Evaluation of Medical Equipment/Implant Materials

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Bending Fatigue Tests of Osteosynthesis Devices in Pseudo Physiological Solution

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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)
Schematic diagram of fatigue test
Schematic diagram of fatigue test

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In addition to Japanese, we can also provide test reports in accordance with ASTM, ISO and other standards in English.

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