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AAMI TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers

Provides guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. This TIR is intended to be used in conjunction with AAMI TIR57:2016.

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Association for the Advancement of Medical Instrumentation [aami]

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Document History
Revises:
  • TIR 62:2014)
Revised By:
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