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ASTM F3210M-22

(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
Historical
Publication Date
14-Mar-2022
ICS
11.180.10 - Aids and adaptation for moving
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

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ASTM F3210M-22 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing ConditionsASTM F3210M-22 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
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ASTM F3210M-22 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F3210M −22
Standard Test Method for
Fatigue Testing of Total Knee Femoral Components Under
1
Closing Conditions
This standard is issued under the fixed designation F3210M; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This standard applies to metallic total knee femoral
components used in total knee arthroplasty (TKA). Femoral
2. Referenced Documents
components made of nonmetallic materials (for example,
2
2.1 ASTM Standards:
ceramic, polymer) could possibly be evaluated using this test
E4 Practices for Force Calibration and Verification of Test-
method. However, such materials may include risks of new
ing Machines
failure mechanisms which are not considered in this test
E467 Practice for Verification of Constant Amplitude Dy-
method.
namic Forces in an Axial Fatigue Testing System
1.2 The procedure described in this standard is performed
E468 Practice for Presentation of Constant Amplitude Fa-
ontotalkneefemoralcomponentsforsupportingdetermination
tigue Test Results for Metallic Materials
of fatigue behavior under closing-style loading conditions.
E739 PracticeforStatisticalAnalysisofLinearorLinearized
Closing-style loading refers to forces that act to reduce the
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
femoral intercondylar depth, resulting in a tensile stress on the
E1823 TerminologyRelatingtoFatigueandFractureTesting
articular surface of the femoral condyle. (See 3.2.2.)
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
Tray Components of Total Knee Joint Replacements
1.3 Differentdesignscanbecharacterizedas,butnotlimited
F2083 Specification for Knee Replacement Prosthesis
to, posterior cruciate ligament retaining (CR), posterior stabi-
F3140 Test Method for Cyclic Fatigue Testing of Metal
lizing (PS), and revision.
Tibial Tray Components of Unicondylar Knee Joint Re-
1.4 This standard does not address evaluation of femoral
placements
components under opening-style loading conditions which
F3161 Test Method for Finite Element Analysis (FEA) of
have also generated clinical failures. Under opening-style
Metallic Orthopaedic Total Knee Femoral Components
loading conditions, forces are applied to the inner contour of
under Closing Conditions
the femoral component in a way that the forces act to increase
3
2.2 ISO Standards:
the intercondylar depth, or open the femoral component.
ISO 5833 Implants for Surgery—Acrylic Resin Cements
1.5 Units—The values stated in SI units are to be regarded
ISO 7207-1 Implants for Surgery—Components for Partial
as standard. No other units of measurement are included in this
and Total Knee Joint Prostheses—Part 1: Classification,
standard.
Definitions and Designation of Dimensions
1.6 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Definitions:
responsibility of the user of this standard to establish appro-
3.1.1 femoral intercondylar depth—distance between the
priate safety, health, and environmental practices and deter-
anterior and posterior internal surfaces of the femoral
mine the applicability of regulatory limitations prior to use.
component, as defined in ISO 7207-1 and shown in Fig. 1(a).
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard- 3.1.2 total knee femoral component—a component of a total
ization established in the Decision on Principles for the knee joint prosthesis intended to be secured to the femur to
Development of International Standards, Guides and Recom- replace its articulating surfaces.
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/F3210M-22. 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 ----------------------
F3210M−22
FIG. 1Terminology and Test Configuration
3.2 Definitions of T
...

