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ISO 14971:2019

Current

Current

The latest, up-to-date edition.

Medical devices Application of risk management to medical devices

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English, Spanish, Castilian

Published date

10-12-2019

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].

DocumentType
Standard
Pages
39
ProductNote
THIS STANDARD ALSO REFERS TO IEC/TR 60513
PublisherName
International Organization for Standardization
Status
Current
Supersedes

AAMI TIR52:2014(R2022) Environmental monitoring for terminally sterilized healthcare products
ANSI/AAMI/ISO 10993-13:2010(R2019) Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
ANSI/AAMI/ISO 10993-16:2020(R2022) Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

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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