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    • CSA ISO 14971:21

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    CSA ISO 14971:21

    Medical devices – Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)

    SKU: 2701607 Published by CSA Group Publication Year 2021

    Product Details

    • Preface/Scope
    • Items Included

    CSA Preface


    This is the third edition of CSA ISO 14971, Medical devices – Application of risk management to medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14971 (third edition, 2019-12). It supersedes the previous edition, published in 2007 as CAN/CSA-ISO 14971 (adopted ISO 14971:2007).


    CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).


    This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


    Scope


    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. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.


    The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.


    The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.


    This document does not apply to:


    — decisions on the use of a medical device in the context of any particular clinical procedure; or


    — business risk management.


    This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.


    Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.


    NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

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    CSA ISO 14971:21

    Medical devices – Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)

    Active
    English

    CSA ISO 14971:F21

    Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux (norme ISO 14971:2019 adoptée, troisième édition, 2019-12)

    Active
    French

    CAN/CSA-ISO 14971-07 (R2017)

    Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

    Withdrawn
    English

    CAN/CSA-ISO 14971-F07 (C2017)

    Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (norme ISO 14971:2007 adoptée, deuxième édition, 2007-03-01)

    Withdrawn
    French

    CAN/CSA-ISO 14971-01 (R2006)

    Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)

    Withdrawn
    English

    CAN/CSA-ISO 14971-F01 (C2006)

    Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (norme ISO 14971:2000 adoptée, première édition, 2000-12-15)

    Withdrawn
    French

    CAN/CSA-ISO 14971-1-99

    Medical Devices - Risk Management - Part 1: Application of Risk Analysis (Adopted ISO 14971-1:1998, first edition)

    Withdrawn
    English
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