1.1 本试验程序提供了一种评估全髋关节置换系统中使用的人工髋关节轴承的摩擦扭矩和摩擦系数的方法。本文提出的方法基于一项已发表的研究，首次作为2008年的会议论文 ( 1. ) 2. 然后作为同行评审的期刊论文 ( 2. ) . 该方法与配备多自由度力和力矩传感器的磨损模拟器兼容，并且能够在全髋关节置换植入物的实际磨损测试期间执行。 1.2 虽然所述方法不能复制所有生理负荷条件，但它是一种 体外试验 在规定的试验条件下，比较全髋关节置换系统中使用的人工髋关节轴承的摩擦扭矩和摩擦系数。 1.3 单位- 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====== 5.1 本试验程序提供了一种在规定条件下评估人工髋关节轴承摩擦扭矩和摩擦系数的方法 体外试验 试验条件。 5.2 摩擦不仅仅是一种材料属性。试样系统及其对其摩擦的影响是多因素的，包括部件的材料和加工、部件的设计和组装、测试参数和环境因素（润滑剂、温度等）。 5.3 该程序可作为测量特定系统摩擦的标准方法，或作为调查特定测试参数影响的方法，例如髋部尺寸、设计、径向间隙、不同润滑剂、夹紧（不均匀球形）、安装过程中的错位等。 5.4 该程序可用于研究试样磨损时摩擦随时间的变化，这对于经历从“磨合”到“稳态”磨损行为过渡的试样特别有用。由于运动和载荷波形与ISO 14242-1:2014中规定的波形相同，因此可以组合标准化摩擦和磨损测量，并从正确的角度观察它们之间的相互影响。 5.5 摩擦扭矩，尤其是最大值，有助于评估可能影响固定的扭矩，或通过撬出或扭转机制导致髋臼杯或内衬/外壳组件中模块化组件分离的扭矩。 5.6 摩擦系数是比较材料和设计的一个有用参数，可以深入了解植入系统中的润滑状态。 摩擦系数测量也可以检测髋臼内衬变形（之前提到的夹紧）。

1.1 This test procedure provides a method of evaluating the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems. The method presented here was based on a published study, first as a conference paper in 2008 ( 1 ) 2 and then as a peer-reviewed journal paper ( 2 ) . The method is compatible with and is capable of being carried out during actual wear testing of total hip replacement implants on wear simulators equipped with multiple degrees of freedom force and moment sensors. 1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems under the stated test conditions. 1.3 Units— 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 ====== 5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of artificial hip joint bearings under the stated in-vitro test conditions. 5.2 Friction is not simply a materials property. The specimen system and the effects on its friction are multi-factorial, including the materials and processing of the components, the design and assembly of the components, the test parameters, and environmental factors (lubricant, temperature, etc.). 5.3 The procedure may be used as a standardized method of measuring friction for a particular system, or as a method of investigating the effects of specific test parameters such as hip sizes, designs, radial clearance, different lubricants, clamping (nonuniform sphericity), misalignments during installation, etc. 5.4 The procedure may be used to study the variation of friction with time as the specimens wear, which is particularly useful for samples that undergo a transition from “run-in” to “steady-state” wear behavior. Since the motion and load waveforms are identical to those specified in ISO 14242-1:2014, standardized friction and wear measurements may be combined and viewed in the correct perspective where they affect each other. 5.5 Frictional torque, and in particular the maximum value, are useful to assess the torques that may compromise fixation, or cause disassociation of modular components in acetabular cup or liner/shell assemblies through a lever-out or torsion-out mechanism. 5.6 Friction factor is a useful parameter for comparison of materials and designs, and provides insights into the lubrication regime operating in the implant system. Friction factor measurement may also be able to detect acetabular liner deformation (clamping referred to earlier).