AS ISO 14971:2020

Medical devices - Application of risk management to medical devices

Standards Australia, 06/26/2020

Publisher: AS

File Format: PDF

$48.00$97.17

Description

Published:26/06/2020

Pages:37

File Size:1 file , 2.3 MB

Note:This product is unavailable in Ukraine, Russia, Belarus

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.

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