AAMI CR515:2025
Current
Current
The latest, up-to-date edition.
Cybersecurity considerations unique to machine learning–enabled medical devices
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
23-06-2025
€148.85
Excluding VAT
This consensus report specifically addresses the unique cybersecurity threats associated with developing and deploying machine learning–enabled medical device software, as distinct from the broader cybersecurity risks applicable to all medical device life cycle phases.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-912-3
|
| Pages |
26
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ISO/IEC 24029-2:2023 | Artificial intelligence (AI) — Assessment of the robustness of neural networks — Part 2: Methodology for the use of formal methods |
| ISO/IEC 23894:2023 | Information technology — Artificial intelligence — Guidance on risk management |
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