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Norm

ISO 14971:2019

Issue date: 2019 12 10

Medical devices — Application of risk management to medical devices

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medic...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 36 Pages
Language:
English

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].

ISO 14971:2019
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ISO 14971:2007
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 14971:2000/Amd 1:2003
2003 02 19
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for req...
Norm
ISO 14971:2000
2000 11 30
Medical devices — Application of risk management to medical devices
Norm
ISO 14971-1:1998
1998 10 01
Medical devices — Risk management — Part 1: Application of risk analysis
Norm
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