1.1 本规程涵盖了使用循环恒幅力对膝关节置换术中使用的金属胫骨托盘进行疲劳测试的程序。它适用于覆盖胫骨内侧和外侧平台的胫骨托盘。这种做法可能需要修改以适应其他胫骨托盘设计。 1.2 本规程旨在提供关于带有一个无支撑髁的金属胫骨托盘疲劳性能的有用、一致和可重复的信息。结果适用于实验室测试条件，可能与 体内 表演 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户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。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本规程可用于描述材料、制造和设计变量对金属胫骨托盘疲劳性能的影响，金属胫骨托盘承受相对较大的循环载荷。 4.2 胫骨托盘设计的负荷 体内 通常情况下，将不同于本实践中定义的荷载。此处获得的结果不能直接用于预测 体内 表演然而，当在类似条件下进行测试时，本规程旨在比较不同金属胫骨托盘设计的疲劳性能。 4.3 为了使胫骨托盘上的疲劳数据具有可比性、可重复性，并能够在实验室之间相互关联，必须建立统一的程序。

1.1 This practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements using a cyclic, constant-amplitude force. It applies to tibial trays that 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. The results are applicable to the laboratory test conditions and may not correlate with in vivo performance. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 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 practice 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.