1.1 本规程规定了使用有限元分析（FEA）技术对金属骨科全膝-胫骨组件进行数值模拟的要求和注意事项，以估算应力和应变。本规程仅适用于材料认证中规定的屈服强度以下的应力。 1.2 目的- 本规程规定了开发有限元模型的要求和注意事项，用于评估金属骨科全膝-胫骨组件设计，以预测静态植入物应力和应变。 该程序可用于同一植入物设计的一系列不同植入物尺寸内的最坏情况评估，以减少物理测试负担。提供了执行模型检查和验证的推荐程序，以帮助确定分析是否遵循推荐的指南。最后，介绍了涵盖机械模拟的工程报告的推荐内容。 1.3 限制- 本实践仅限于讨论金属骨科全膝-胫骨组件的静态结构分析（不包括疲劳强度预测）。 1.4 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。 1.5 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 本规程适用于计算以本规程所述方式加载时膝盖-胫骨组件上的应力。这种做法可用于确定特定植入物的最坏尺寸。当使用该有限元方法计算的应力与在一个实验室使用物理应变测量技术在胫骨托盘上的两个位置测量的应力进行比较时，观察到的差异在一个位置为-6.8%（应变计报告较高的应力），在另一个位置为3.1%（有限元方法报告较高的应力）。 在确定相同植入物设计的最坏尺寸时，应考虑这种差异。 3.2 胫骨托盘设计的负荷 体内 通常情况下，将不同于本实践中定义的荷载。然而，当在类似条件下进行测试时，本规程旨在允许比较不同金属胫骨部件设计的疲劳性能。

1.1 This practice establishes requirements and considerations for the numerical simulation of metallic orthopaedic total knee tibial components using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This practice is only applicable to stresses below the yield strength, as provided in the material certification. 1.2 Purpose— This practice establishes requirements and considerations for the development of finite element models to be used in the evaluation of metallic orthopaedic total knee tibial component designs for the purpose of prediction of the static implant stresses and strains. This procedure can be used for worst-case assessment within a series of different implant sizes of the same implant design to reduce the physical test burden. Recommended procedures for performing model checks and verification are provided as an aid to determine if the analysis follows recommended guidelines. Finally, the recommended content of an engineering report covering the mechanical simulation is presented. 1.3 Limits— This practice is limited in discussion to the static structural analysis of metallic orthopaedic total knee tibial components (which excludes the prediction of fatigue strength). 1.4 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. 1.5 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 is applicable to the calculation of stresses seen on a knee tibial component when loaded in a manner described in this practice. This practice can be used to identify the worst-case size for a particular implant. When stresses calculated using this FEA method were compared to the stresses measured at two locations on the tibial tray using physical strain gauging techniques performed at one laboratory, the difference observed was -6.8 % at one location (with the strain gauges reporting the higher stress) and 3.1 % at the other location (with the FEA method reporting a higher stress). This difference should be considered when determining the worst-case size(s) of the same implant design. 3.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial component designs, when tested under similar conditions.