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Tibial tray fatigue test ISO 14879 / ASTM F1800

Normative References  



ISO 14879: Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays

ISO 21536: Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants

ASTM F1800: Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

ASTM F2083: Standard Specification for Total Knee Prosthesis

Tibial trays of a total knee endoprosthesis are subjected to fatigue stress. The worst case condition occurs if medial loading is applied without bone support. To simulate this worst case condition the tibial trays are fixed unilaterally using a metal block. To avoid restraint forces, EndoLab® uses a load application mechanism which is able to move freely in the horizontal plane.
Safety against fracture is determined up to 10 million cycles, testing five implants at 900 N maximum load (ASTM as well as ISO requirements). Due to clinical fractures occurring on implants that have been seen for implants being successfully tested at 900 N, the EndoLab® recommends testing at a higher load level of 2,000 N instead of 900 N.