• 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    Add to Watchlist
    This Standard has been added successfully to your Watchlist.
    Please visit My Watchlist to see all standards that you are watching.
    Please log in or to add this standard to your Watchlist.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    You have already added this standard to your Watchlist.
    Visit My Watchlist to view the full list.

    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    Superseded date:  01-15-2022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

    Add to Watchlist

    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.

    Add To Cart

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

    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

    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.

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

    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    Status Superseded
    Superseded By
    • Access your standards online with a subscription


      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective