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.
Document identifier
AAMI TIR97:2019
Title
Principles for medical device security - Postmarket risk management for device manufacturers
AAMI Category
General Aspects of Medical Devices
Publication date
2019-09-27
International Relationship
Price |
243 vnd |