1.1 本试验方法旨在提供一种标准化方法，以确定移动轴承膝盖设计在股骨组件分离和旋转/吐出移动轴承嵌件方面的抗脱位能力。 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，比较活动支座膝盖设计及其抵抗活动支座从股骨或胫骨部件脱位的能力。 1.3 试验方法仅适用于移动轴承全膝关节设计。 1.4 以国际单位制表示的数值视为标准值。 括号中给出的值是英寸-磅单位的数学转换，仅供参考，不被视为标准值。 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====== 4.1 本试验方法旨在提供一种标准化方法，以确定移动轴承膝盖设计在旋转和吐出移动轴承方面的约束。 4.2 与全膝约束测试类似（见测试方法 F1223 )值得注意的是，试验方法没有模拟膝关节的软组织和松弛，这可能是与旋出或吐出发生相关的关键因素。 3. 例如，软组织约束良好的患者可能需要较低的旋出/吐出阻力，而严重骨质流失或韧带结构破坏的患者可能需要较高的旋出阻力的植入物- 排除/吐出阻力。因此，测试结果应与患者软组织的状况一起考虑，以确定设备的相对安全性。

1.1 This test method is designed to provide a standardized method to determine the dislocation resistance of mobile bearing knee designs with regard to femoral component disassociation and spin-out/spit-out of the mobile bearing insert. 1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of mobile bearing knee designs and their ability to resist dislocation of the mobile bearing from the femoral or tibial components under stated test conditions. 1.3 The test method applies only to mobile bearing total knee designs. 1.4 The values stated in SI units are regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 ====== 4.1 This test method is designed to provide a standardized method to determine the constraint of mobile bearing knee designs with regard to spin-out and spit-out of the mobile bearing. 4.2 Similar to constraint testing of total knees (see Test Method F1223 ), it is important to note that the test method does not simulate the soft tissues and laxity of the knee joint, which may be key factors related to the occurrence of spin-out or spit-out. 3 For instance, a patient with good soft tissue restraints will perhaps require a lower spin-out/spit-out resistance, whereas a patient with major bone loss or destroyed ligamentous structures will likely require an implant with a higher spin-out/spit-out resistance. Therefore, the results from the test should be taken into account along with the condition of the patient’s soft tissues to determine the relative safety for the device.