ISO DIS 14971

Medical devices - Application of risk management to medical devices

active, Most Current
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Organization: ISO
Publication Date: 19 July 2018
Status: active
Page Count: 51
ICS Code (Medical equipment in general): 11.040.01
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 (IVD) 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 stages of the life-cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as for example those related to biocompatibility, data and systems security, electricity, moving parts, radiation, usability, and other risks. This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure.

This document does also not apply to business risk management. This document does not specify acceptable risk levels, but requires manufacturers to establish objective criteria for risk acceptability.

This document does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

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

Document History

ISO DIS 14971
July 19, 2018
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 (IVD) medical devices. The process...
March 1, 2007
Medical devices - Application of risk management to medical devices
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and...
December 15, 2000
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...
December 15, 2000
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.

References

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