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.
Document identifier
AAMI TIR57:2016
Title
Principles for medical device security - Risk management
AAMI Category
General Aspects of Medical Devices
Publication date
2016-08-03
International Relationship
| Price |
282 vnd |
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