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Significance and Use
3.1 This practice is applicable to the calculation of stresses seen on a femoral hip stem when loaded in a manner described in ISO 7206-4 (2010). This method can be used to establish the worst case size for a particular implant. When stresses calculated using this practice were compared to the stresses measured from physical strain gauging techniques performed at two laboratories using two different methods, the results correlated to within 8 %.
1.1 This practice establishes requirements and considerations for the numerical simulation of non-modular (that is, limited to monolithic stems with only a femoral head / trunnion taper interface) metallic orthopaedic hip stems 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 practice establishes requirements and considerations for the development of finite element models to be used in the evaluation of non-modular metallic orthopaedic hip stem 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO7206-4(2010) Implants for Surgery--Partial and Total Hip Joint Prostheses--Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42320000(Orthopedic surgical implants)