1.1 这些测试方法包括评估陶瓷模块化股骨头的循环疲劳强度，该股骨头安装在锥形上，用于全髋关节置换术的股骨柄。 1.2 这些试验方法主要用于评估陶瓷（规范 F603 ，ISO 6474-1，ISO 6474-2，ISO 13356）金属锥头设计，但可能适用于其他材料。 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 这些测试方法可用于确定头和椎体材料、设计变量、制造和其他条件对安装在股骨假体椎体上的模块化股骨头的循环承载能力的影响。 4.2 模块化股骨头的载荷 体内 通常情况下，将不同于这些方法中定义的载荷。此处获得的结果不能直接用于预测 体内 表演然而，这些方法的设计允许在类似条件下测试时比较不同陶瓷模块化股骨头设计的疲劳性能。 4.3 这些测试方法可以使用实际的股骨假体或简化几何形状的颈锥模型，其几何和材料特征与植入物中的相同。在任何一种情况下，所选试样的匹配金属锥区域的材料、公差和光洁度应与最终的股骨假体相同。 4.4 在疲劳试验方法中，公认实际载荷 体内 是多种多样的，没有一套实验条件可以涵盖所有可能的变化。 因此，此处包含的试验方法代表了一个简化模型，用于设计和材料之间的比较。这些试验方法拟在生理溶液中进行。 4.5 试验数据可能会产生关于不同封头和锥体设计的相对强度的有价值信息。

1.1 These test methods cover the evaluation of the cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty. 1.2 These test methods were primarily developed for evaluation of ceramic (Specification F603 , ISO 6474-1, ISO 6474-2, ISO 13356) head designs on metal cones but may have application to other materials. 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 These test methods can be used to determine the effects of head and cone materials, design variables, manufacturing, and other conditions on the cyclic load-carrying ability of modular femoral heads mounted on the cones of femoral stem prostheses. 4.2 The loading of modular femoral heads in vivo will, in general, differ from the loading defined in these methods. The results obtained here cannot be used to directly predict in-vivo performance. However, these methods are designed to allow for comparisons between the fatigue performance of different ceramic modular femoral head designs, when tested under similar conditions. 4.3 These test methods may use actual femoral prostheses or neck-cone models of simplified geometry with the same geometrical and material characteristics as in the implants. In either case, the matching metallic cone region of the test specimen selected shall be of the same material, tolerances, and finish as the final femoral stem prosthesis. 4.4 In the fatigue test methods, it is recognized that actual loading in vivo is quite varied, and that no one set of experimental conditions can encompass all possible variations. Thus, the test methods included here represent a simplified model for the purposes of comparisons between designs and materials. These test methods are intended to be performed in physiological solution. 4.5 The test data may yield valuable information about the relative strengths of different head and cone designs.