ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.
Static and dynamic loading is performed for the worst case scenario. Load transfer between the resection lines has to be guaranteed by the implant without bone support. Two UHMWPE blocks are used for implant fixation. The dynamic loading is performed at a frequency of 5 Hz and at up to 5 million cycles. In general six specimens are tested. Regular tests are performed in air at room temperature. The implant material may require test setups simulating body environmental conditions at 37°C in Ringers solution.
The following test procedures are described by the standard: Static and dynamic axial compression, static torsion and static tension. This standard is applicable for lumbar and cervical systems.