2016 Edition, January 1, 2016
Technical Information Report: Principles for medical device security-Risk management
Active, Most Current
Description / Abstract:
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.