Active Implants - Related International Standards
The following non-harmonised international standards are related to Active Implants for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 14708-6:2019 | Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | active | 14, 18, 19 | Link |
| ISO 14708-2:2019 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers | active | 10, 14, 14.2 | Link |
| ISO 14708-3:2017 | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators | active | 10, 14, 14.1 | Link |
| ISO 14708-7:2019 | Implants for surgery - Active implantable medical devices - Part 7: Cochlear implant systems | active | 10, 14, 14.1 | Link |