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ASTM F3210-22e1

(Test Method)

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions

SIGNIFICANCE AND USE
5.1 Clinical fractures of total knee femoral components have been observed and reported in the literature (1-12).4 (See X1.4.)  
5.2 This test method provides a procedure to perform fatigue testing on total knee femoral components under closing conditions caused by an unsupported condyle that result in a tensile stress on the articular surface and a compressive stress on the interior, beveled surfaces.  
5.3 This test method is intended to evaluate the fatigue performance of knee femoral components under a simulated articulation loading condition. The load acts to move the posterior femoral condyle toward the anterior flange.  
5.4 This test method simulates a clinically severe condition in which all bony support is lost and one condyle is supporting the complete load at the knee joint at 90° of tibiofemoral flexion.  
5.5 Testing in accordance with this test method typically produces regions of high tensile stress in the intercondylar notch and on the articular surface where the anterior flange transitions to condyle.  
5.6 The loading of total knee femoral components using this test method may differ from actual in vivo loading conditions. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparison between the fatigue performance of different total knee femoral component designs when tested under similar closing conditions.
SCOPE
1.1 This standard applies to metallic total knee femoral components used in total knee arthroplasty (TKA). Femoral components made of nonmetallic materials (for example, ceramic, polymer) could possibly be evaluated using this test method. However, such materials may include risks of new failure mechanisms which are not considered in this test method.  
1.2 The procedure described in this standard is performed on total knee femoral components for supporting determination of fatigue behavior under closing-style loading conditions. Closing-style loading refers to forces that act to reduce the femoral intercondylar depth, resulting in a tensile stress on the articular surface of the femoral condyle. (See 3.2.2.)  
1.3 Different designs can be characterized as, but not limited to, posterior cruciate ligament retaining (CR), posterior stabilizing (PS), and revision.  
1.4 This standard does not address evaluation of femoral components under opening-style loading conditions which have also generated clinical failures. Under opening-style loading conditions, forces are applied to the inner contour of the femoral component in a way that the forces act to increase the intercondylar depth, or open the femoral component.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

General Information

Status
Published
Publication Date
14-Mar-2022
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 E1823-20 - Standard Terminology Relating to Fatigue and Fracture Testing
Effective Date
01-Feb-2020

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ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing ConditionsASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
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ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
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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.
´1
Designation: F3210 −22
Standard Test Method for
Fatigue Testing of Total Knee Femoral Components Under
1
Closing Conditions
This standard is issued under the fixed designation F3210; 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
ε NOTE—The designation was updated editorially in March 2022.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This standard applies to metallic total knee femoral
mendations issued by the World Trade Organization Technical
components used in total knee arthroplasty (TKA). Femoral
Barriers to Trade (TBT) Committee.
components made of nonmetallic materials (for example,
ceramic, polymer) could possibly be evaluated using this test
2. Referenced Documents
method. However, such materials may include risks of new
2
failure mechanisms which are not considered in this test 2.1 ASTM Standards:
method. E4 Practices for Force Calibration and Verification of Test-
ing Machines
1.2 The procedure described in this standard is performed
E467 Practice for Verification of Constant Amplitude Dy-
ontotalkneefemoralcomponentsforsupportingdetermination
namic Forces in an Axial Fatigue Testing System
of fatigue behavior under closing-style loading conditions.
E468 Practice for Presentation of Constant Amplitude Fa-
Closing-style loading refers to forces that act to reduce the
tigue Test Results for Metallic Materials
femoral intercondylar depth, resulting in a tensile stress on the
E739 PracticeforStatisticalAnalysisofLinearorLinearized
articular surface of the femoral condyle. (See 3.2.2.)
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
1.3 Differentdesignscanbecharacterizedas,butnotlimited
E1823 TerminologyRelatingtoFatigueandFractureTesting
to, posterior cruciate ligament retaining (CR), posterior stabi-
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
lizing (PS), and revision.
Tray Components of Total Knee Joint Replacements
F2083 Specification for Knee Replacement Prosthesis
1.4 This standard does not address evaluation of femoral
components under opening-style loading conditions which F3140 Test Method for Cyclic Fatigue Testing of Metal
Tibial Tray Components of Unicondylar Knee Joint Re-
have also generated clinical failures. Under opening-style
loading conditions, forces are applied to the inner contour of placements
F3161 Test Method for Finite Element Analysis (FEA) of
the femoral component in a way that the forces act to increase
the intercondylar depth, or open the femoral component. Metallic Orthopaedic Total Knee Femoral Components
under Closing Conditions
1.5 Units—The values stated in SI units are to be regarded
3
2.2 ISO Standards:
as standard. No other units of measurement are included in this
ISO 5833 Implants for Surgery—Acrylic Resin Cements
standard.
ISO 7207-1 Implants for Surgery—Components for Partial
1.6 This standard does not purport to address all of the
and Total Knee Joint Prostheses—Part 1: Classification,
safety concerns, if any, associated with its use. It is the
Definitions and Designation of Dimensions
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor- 3.1 Definitions:
dance with internationally recognized principles on standard-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.22 on Arthroplasty. the ASTM website.
3
Current edition approved March 15, 2022. Published March 2022. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F3210-22E01. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
F3210 − 22
3.1.1 femoral intercondylar depth—distance between the 4. Summary of Test Method
anterior and posterior internal surfaces of the femoral
4.1 This method p
...

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1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
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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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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
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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.
SCOPE
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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off