【国外标准】 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.1.2 This test method 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 either the medial or the lateral plateau of the tibia.1.3 This test method may require modifications to accommodate other tibial tray designs.1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.