Like any medical device, spinal implants must be rigorously tested before human use. TestResources specializes in mechanical testing of medical implants. To verify long term strength of spinal implant designs simple static testing is required to evaluate the compressive, tensile and torsional loading required to fracture a spinal device.
Fatigue life tests are critical because fatigue failure is more common than catastrophic failure. Loading test samples with load-controlled sinusoidal waveforms is most common, and tests last in excess of ten million cycles.
The following standards specifically target spinal disc implants, and arthrodesis implants used in spinal fusion operations. ASTM F2346 and ISO 18192-2 are testing methods for spinal disc implants. They outline static and dynamic testing of spinal disc implants for comparison between various designs. ASTM F2706 and ISO 12189 are test methods for spinal implants used for spinal fusion operations. ASTM F1717 covers materials and methods for static and fatigue testing of spinal implant assemblies in a vertebrectomy.
TestResources suggests either a servohydraulic or servo electric t dynamic testing machines for fatigue testing medical implants. Servohydraulic test machines feature higher cyclic frequency capacity up to 100 Hz. Servoelectric test machines, such as the 830 and 810 series, feature lower load capacity and lower speed capacity then the servohydraulic models. However, this makes them much less expensive then the servohydraulic test machines and just as capable in terms of meeting the requirements of ASTM and ISO spinal implant fatigue testing standards. There are a wide variety of controllers that can be used with the dynamic test machines. TestResources application engineering team will fit the controller with the desired testing application to minimize cost and meet the desired performance.
Applicable Testing Standards
- ISO 12189 Fatigue Spinal Implant Test Equipment
- ASTM F1717 Spinal Implant Static and Fatigue Test Equipment
- ASTM F2346 Static and Dynamic Characterization of Spinal Artificial Disc Test Equipment
- ASTM F2706 Fatigue Static Spinal Implants Test Equipment
Recommended Test Machine
Static and fatigue forces up to 50 kN (11,250 lbf)
Frequency ratings up to 75 Hz
Oil-free, all electric actuator for clean test conditions
Lower purchase, operating, and maintenance costs than hydraulic equivalents
Force ratings up to 50 kN (11,250 lbf) and torque ratings up to 180 Nm (1,600 lbf∙in) Can apply axial and torsional loads simultaneously Performs both static and dynamic tests All electric and oil-free operation
Static and fatigue forces up to 25 kN (5,500 lbf)
Frequency ratings up to 100 Hz
Servohydraulic
Small, portable footprint
Recommended Accessories
TestResources offers a variety of options to allow you to freeze, bake, humidify, desiccate, or submerge your test specimen per your needs. These environmental enclosures are controlled to ensure the proper temperature throughout operation while also minimizing any leakage to the surrounding test area.