AAMI TIR57:2016/(R)2019

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Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.

Product Details

Published:
06/05/2016
ISBN(s):
9781570206122
ANSI:
ANSI Approved
Number of Pages:
84
File Size:
1 file , 4.8 MB

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