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AAMI TIR97:2019

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AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers

standard by Association for the Advancement of Medical Instrumentation, 09/27/2019

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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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Published: 09/27/2019 ISBN(s): 9781570207259 Number of Pages: 56 File Size: 1 file , 1.3 MB