process description
    ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
    ISO/IEC TR 15504-6:2008 Information technology Process assessment Part 6: An exemplar system life cycle process assessment model
    ISO/IEC 15289:2006 Systems and software engineering Content of systems and software life cycle process information products (Documentation)
    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
    ISO/IEC 15504-2:2003 Information technology Process assessment Part 2: Performing an assessment
    ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
    ISO/IEC 15504-1:2004 Information technology Process assessment Part 1: Concepts and vocabulary
    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 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
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