AAMI TIR97:2019/(R)2023
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AAMI TIR97:2019/(R)2023

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

Summary

This technical information report (TIR) 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. No annex

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2019
Confirmation Date 01/01/2023
Page Count 56
Themes IT, Software, and Wireless
EAN ---
ISBN ---
Weight (in grams) ---
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