1.1 本试验方法涵盖了髋关节置换中使用的金属股骨髋关节假体的疲劳试验程序。本试验方法涵盖了使用循环恒幅力对金属股骨髋关节股骨柄进行疲劳试验的程序。本发明适用于采用近端干骺端固定且为模块化结构的髋关节假体，旨在评价股骨柄干骺端填充（即近端体）区域中模块化连接的疲劳性能。 1.2 本试验方法旨在提供关于金属髋关节假体以近端固定方式固定（远端未被灌封介质固定）时疲劳性能的有用、一致和可重复的信息。 1.3 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 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、制造和设计变量对承受大量循环循环载荷的金属股骨髋关节假体疲劳性能的影响。4.2 股骨髋关节设计的载荷 体内 通常与本试验方法中定义的载荷不同。这里得到的结果不能用来直接预测 体内 性能。然而，该测试方法旨在允许在相似条件下测试时比较不同金属股骨髋关节设计的疲劳性能。 4.3 为了使股骨髋关节假体的疲劳数据在实验室之间具有可比性、可再现性和相关性，必须建立统一的程序。

1.1 This test method covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This test method covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem. 1.2 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium. 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 test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic femoral hip prostheses subject to cyclic loading for large numbers of cycles. 4.2 The loading of femoral hip designs in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to allow for comparisons between the fatigue performance of different metallic femoral hip designs when tested under similar conditions. 4.3 In order for fatigue data on femoral hip prostheses to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.