1.1 本标准规定了在特定实验室条件下测定双腔或三腔膝关节假体设计中使用的超高分子量聚乙烯（UHMWPE）胫骨支承部件的耐久性和变形的试验方法。 1.2 该试验方法旨在模拟类似于在高屈曲运动（如蹲下或跪下）期间发生的载荷类型的近后缘载荷。 1.3 尽管所描述的方法试图识别生理取向和负荷条件，但对结果的解释仅限于 体外 膝关节假体设计及其在规定试验条件下抵抗变形和骨折的能力之间的比较。 1.4 本试验方法适用于由UHMWPE制造的轴承部件。 1.5 该测试方法可适用于单室全膝关节置换术（TKR）系统，前提是单室系统的设计有足够的约束条件，允许使用该测试方法。该测试方法不包括将两个单室膝关节作为双室系统进行测试的说明。 1.6 以国际单位制表示的数值应视为标准。本标准中不包括其他计量单位。 1.7 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ===意义和用途====== 4.1 该试验方法可用于描述材料、制造和设计变量对UHMWPE轴承部件疲劳/循环蠕变性能的影响，这些部件在横向平面（相对于胫骨托）内进行了相对大量的循环。 4.2 轴承部件设计的载荷和运动学 体内 一般而言，将不同于本试验方法中定义的载荷和运动学。 此处获得的结果不能用于直接预测 体内 表演然而，该测试方法旨在比较在类似条件下测试时不同轴承部件设计的疲劳性能。 4.3 所述测试适用于任何双腔膝关节设计，包括在胫骨关节部件中具有限制股骨部件向后运动的机构的活动支承膝关节，以及将关节部件保持在胫骨板上的内置保持机构。

1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs. 1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling. 1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions. 1.4 This test method applies to bearing components manufactured from UHMWPE. 1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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 can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles. 4.2 The loading and kinematics of bearing component designs in vivo will, in general, differ from the loading and kinematics defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparisons between the fatigue performance of different bearing component designs when tested under similar conditions. 4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.