1.1 本规程描述了使用重量损失（即质量损失；请参阅）的实验室方法 X1.4 )用于评估聚合物材料或装置磨损性能的技术，这些材料或装置被视为人类关节置换假体的支承面。在模拟人体关节摩擦条件的装置中对试样进行评估；例如，使用诸如牛血清或等效的假滑液等流体模拟发现的类似磨损机制和碎屑生成 体内 . 1.2 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 本规程使用失重法测定人体关节假体中使用的聚合物组件或材料的磨损，使用血清或经证明的等效流体进行润滑，并在代表适当人体关节应用的负荷曲线下运行 ( 1. , 2. ) . 4. 最初开发了这种用于磨损测量的失重方法的基础 ( 3. ) 针盘磨损研究（实践 F732 )并已扩展到全髋关节置换术 ( 4. , 5. ，ISO 14242–2和指南 F1714 ) ，以及股骨-胫骨膝盖假体 ( 6. 和ISO 14243–2 ) ，以及股骨-髌骨膝盖假体 ( 6. , 7. ) . 3.2 虽然磨损会导致试样物理尺寸的变化，但与蠕变或塑性变形引起的尺寸变化不同，因为磨损会导致聚合物碎屑颗粒形式的材料去除，从而导致试样的重量损失。 3.3 这种测量聚合物部件磨损的方法适用于各种模拟装置。这些技术可用于金属、陶瓷、碳、聚合物和复合物对立面，对聚合物材料（例如，聚乙烯、聚缩醛等）进行支承。因此，这种减肥方法在以聚合物轴承为特征的人类关节置换的磨损研究中具有普遍应用。这种失重方法尚未验证用于非聚合物材料轴承系统，如金属、碳或陶瓷。通常使用线性可变位移传感器或其他轮廓测量技术监测此类刚性轴承组合的渐进磨损。

1.1 This practice describes a laboratory method using a weight-loss (that is, mass-loss; see X1.4 ) technique for evaluating the wear properties of polymeric materials or devices which are being considered for use as bearing surfaces of human joint replacement prostheses. The test specimens are evaluated in a device intended to simulate the tribological conditions encountered in the human joint; for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation found in vivo . 1.2 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 practice uses a weight-loss method of wear determination for the polymeric components or materials used in human joint prostheses, using serum or demonstrated equivalent fluid for lubrication, and running under a load profile representative of the appropriate human joint application ( 1 , 2 ) . 4 The basis for this weight-loss method for wear measurement was originally developed ( 3 ) for pin-on-disk wear studies (Practice F732 ) and has been extended to total hip replacements ( 4 , 5 , ISO 14242–2, and Guide F1714 ) , and to femoro-tibial knee prostheses ( 6 and ISO 14243–2 ) , and to femoro-patellar knee prostheses ( 6 , 7 ) . 3.2 While wear results in a change in the physical dimensions of the specimen, it is distinct from dimensional changes due to creep or plastic deformation, in that wear results in the removal of material in the form of polymeric debris particles, causing a loss in weight of the specimen. 3.3 This practice for measuring wear of the polymeric component is suitable for various simulator devices. These techniques can be used with metal, ceramic, carbon, polymeric, and composite counter faces bearing against a polymeric material (for example, polyethylene, polyacetal, and so forth). Thus, this weight-loss method has universal application for wear studies of human joint replacements which feature polymeric bearings. This weight-loss method has not been validated for non-polymeric material bearing systems, such as metal-metal, carbon-carbon, or ceramic-ceramic. Progressive wear of such rigid bearing combinations has generally been monitored using linear, variable-displacement transducers, or by other profilometric techniques.