AAMI TIR57: 2016

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.

Association for the Advancement of Medical Instrumentation [aami]

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Principles for medical device security - Postmarket risk management for device manufacturers
Guidance on the use of AGILE practices in the development of medical device software
Medical device software - Part 1:Guidance on the application of ISO14971 to medical device software
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