Evaluation of Medical Equipment/Implant Materials
Bending Fatigue Tests of Osteosynthesis Devices in Pseudo Physiological Solution
Evaluation of durability of bone plates in simulated body fluid.
Outline of Measurement Technology
The durability of osteosynthesis parts is evaluated by 4-point bending or 3-point bending in water or simulated body fluid (SBF). Test jigs and conditions are designed referring to JIS T 0312 or ASTM F382, which are test standards for osteosynthesis parts in the atmosphere, and tests are performed in SBF kept at the temperature of 37℃.
Outline of Test
| Test environment | 37 ± 2℃, in liquid (distilled water or simulated body fluid) |
|---|---|
| Test method | Bending fatigue test (3-point bending or 4-point bending) |
| Max. load | 10kN |
| Max. cycle frequency | 2Hz * |
| Types of test specimens | Bone plates, CHS (compression hip screw), screws, lag screws |
*For other test frequencies, please consult JFE-TEC.
Example of Measurement of Bending Fatigue Strength of Intramedullary Nail
Example of Test
| Cycle frequency | : | 1Hz |
|---|---|---|
| Load ratio | : | 0.1 |
| Test environment | : | 37°C Phosphate buffered saline (PBS) |
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