AAMI - TIR57
Technical Information Report: Principles for medical device security-Risk management
inactive
| Organization: | AAMI |
| Publication Date: | 1 January 2016 |
| Status: | inactive |
| Page Count: | 84 |
scope:
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 History
January 1, 2016
Principles for medical device security—Risk management
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
This guidance is intended to assist manufacturers and other users...
January 1, 2016
Technical Information Report: Principles for medical device security—Risk management
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
This guidance is intended to assist manufacturers and other users...
TIR57
January 1, 2016
Technical Information Report: Principles for medical device security-Risk management
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...