AI and Machine Learning - Related International Standards
The following non-harmonised international standards are related to AI and Machine Learning for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO/TS 24971-2:2026 | Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence | active | 14, 14.2, 17, 17.1, 17.2, 17.4 | Link |
| AAMI/BSI 34971:2023 | Application of ISO 14971 to machine learning in artificial intelligence - Guide | active | 14, 14.2, 17, 17.1 | Link |
| IEC PAS 63621:2026 | Artificial intelligence enabled medical devices - Data management | active | 14, 14.2, 17, 17.1, 17.2 | Link |
| ISO/IEC 5259-2:2024 | Artificial intelligence - Data quality for analytics and machine learning (ML) - Part 2: Data quality measures | active | 14, 17.1 | Link |
| ISO/IEC 5259-4:2024 | Artificial intelligence - Data quality for analytics and machine learning (ML) - Part 4: Data quality process framework | active | 14, 17.1 | Link |
| ISO/IEC TS 4213:2022 | Information technology - Artificial intelligence - Assessment of machine learning classification performance | active | 14, 14.2 | Link |
| ISO/IEC 23053:2022 | Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML) | active | 14, 17.1 | Link |
| ISO/IEC TR 24028:2020 | Information technology - Artificial intelligence - Overview of trustworthiness in artificial intelligence | active | 14, 17 | Link |
| ISO/IEC 23894:2023 | Information technology - Artificial intelligence - Guidance on risk management | active | 14, 14.2, 17 | Link |
| ISO/IEC 25024:2015 | Systems and software engineering - Systems and software Quality Requirements and Evaluation (SQuaRE) - Measurement of data quality | active | 14, 17.1 | Link |