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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]
Association for the Advancement of Medical Instrumentation [aami]