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  • AAMI IEC TIR 80001-2-2 : 2012

    Current The latest, up-to-date edition.

    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

    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 80001-2-2:2012
    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Use of SECURITY CAPABILITIES
    5 SECURITY CAPABILITIES
    6 Example of detailed specification under SECURITY
      CAPABILITY: Person authentication - PAUT
    7 References
    8 Other resources
    9 Standards and frameworks
    Annex A (informative) - Sample scenario showing
            the exchange of security information
    Annex B (informative) - Examples of regional
            specification on a few SECURITY CAPABILITIES
    Annex C (informative) - SECURITY CAPABILITY
            mapping to C-I-A-A
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection.

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

    Committee WG 02
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    AAMI TIR57 : 2016 PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
    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/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
    ISO/IEC 15408-3:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 3: Security assurance components
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
    NEN 7510 : 2011 HEALTH INFORMATICS - INFORMATION SECURITY MANAGEMENT IN HEALTHCARE
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    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 20000-1:2011 Information technology Service management Part 1: Service management system requirements
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
    ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
    ISO/TS 13606-4:2009 Health informatics Electronic health record communication Part 4: Security
    IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
    IEC 61907:2009 Communication network dependability engineering
    ISO/IEC 15408-1:2009 Information technology — Security techniques — Evaluation criteria for IT security — Part 1: Introduction and general model
    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
    ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
    ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002
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