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ISO 14971:2019

ISO 14971:2019

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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

Publisher

International Organization for Standardization

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$418.26
Including GST where applicable
Summarise this standard

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].

Committee
ISO/TC 210
DocumentType
Standard
Pages
39
ProductNote
THIS STANDARD ALSO REFERS TO IEC/TR 60513
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Frequently Asked Questions

ISO 14971 is used by medical device manufacturers and developers managing product safety risk throughout the lifecycle. It is an international standard published by International Organization for Standardization (ISO).

ISO 14971 is International Organization for Standardization (ISO)'s standard for medical device risk management, while S.R. CEN ISO/TR 24971 covers medical device risk management (Requires verification). ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. S.R. CEN ISO/TR 24971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It supports consistent specification, verification and documented acceptance across the relevant lifecycle.

ISO 14971 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. In practice it is applied by medical device manufacturers and developers managing product safety risk throughout the lifecycle.

ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It is an international standard published by International Organization for Standardization (ISO).
$418.26
Including GST where applicable
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Hardcopy - French
PDF 1 User - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - Spanish
PDF 1 User - Spanish
PDF 3 Users - Spanish
PDF 5 Users - Spanish
PDF 9 Users - Spanish
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