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AAMI TIR57:2016
Principles for Medical Device Security - Risk ManagementMore info
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.
| Author | AAMI |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| EAN ISBN | 1570206120 |
| ICS | 11 : Health care technology |
| Number of pages | 80 |
| Year | 2016 |
| Country | USA |