1.1 本标准中包含的测试方法包括两个全膝关节置换术（TKR）中使用的陶瓷股骨组件静态爆裂测试程序。这两个程序用于确定陶瓷股骨膝关节组件的静态极限失效载荷。两个过程都在模拟 体内 装载条件。其中一个程序还模拟了术中负荷情况。该标准适用于覆盖股骨内侧髁和外侧髁以及髌骨表面的交叉韧带固定（CR）股骨部件。这些测试方法可能需要修改以适应其他股骨组件设计。 1.2 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。 1.3 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。 1.4 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====== 5.1 这些试验方法旨在确定陶瓷股骨膝关节组件的极限失效载荷。这些信息可用于评估不同的陶瓷部件设计或不同的陶瓷材料，或用于系列生产控制。 5.2 尽管测试方法描述了识别生理相关术中和 体内 加载条件下，对结果的解释仅限于 体外 陶瓷股骨部件设计和材料在规定试验条件下的静态极限失效载荷的比较。

1.1 The test methods included in this standard cover two procedures for static burst testing of a ceramic femoral component used in total knee replacement (TKR). The two procedures are used to determine the static ultimate failure load of a ceramic femoral knee component. Both procedures are simulating in vivo loading conditions. One of the procedures additionally simulates intraoperative loading conditions. The standard applies to cruciate retaining (CR) femoral components which cover both the medial and lateral condyles and the patellar surface of the femur. These test methods may require modifications to accommodate other femoral component designs. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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 These test methods are intended to determine the ultimate failure load of a ceramic femoral knee component. This information can be used for evaluation of different ceramic component designs or different ceramic materials, or for series production control. 5.2 Although the test methodology described attempts to identify physiologically relevant intraoperative and in vivo loading conditions, the interpretation of results is limited to an in vitro comparison between ceramic femoral component designs and materials regarding their static ultimate failure load under the stated test conditions.