A Guide to Cyclic Fatigue Testing of Spinal Implant Constructs in accordance with ASTM F1717-18, ASTM F2706-18 and ISO 12189-8

ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM 2706, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model, specify methods for both the static and fatigue testing of spinal implant assemblies. The tests include:

Static compressive bending

Static tensile bending

Static torsion

Dynamic compressive bending fatigue

ISO 12189, Implants for surgery Mechanical testing of implantable spinal devices Fatigue test method for spinal implant assemblies using an anterior support, species a very similar Dynamic compressive bending fatigue test.

For the majority of spinal construct testing, ultra-high molecular weight polyethylene (UHMWPE) blocks are used rather than vertebrae to eliminate variations in bone properties and geometry that may be present.

TEST SYSTEM

HST-EFT-A  Electric Dynamic Test Instrument or a HFT-A servohydraulic testing system.

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