1.1 本测试程序提供了一种在实验室条件下使用交互摩擦模拟器确定全髋关节置换（THR）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。本试验方法规定了铰接部件之间的角运动、施加力的模式以及测量和分析数据的方式。 1.2 使用该测试方法可以研究许多变量，包括但不限于头部尺寸、不同倾角/倾角、髋臼杯的不同变形程度、轴承间隙、润滑、擦伤头部和人工老化的影响。 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====== 5.1 该测试程序提供了一种评估髋关节置换术轴承摩擦扭矩和摩擦系数的方法。 5.2 该程序可用作测量摩擦力的标准方法，以研究特定测试参数的影响，例如髋部材料、尺寸、设计、径向或径向间隙、不同润滑剂、髋臼杯的不同变形程度、夹紧（不均匀球形）、损坏/刮伤的轴承、人工老化、安装过程中的错位等。 5.3 摩擦扭矩，尤其是最大值，有助于评估可能影响固定的适用扭矩，甚至有可能通过杠杆使髋臼杯或内衬/外壳组件中的模块化组件分离- 向外或向外扭转机构。 5.4 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）。 5.5 髋关节置换术的负荷和运动 体内 与本标准中定义的载荷和运动不同。摩擦力的大小 体内 通常，将不同于本标准试验方法评估的摩擦力。从该测试方法获得的结果不能直接用于预测 体内 表演 然而，本标准旨在允许 体外试验 在类似条件下测试时，比较不同髋部设计。 5.6 虽然该测试方法可用于调查表1.2.1中列出的许多变量 1.2 和 5.2 ，它既没有提供一种方法来预先确定这些变量的组合，这些变量将在一系列尺寸中产生最坏情况的耦合；“正常”或“不利”条件的最坏测试条件；或者提供使髋臼杯变形的具体方法，模拟模式3磨损条件（例如，第三体颗粒、擦伤的头部）或人工老化的材料。由于这些方法不包括在标准中，并且如果它们将成为调查的对象，则应由用户证明所选的夫妇和测试中使用的方法是合理的，并且在必要的情况下，为“最坏情况”如何进行提供理由- 作为报告的一部分，选择“病例”对和方法来代表临床相关的“正常”和“不利”条件。

1.1 This test procedure provides a method of determining the frictional torque and friction factor of artificial hip joint bearings used in total hip replacement (THR) systems under laboratory conditions using a reciprocal friction simulator. This test method specifies the angular movement between the articulating components, the pattern of applied force, and the way data can be measured and analyzed. 1.2 Many variables can be investigated using this test method including, but not limited to, the effect of head size, different inclination/version angles, different deformation levels of the acetabular cup, bearing clearances, lubrication, scratched heads, and artificial ageing. 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 ====== 5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of hip replacement bearings. 5.2 The procedure may be used as a standardized method of measuring friction to investigate the effects of specific test parameters such as hip materials, sizes, designs, radial or diametral clearance, different lubricants, different deformation levels of the acetabular cup, clamping (non-uniform sphericity), damaged/scratched bearings, artificial ageing, misalignments during installation, etc. 5.3 Friction torque, and in particular the maximum value, is useful to assess the applicable torques that may compromise fixation, or even risk disassociation of modular components in the acetabular cup or liner/shell assemblies through a lever-out or torsion-out mechanism. 5.4 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). 5.5 The loading and motion of a hip replacement in vivo differ from the loading and the motion defined in this standard. The amount of frictional forces in vivo will, in general, differ from the frictional forces evaluated by this standard test method. The results obtained from this test method cannot be used to directly predict in vivo performance. However, this standard is designed to allow for in-vitro comparisons for different hip designs, when tested under similar conditions. 5.6 Although this test method can be used to investigate the many variables listed in 1.2 and 5.2 , it does not either provide a method to determine beforehand the combination of these variables that will produce the worst-case couple(s) among a range of sizes; the worst-case testing condition(s) for “normal” or “adverse” conditions; or provide specific methods to deform the acetabular cup, simulate Mode 3 wear conditions (for example, third-body particles, scratched heads), or artificially aged materials. As these methods are not included in the standard and if they are to become the subject of the investigation then it is up to the user to justify the couple(s) selected and method(s) used in the test and, if necessary, provide a rationale for how the “worst-case” couple(s) and method(s) were selected to represent clinically relevant “normal” and “adverse” conditions as part of the report.