PDF Standards AAMI TIR57:2016/(R)2019

Click here to purchase
Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.

Product Details

Published:

06/05/2016

ISBN(s):

9781570206122

ANSI:

ANSI Approved

Number of Pages:

84

File Size:

1 file , 4.8 MB

Note:

This product is unavailable in Russia, Ukraine, Belarus