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AS ISO 14971:2020
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AS ISO 14971:2020 Medical devices - Application of risk management to medical devices
standard by Standards Australia, 06/26/2020
Full Description
This document adopts ISO 14971:2019, which 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.
M00000142
2021-02-15
New product
AS ISO 14971:2020 Medical devices - Application of risk management to medical devices
standard by Standards Australia, 06/26/2020