ASTM-F1800 › Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
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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.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
arthroplasty; orthopaedic medical devices; tibial components; total knee arthroplasty; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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Feb. 1, 2013