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AAMI TIR97:2019/(R)2023

Principles for medical device security - Postmarket risk management for device manufacturers

standard by Association for the Advancement of Medical Instrumentation , 09/27/2019

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Provides guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. This TIR is intended to be used in conjunction with AAMI TIR57:2016.
 

Product Details

Published:
09/27/2019
ISBN(s):
9781570207259
Number of Pages:
56
File Size:
1 file , 1.3 MB
Note:
This product is unavailable in Russia, Ukraine, Belarus