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ASTM F3334-19

(Practice)

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components

SIGNIFICANCE AND USE
3.1 This practice is applicable to the calculation of stresses seen on a knee tibial component when loaded in a manner described in this practice. This practice can be used to identify the worst-case size for a particular implant. When stresses calculated using this FEA method were compared to the stresses measured at two locations on the tibial tray using physical strain gauging techniques performed at one laboratory, the difference observed was -6.8 % at one location (with the strain gauges reporting the higher stress) and 3.1 % at the other location (with the FEA method reporting a higher stress). This difference should be considered when determining the worst-case size(s) of the same implant design.  
3.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial component designs, when tested under similar conditions.
SCOPE
1.1 This practice establishes requirements and considerations for the numerical simulation of metallic orthopaedic total knee tibial components using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This practice 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 metallic orthopaedic total knee tibial 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 series of different implant sizes of the same implant design to reduce the physical test burden. Recommended procedures for performing model checks and verification are provided as an aid to 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 practice is limited in discussion to the static structural analysis of metallic orthopaedic total knee tibial components (which excludes the prediction of fatigue strength).  
1.4 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.  
1.5 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.

General Information

Status
Published
Publication Date
31-Jul-2019
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Refers
ASTM F1800-19 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Effective Date
01-Oct-2019
Refers
ASTM F1800-19e1 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Effective Date
01-Oct-2019

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ASTM F3334-19 - Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial ComponentsASTM F3334-19 - Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
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ASTM F3334-19 - Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
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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: F3334 − 19
Standard Practice for
Finite Element Analysis (FEA) of Metallic Orthopaedic Total
1
Knee Tibial Components
This standard is issued under the fixed designation F3334; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This practice establishes requirements and consider-
F1800Practice for Cyclic Fatigue Testing of Metal Tibial
ations for the numerical simulation of metallic orthopaedic
Tray Components of Total Knee Joint Replacements
total knee tibial components using Finite Element Analysis
(FEA) techniques for the estimation of stresses and strains.
3. Significance and Use
This practice is only applicable to stresses below the yield
strength, as provided in the material certification.
3.1 This practice is applicable to the calculation of stresses
seen on a knee tibial component when loaded in a manner
1.2 Purpose—This practice establishes requirements and
described in this practice.This practice can be used to identify
considerations for the development of finite element models to
the worst-case size for a particular implant. When stresses
be used in the evaluation of metallic orthopaedic total knee
calculated using this FEA method were compared to the
tibial component designs for the purpose of prediction of the
stresses measured at two locations on the tibial tray using
static implant stresses and strains. This procedure can be used
physical strain gauging techniques performed at one
for worst-case assessment within a series of different implant
laboratory, the difference observed was -6.8 % at one location
sizes of the same implant design to reduce the physical test
(withthestraingaugesreportingthehigherstress)and3.1%at
burden. Recommended procedures for performing model
the other location (with the FEA method reporting a higher
checks and verification are provided as an aid to determine if
stress).Thisdifferenceshouldbeconsideredwhendetermining
the analysis follows recommended guidelines. Finally, the
the worst-case size(s) of the same implant design.
recommended content of an engineering report covering the
3.2 Theloadingoftibialtraydesignsinvivowill,ingeneral,
mechanical simulation is presented.
differ from the loading defined in this practice. However, this
1.3 Limits—This practice is limited in discussion to the
practice is designed to allow for comparisons between the
static structural analysis of metallic orthopaedic total knee
fatigue performance of different metallic tibial component
tibial components (which excludes the prediction of fatigue
designs, when tested under similar conditions.
strength).
4. System Geometry
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4.1 Finite element models are based on a geometric repre-
responsibility of the user of this standard to establish appro-
sentation of the device being studied. The source of the
priate safety, health, and environmental practices and deter-
geometricdetailscanbeobtainedfromdrawings,solidmodels,
mine the applicability of regulatory limitations prior to use.
preliminary sketches, or any other source consistent with
defining the model geometry. In building the finite element
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard- model, certain geometric details may be omitted from the
orthopaedic implant geometry shown in the Computer Aided
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- Design (CAD) model if it is determined that they are not
relevant to the intended analysis. Engineering judgment shall
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. be exercised to establish the extent of geometric simplification
and shall be justified.
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
2
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.22 on Arthroplasty. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Aug. 1, 2019. Published September 2019. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3334-19. the ASTM website.
Copyright © ASTM International, 100 Barr
...

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4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
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A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
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Standard Guide for Total Knee Replacement Loading Profiles

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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off