1.1 本标准规定了在闭合条件下使用有限元分析（FEA）技术对金属骨科骨水泥和非骨水泥全膝股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。本标准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-- 本试验方法确定了有限元模型开发的要求和考虑因素，用于评估非模块化金属骨科全膝股骨组件设计，以预测静态植入物应力和应变。 使用背景是应用有限元法来识别同一植入物设计的一系列不同尺寸中的最坏尺寸，并随后测试该最坏尺寸（通常需要）。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导方针。最后，介绍了涵盖机械仿真的工程报告的推荐内容。 1.3 限制-- 该测试方法仅限于讨论金属骨科全膝股骨组件的静态结构分析（不包括疲劳强度的预测）。 1.4 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、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====== 3.1 本标准适用于计算以本试验方法所述方式加载时膝股骨组件上的应力。这种方法可用于确定特定植入物的最坏情况尺寸。当使用这种方法计算的应力与在一个实验室进行的物理应变测量技术测量的应力进行比较时，结果的相关性在9%以内。

1.1 This standard establishes requirements and considerations for the numerical simulation of metallic orthopaedic cemented and cementless total knee femoral components under closing conditions using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This standard is only applicable to stresses below the yield strength, as provided in the material certification. 1.2 Purpose— This test method establishes requirements and considerations for the development of finite element models to be used in the evaluation of non-modular metallic orthopaedic total knee femoral component designs for the purpose of prediction of the static implant stresses and strains. The context of use is to apply the finite element method to identify the worst-case size within a series of different sizes of the same implant design and to subsequently test that worst-case size (as is typically required). Recommended procedures for performing model checks and verification are provided to help 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 test method is limited in discussion to the static structural analysis of metallic orthopaedic total knee femoral components (which excludes the prediction of fatigue strength). 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 ====== 3.1 This standard is applicable to the calculation of stresses seen on a knee femoral component when loaded in a manner described in this test method. This method can be used to establish the worst-case size for a particular implant. When stresses calculated using this method were compared to the stresses measured from physical strain gauging techniques performed at one laboratory, the results correlated to within 9 %.