ISO 12189 Fatigue test using anterior support

We offer a characterization of the fatigue behavior of spinal implants according to the test standard ISO 12189. This test is intended for implants which are not suitable for an examination in the corpectomy model.

The implant is firmly connected to test-blocks of UHMW-PE, which simulate the vertebral bodies. The number and type of test-blocks is selected depending on the simulated spinal position (lumbar or cervical). Three springs with defined stiffnesses are place between the test-blocks in order to mirror the discs. The construct of implant and vertebral bodies is clamped in the test device and sinusoidally loaded with a maximum frequency of 5 Hz (lumbal: 0.6 kN - 2.0 kN and cervical: 0.05 kN - 0.15 kN). The test runs over 5 million cycles or until a failure of the implant occurs. In addition, the strength of the implant is statically determined.

Optionally, the static tests can also be performed according to ASTM F1717. In addition, we offer to carry out the dynamic test in a Ringer solution (0.9% NaCl solution) at 37 °C in order to simulate the physiological ambient conditions and to consider possible corrosive effects.