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ANSI/AAMI SW96:2023

Standard for medical device security - Security risk management for device manufacturers

Provides requirements on methods to perform security risk management for a medical device in the context of the safety risk management process required by ISO 14971. This document is intended to be used in conjunction with AAMI TIR57 and AAMI TIR97.

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Association for the Advancement of Medical Instrumentation [aami]

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