1.1 This practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover both the medial and lateral plateaus of the tibia. This practice may require modifications to accommodate other tibial tray designs. 1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with one unsupported condyle.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.