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  • IEC TR 80001-2-1:2012

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  05-04-2024

    Language(s):  English

    Published date:  10-07-2012

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    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, Clause 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)

    IEC/TR 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

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

    Committee TC 62/SC 62A
    Development Note Stability date: 2017. (09/2017)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    Status Withdrawn

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

    16/30346073 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    EN 62453-1:2017 Field Device Tool (FDT) interface specification - Part 1: Overview and guidance
    PD ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices. Application guidance Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
    PD IEC/TR 80001-2-9:2017 Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
    AAMI IEC TIR 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
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    I.S. EN 62453-1:2017 FIELD DEVICE TOOL (FDT) INTERFACE SPECIFICATION - PART 1: OVERVIEW AND GUIDANCE
    AAMI/IEC TIR80001-2-5:2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
    NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN 62453-1:2017 Field Device Tool (FDT) interface specification Overview and guidance
    PD IEC/TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices Application guidance. General implementation guidance for healthcare delivery organizations
    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
    PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
    PD IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
    AAMI/IEC TIR80001-2-4:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-4: GENERAL IMPLEMENTATION GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS
    IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
    IEC 62453-1:2016 Field device tool (FDT) interface specification - Part 1: Overview and guidance
    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
    PD IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
    IEC TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
    AAMI/IEC TIR80001-2-7:2014 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
    ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    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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