• ISO 14971:2019

    Current The latest, up-to-date edition.
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    Medical devices Application of risk management to medical devices

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English, Spanish, Castilian

    Published date:  12-10-2019

    Publisher:  International Organization for Standardization

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    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. 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].

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

    Committee ISO/TC 210
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO IEC/TR 60513
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
    SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
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