• AAMI/IEC TIR80001-2-8:2016

    Current The latest, up-to-date edition.

    APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC 80001-2-2

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-12-2016

    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
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Guidance for establishing
      SECURITY CAPABILITIES
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance to Health Delivery Organizations (HDOs) and MEDICAL DEVICE manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2.

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

    Committee 62
    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 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
    NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
    IEC TS 62443-1-1:2009 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
    ISO/IEC 15408-3:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 3: Security assurance components
    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 TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002
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