• EN 80001-1:2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

    Available format(s): 

    Superseded date:  08-11-2021


    Published date:  18-03-2011

    Publisher:  European Committee for Standards - Electrical

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

    1 Scope
    2 Terms and definitions
    3 Roles and responsibilities
    5 Document control
    Annex A (informative) - Rationale
    Annex B (informative) - Overview of RISK MANAGEMENT
    Annex C (informative) - Guidance on field of application
    Annex D (informative) - Relationship with ISO/IEC 20000-2:2005
            Information technology - Service management - Part 2:
            Code of practice

    Abstract - (Show below) - (Hide below)

    IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 16484-2:2004 Building automation and control systems (BACS) — Part 2: Hardware
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 31000:2009 Risk management Principles and guidelines
    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 15026-2:2011 Systems and software engineering — Systems and software assurance — Part 2: Assurance case
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    IEC 61907:2009 Communication network dependability engineering
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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