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5.1 The significance of the information to be recorded in a test report allows for exoskeleton safety and performance to be contextualized with the exoskeleton user. Exoskeleton test results can be compared across users to determine exoskeleton usefulness, exoskeleton capability for particular users or groups of users, and standardized reporting of user information allows organizations to better replicate tests.  
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5.3 Additional user measurement information may be found in the following references:
Note 1: The measurements in these references may not consider measurements of the user when dressed in appropriate clothing (for example, shoes – see 6.3.12 – 6.3.14) that will be worn when using an exoskeleton.  
5.3.1 2012 Anthropometric Survey (ANSUR II6) of U.S. Army Personnel: Methods and Summary Statistics,  
5.3.2 United States Air Force Research Laboratory Civilian American and European Surface Anthropometry Resource (CAESAR7) Final Report,  
5.3.3 Tables D6240/D6240M,  
5.3.4 Tables D8077/D8077M,  
5.3.5 Tables D7878/D7878M,  
5.3.6 Tables D6960/D6960M,  
5.3.7 Terminology D5219,  
5.3.8 Tables D8241/D8241M,  
5.3.9 Practice E3003,  
5.3.10 Practice F1731, and  
5.3.11 ISO 7250-1.
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1.1.2 Exoskeletons shall possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational.  
1.1.3 Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to traverse beams, as intended by the user or test requestor, while using an exoskeleton, is essential for exoskeleton deployment for a variety of tasks (for example, ascending/descending stairs, ramps, hills). This test method specifies test setup, procedure, and recording to standardize this beams task for testing exoskeleton user movement.  
1.1.4 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing, traversing gaps, hurdles, stairs, beams, slopes, various types of floor surfaces or terrains, or confined spaces, or combinations thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements.  
1.1.5 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods for evaluating exoskeleton capability requirements. This beams test method is a part of the test suite. The setup, procedure,...

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ASTM
ASTM F3581-22(Test Method)
Standard Test Method for Exoskeleton Use: Hurdles

SIGNIFICANCE AND USE
5.1 Hurdle designs can vary greatly in, for example: hurdle geometry, surface coatings, and coverings for a variety of industries. Fig. 1 shows examples of various hurdles.  
5.2 Exoskeletons are being used in the industrial/occupational, military, response, medical, and recreational sectors to enhance safety and effectiveness of the user to perform tasks. Hurdles are used in many tasks performed and may include, for example, upper, lower, or full body movement in order to complete the task. For example, an exoskeleton may be used to help rehabilitate a patient who suffered a traumatic injury. And in manufacturing, warehousing, and other occupations, and other similar environments, workers in exoskeletons may traverse hurdles (for example, obstacles) in the walkways while carrying or not carrying loads, indoors or outdoors, as part of their daily activities. The testing results of exoskeletons shall describe, in a statistically significant way, how reliably the exoskeleton is able to support tasks within the specified types of environments, confinements, and terrains, and thus provide sufficiently high levels of confidence to determine the applicability of the exoskeleton.  
5.3 This test method addresses exoskeleton safety and performance requirements expressed by manufacturing, emergency responders, military, or other organizations requesting this test. The safety and performance data captured within this test method are indicative of the test exoskeleton’s and the exoskeleton user’s capabilities. Having available direct information from tested exoskeleton(s) with associated performance data to guide procurement and deployment decisions is essential to exoskeleton purchasers and users.  
5.4 The testing results of the candidate exoskeleton(s) shall describe, in a statistically significant way, how reliably the exoskeleton user is able to negotiate hurdles. The test apparatus described in Section 6 is intended to be a single or set of hurdles where repeatable re...
SCOPE
1.1 Purpose:  
1.1.1 The purpose of this test method, as a part of a suite of exoskeleton use test methods, is to quantitatively evaluate an exoskeleton’s (see Terminology F3323) safety (see 1.4) or performance, or both, for traversing hurdles.  
1.1.2 Exoskeletons possess a certain set of allowable exoskeleton user movement capabilities, including user-motion adaptability, to suit operations such as: industrial/occupational, military, response, medical, or recreational. Environments in these typical sectors often pose constraints to exoskeleton user movement to various degrees. Being able to traverse hurdles, as intended by the user or test requestor, while using an exoskeleton is essential for exoskeleton deployment for a variety of tasks (for example, traversing logs, objects). This test method specifies test setup, procedure, and recording to standardize this hurdles task for testing exoskeleton user movement.  
1.1.3 Exoskeletons need to function as intended, regardless of types of tasks and terrain complexities (for example, carpet, metal, masonry, rock, wood). Required movement capabilities may include, for example: walking, running, crawling, climbing, traversing gaps, hurdles, stairs, slopes, various types of floor surfaces or terrains, or confined spaces, or any combination thereof. Standard test methods are required to evaluate whether or not exoskeletons meet these requirements.  
1.1.4 ASTM Subcommittee F48.03 develops and maintains international standards for task performance and environmental considerations that include but are not limited to, standards for safety, quality, and efficiency. This subcommittee aims to develop standards for any exoskeleton application as exemplified as in 1.1.2. The F48.03 test suite consists of a set of test methods for evaluating exoskeleton capability requirements. This hurdles test method is a part of the test suite. The setup, procedure, and apparatuses associated wi...

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