ASTM F3161-16
(Test Method)Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
SIGNIFICANCE AND USE
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%.
SCOPE
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.
General Information
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Standards Content (Sample)
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.
Designation: F3161 − 16
Standard Test Method for
Finite Element Analysis (FEA) of Metallic Orthopaedic Total
1
Knee Femoral Components under Closing Conditions
This standard is issued under the fixed designation F3161; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope described in this test method. This method can be used to
establish the worst-case size for a particular implant family.
1.1 This standard establishes requirements and consider-
When stresses calculated using this method were compared to
ations for the numerical simulation of metallic orthopaedic
the stresses measured from physical strain gauging techniques
cemented and cementless total knee femoral components using
performed at one laboratory, the results correlated to within
FiniteElementAnalysis(FEA)techniquesfortheestimationof
9%.
stresses and strains. This standard is only applicable to stresses
below the yield strength, as provided in the material certifica-
3. Geometric Data
tion.
3.1 Finite element models are based on a geometric repre-
1.2 Purpose—Thistestmethodestablishesrequirementsand
sentation of the device being studied. The source of the
considerations for the development of finite element models to
geometricdetailscanbeobtainedfromdrawings,solidmodels,
be used in the evaluation of metallic orthopaedic total knee
preliminary sketches, or any other source consistent with
femoral component designs for the purpose of prediction of the
defining the model geometry. In building the finite element
static implant stresses and strains. This procedure can be used
model, certain geometric details may be omitted from the
for worst-case assessment within a family of implant sizes to
orthopaedic implant geometry shown in the Computer Aided
provide efficiencies in the amount of physical testing to be
Design (CAD) model if it is determined that they are not
conducted. Recommended procedures for performing model
relevant to the intended analysis. Engineering judgment shall
checks and verification are provided to help determine if the
be exercised to establish the extent of model simplification and
analysis follows recommended guidelines. Finally, the recom-
shall be justified.
mendedcontentofanengineeringreportcoveringthemechani-
3.2 It is most appropriate to consider the worst-case stress
cal simulation is presented.
condition for the orthopaedic implant family being simulated.
1.3 Limits—This document is limited in discussion to the
The worst-case shall be determined from all relevant engineer-
static structural analysis of metallic orthopaedic total knee
ing considerations, such as femoral component geometry and
femoral components (which excludes the prediction of fatigue
dimensions. If finite element analysis is being used for deter-
strength).
mining the worst-case, then the worst-case size may not be
1.4 The values stated in SI units are to be regarded as
known. It may be necessary to run several sizes in order to
standard. No other units of measurement are included in this
determine the worst-case. If the FEA results do not conclu-
standard.
sively determine the worst-case configuration, a rationale
1.5 This standard does not purport to address all of the should be included (e.g., additional analysis or physical test-
safety concerns, if any, associated with its use. It is the ing) to justify the worst-case size.
responsibility of the user of this standard to establish appro-
4. Material Properties
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4.1 The required material properties for input into an FEA
model for the calculation of strains and displacement are
2. Significance and Use
modulus of elasticity (E) and Poisson’s ratio (ν). These values
2.1 This standard is applicable to the calculation of stresses
can typically be obtained from material certification data. It
seen on a knee femoral component when loaded in a manner
should be noted that the fatigue test is run under load control;
the FEAshould also be run under load control. When the FEA
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
is run under load control, the modulus of elasticity will not
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
affect the stress calculations under small displacement theory
F04.22 on Arthroplasty.
but will affect displacement and strain. The influence of
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