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AAMI TIR57:2016 (R2019)

Principles for medical device security - Risk management

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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Association for the Advancement of Medical Instrumentation [aami]

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