Vascular Devices - Related International Standards
The following non-harmonised international standards are related to Vascular Devices for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 25539-1:2017 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses | active | 1, 3, 5, 10 | Link |
| ISO 25539-3:2024 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters | active | 1, 3, 5, 10 | Link |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches | active | 1, 3, 5, 10 | Link |
| ISO 25539-4:2021 | Cardiovascular implants - Endovascular devices - Part 4: Coils and flow diverters | active | 1, 3, 5, 10 | Link |
| ISO 12417-1:2024 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements | active | 1, 3, 5, 10 | Link |