Risk Management - Related International Standards
The following non-harmonised international standards are related to Risk Management for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices | active | 1, 2, 3, 4, 5, 6, 7, 8, 9 | Link |
| ISO/TR 24971:2020 | Medical devices - Guidance on the application of ISO 14971 | active | 2, 3, 3(e), 3(a), 3(c), 3(b) | Link |
| IEC 80001-1:2021 | Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software | active | 1, 2, 3, 17 | Link |
| EN ISO 14971:2019/A11:2021 | Medical devices - Application of risk management to medical devices - Annex ZA/ZB/ZC (EU regulatory deviation) | active | 1, 2, 3 | Link |