• I.S. EN IEC 80001-1:2021

    Current The latest, up-to-date edition.

    Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-11-2021

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles
    5 Framework
    6 RISK MANAGEMENT PROCESS
    Annex A (informative) IEC 80001-1 requirements mapping table
    Annex B (informative) Guidance for accompanying document Information
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.

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

    Committee SC 62A
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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