• I.S. EN ISO 14971:2019

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical devices - Application of risk management to medical devices (ISO 14971:2019)

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-15-2022

    Language(s):  English

    Published date:  01-06-2020

    Publisher:  National Standards Authority of Ireland

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    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for risk management system
    5 Risk analysis
    6 Risk evaluation
    7 Risk control
    8 Evaluation of overall residual risk
    9 Risk management review
    10 Production and post-production activities
    Annex A (informative) Rationale for requirements
    Annex B (informative) Risk management process for medical devices
    Annex C (informative) Fundamental risk concepts
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

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    Committee TC 210
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS:IEC/TR 60513
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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