【国外标准】 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

2.1 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 family. 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%.1.1 This standard establishes requirements and considerations for the numerical simulation of metallic orthopaedic cemented and cementless total knee femoral components 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 metallic orthopaedic total knee femoral 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 family of implant sizes to provide efficiencies in the amount of physical testing to be conducted. 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 document 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 and health practices and determine the applicability of regulatory limitations prior to use.