Standard

NEN-EN-ISO 14971:2019 en

Medical devices - Application of risk management to medical devices

158,65 172,93 Incl BTW

About norm

Status Current
Number of pages 36
Committee Medische hulpmiddelen - horizontale onderwerpen
Published on 01-12-2019
Language English
NEN-EN-ISO 14971 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.

Details

ICS-code 11.040.01
Dutch title Medische hulpmiddelen - Toepassing van risicomanagement voor medische hulpmiddelen
English title Medical devices - Application of risk management to medical devices
Replaces

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