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Provides requirements on methods to perform security risk management for a medical device in the context of the safety risk management process required by ISO 14971. This document is intended to be used in conjunction with AAMI TIR57 and AAMI TIR97. 

Product Details

Published:

12/21/2022

ISBN(s):

9781570208621

ANSI:

ANSI Approved

Number of Pages:

61

File Size:

1 file , 1.5 MB

Note:

This product is unavailable in Russia, Ukraine, Belarus