Implant Testing - Related International Standards
The following non-harmonised international standards are related to Implant Testing for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ASTM F2129-25 | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices | active | 10, 10.3 | Link |
| ASTM F2052-21 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | active | 10, 16 | Link |
| ASTM F2213-25 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | active | 10, 16 | Link |
| ASTM F2182-19e2 | Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging | active | 10, 16 | Link |
| ASTM F1717-21 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | active | 10, 10.1 | Link |
| ASTM F1264-24 | Standard Specification and Test Methods for Intramedullary Fixation Devices | active | 10, 10.1 | Link |