ASTM F3161-2016 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions《在封闭条件下对金属骨科全膝关节股骨组件进行有限元分析 (FE.pdf
《ASTM F3161-2016 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions《在封闭条件下对金属骨科全膝关节股骨组件进行有限元分析 (FE.pdf》由会员分享,可在线阅读,更多相关《ASTM F3161-2016 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions《在封闭条件下对金属骨科全膝关节股骨组件进行有限元分析 (FE.pdf(7页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F3161 16Standard Test Method forFinite Element Analysis (FEA) of Metallic Orthopaedic TotalKnee Femoral Components under Closing Conditions1This standard is issued under the fixed designation F3161; the number immediately following the designation indicates the year oforiginal adoption
2、or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This standard establishes requirements and consider-ations for the numerical
3、simulation of metallic orthopaediccemented and cementless total knee femoral components usingFinite ElementAnalysis (FEA) techniques for the estimation ofstresses and strains. This standard is only applicable to stressesbelow the yield strength, as provided in the material certifica-tion.1.2 Purpose
4、This test method establishes requirements andconsiderations for the development of finite element models tobe used in the evaluation of metallic orthopaedic total kneefemoral component designs for the purpose of prediction of thestatic implant stresses and strains. This procedure can be usedfor wors
5、t-case assessment within a family of implant sizes toprovide efficiencies in the amount of physical testing to beconducted. Recommended procedures for performing modelchecks and verification are provided to help determine if theanalysis follows recommended guidelines. Finally, the recom-mended conte
6、nt of an engineering report covering the mechani-cal simulation is presented.1.3 LimitsThis document is limited in discussion to thestatic structural analysis of metallic orthopaedic total kneefemoral components (which excludes the prediction of fatiguestrength).1.4 The values stated in SI units are
7、 to be regarded asstandard. No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices
8、and determine the applica-bility of regulatory limitations prior to use.2. Significance and Use2.1 This standard is applicable to the calculation of stressesseen on a knee femoral component when loaded in a mannerdescribed in this test method. This method can be used toestablish the worst-case size
9、for a particular implant family.When stresses calculated using this method were compared tothe stresses measured from physical strain gauging techniquesperformed at one laboratory, the results correlated to within9%.3. Geometric Data3.1 Finite element models are based on a geometric repre-sentation
10、of the device being studied. The source of thegeometric details can be obtained from drawings, solid models,preliminary sketches, or any other source consistent withdefining the model geometry. In building the finite elementmodel, certain geometric details may be omitted from theorthopaedic implant
11、geometry shown in the Computer AidedDesign (CAD) model if it is determined that they are notrelevant to the intended analysis. Engineering judgment shallbe exercised to establish the extent of model simplification andshall be justified.3.2 It is most appropriate to consider the worst-case stresscond
12、ition for the orthopaedic implant family being simulated.The worst-case shall be determined from all relevant engineer-ing considerations, such as femoral component geometry anddimensions. If finite element analysis is being used for deter-mining the worst-case, then the worst-case size may not bekn
13、own. It may be necessary to run several sizes in order todetermine the worst-case. If the FEA results do not conclu-sively determine the worst-case configuration, a rationaleshould be included (e.g., additional analysis or physical test-ing) to justify the worst-case size.4. Material Properties4.1 T
14、he required material properties for input into an FEAmodel for the calculation of strains and displacement aremodulus of elasticity (E) and Poissons ratio (). These valuescan typically be obtained from material certification data. Itshould be noted that the fatigue test is run under load control;the
15、 FEA should also be run under load control. When the FEAis run under load control, the modulus of elasticity will notaffect the stress calculations under small displacement theorybut will affect displacement and strain. The influence ofPoissons ratio on the stress calculations is negligible.1This te
16、st method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Feb. 1, 2016. Published March 2016. DOI: 10.1520/F316116Copyright ASTM International, 100 Barr Harbor
17、 Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.2 Ensure that material property units are consistent withgeometric units in the CAD model. SI units are the preferredunits of measurement.5. Loading5.1 The loading location and orientation of the knee femoralcomponent shall be gu
18、ided by the loading location andboundary conditions described below. The areas of particularinterest are the stresses at the posterior aspect of the condyle,anterior notch, and other design-specific critical regions.5.2 The worst-case condyle shall be loaded. If the weakercondyle cannot be justified
19、, each condyle shall be analyzedindividually. Centrally locate a 7.62 mm diameter projectedcircle over the apex of the posterior articulating surface withthe knee femoral component positioned in 90 degrees offlexion. Apply an anterior directed 1 N load uniformly over theface generated by the interse
20、ction of this projected circle withthe articulating surface. Refer to Fig. 1 and Fig. 2.NOTE 1Do not introduce additional solid material to the femoralcomponent model.NOTE 2It is recognized that the loading conditions in this test methodwill not be identical to those of a physical testing standard c
21、urrently underdevelopment. However, the differences in loading conditions (e.g., loadapplication differences; potting level differences; use of bone cementwhich is not modeled in FEA) do not significantly affect identification ofthe worst-case stress condition and construct for subsequent bench test
22、ing,which is the primary objective of this test method.5.3 Ensure that load units are consistent with materialproperty units.6. Boundary Conditions6.1 The prescribed boundary condition idealizes embeddingthe anterior flange within a potting medium. The femoralcomponent shall be fixed in all translat
23、ions on all “embedded”anterior flange surfaces. Refer to Fig. 1 and Fig. 3.Ahorizontalplane shall be constructed to define a closed perimeter aroundthe anterior flange periphery. Note that the horizontal planemay not be parallel to the anterior flange bone cut face. The useof other stress evaluation
24、 levels and/or constraint levels shallbe justified.7. Analysis7.1 The analysis and modeling system, programs or soft-ware used for the finite element model creation and analysisshould be capable of fully developing the geometric featuresand idealizing the loading and boundary condition environmentof
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