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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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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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