AAMI TIR97:2019/(R)2023

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

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

Publisher: AAMI

File Format: PDF

$146.00$293.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 09/27/2019

Published:09/27/2019

Pages:56

ISBN(s):9781570207259

File Size:1 file , 1.3 MB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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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