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AAMI TIR57:2016/(R)2019

Principles for medical device security—Risk management

This Technical Information Report (TIR) 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.

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TIR572019PDF
September 03, 2019
978-1-57020-612-2
PDF
84
$168.00
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