Static and Dynamic Testing for Interconnection Mechanisms and Subassemblies in Spinal Implants
The interconnection mechanisms of spinal arthrodesis implants are tested for uniaxial static and fatigue strength, and resistance to loosening for the purpose of mechanical and design evaluations. The directions of loading shall follow those relevant to which the interconnection is designed to provide resistance to loading. Fatigue tests shall reach a run-out of 2.5 million cycles or functional failure.
