ANSI/AAMI/ISO 14971:2019
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ANSI/AAMI/ISO 14971:2019

Medical devices—Application of risk management to medical devices

Summary

This 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 evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2019
Page Count 0
Themes General Aspects of Medical Devices
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