1.1 本试验方法描述了一种实验室方法，用于评估在重复力作用下移动轴承膝盖-胫骨基板/轴承分离的可能性。 1.2 所述试验适用于任何带轴承保持机构的两班制活动轴承膝盖。经过修改，该测试可应用于具有轴承保持机构的单室移动轴承膝盖。 1.3 虽然所述方法不能复制所有生理力条件，但它是一种 体外试验 在规定的试验条件下，比较移动式承重膝盖设计和胫骨底板和承重部件之间承重保持机构的强度。 1.4 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。 1.5 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。 1.6 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====== 3.1 该试验方法包括使用静态和疲劳剪切力和弯曲力条件来评估移动轴承膝盖设计的轴承保持机制及其防止分离的能力。 3.2 通常，在接触位置位于支承面边界内的活动期间不会发生分离。分离最有可能发生在轴承组件边缘的力或后稳定膝-胫骨组件桩上的较大AP剪力。极端的轴承旋转、骨/轴承撞击、严重的内翻或外翻力矩、高度屈曲或这些因素的任何组合都会增加分离的可能性。 3.3 所述试验方法适用于任何带轴承保持机构的两班活动轴承膝盖。经过修改，该测试可应用于具有轴承保持机构的单室移动轴承膝盖。

1.1 This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces. 1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism. 1.3 Although the methodology described does not replicate all physiological force conditions, it is a means of in-vitro comparison of mobile bearing knee designs and the strength of the bearing retention mechanism between the tibial baseplate and bearing components under the stated test conditions. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. 1.6 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 ====== 3.1 This test method includes the use of static and fatigue shear and bending force conditions to evaluate the bearing retention mechanism of a mobile bearing knee design and its ability to prevent disassociation. 3.2 In general, disassociation does not occur during activities where the contact locations are within the boundaries of the bearing surfaces. Disassociation is most likely to occur with forces at the edges of the bearing component or with large AP shear forces on a posterior stabilized knee tibial component post. Extreme bearing rotation, bone/bearing impingement, severe varus or valgus moments, high flexion, or any combination of these can increase the likelihood of disassociation. 3.3 The test method described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.