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ISO 14971:2007

Medical devices -- Application of risk management to medical devices

General information

Withdrawn from 10.12.2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
10.12.2019
Main
28.02.2007
Main
Main
ISO 14971:2000
Amendment
ISO 14971:2000/Amd 1:2003
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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