1.1 本试验方法涵盖了部分膝关节置换术中使用的金属胫骨托的疲劳试验程序。 1.2 本试验方法涵盖了使用循环恒定振幅力对金属胫骨部件进行疲劳试验的程序。它适用于覆盖胫骨内侧或外侧平台的胫骨托。 1.3 该测试方法可能需要修改以适应其他胫骨托设计。 1.4 该测试方法旨在提供关于髁突中段无支撑的金属胫骨托疲劳性能的有用、一致和可重复的信息。 1.5 以国际单位制表示的数值应视为标准。本标准中不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ===意义和用途====== 4.1 该试验方法可用于描述材料、制造和设计变量对金属胫骨托在相对大量循环的循环载荷下的疲劳性能的影响。 4.2 胫骨托设计的载荷 体内 一般而言，将与本实践中定义的荷载不同。此处获得的结果不能用于直接预测 体内 表演然而，当在类似条件下进行测试时，该实践旨在比较不同金属胫骨托设计的疲劳性能。 4.3 为了使胫骨托上的疲劳数据具有可比性、可重复性，并能够在实验室之间进行关联，制定统一的程序至关重要。

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. ====== Significance And Use ====== 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.