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  • CEI EN 80001-1 : 2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-08-2022

    Language(s):  English - Italian

    Published date:  31-12-2015

    Publisher:  Comitato Elettrotecnico Italiano

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Terms and definitions
    3 Roles and responsibilities
    4 Life cycle RISK MANAGEMENT in MEDICAL
      IT-NETWORKS
    5 Document control
    Annex A (informative) - Rationale
    Annex B (informative) - Overview of RISK MANAGEMENT
            relationships
    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
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes 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).

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

    Committee CT 62
    Development Note Classificazione CEI 62-233. (02/2012)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Superseded
    Superseded By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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