ASTM F3140-23
(Test Method)Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
SIGNIFICANCE AND USE
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.
4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.
4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.
1.3 This test method may require modifications to accommodate other tibial tray designs.
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.
1.5 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.
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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: F3140 − 23
Standard Test Method for
Cyclic Fatigue Testing of Metal Tibial Tray Components of
1
Unicondylar Knee Joint Replacements
This standard is issued under the fixed designation F3140; 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 E467 Practice for Verification of Constant Amplitude Dy-
namic Forces in an Axial Fatigue Testing System
1.1 This test method covers a procedure for the fatigue
E468 Practice for Presentation of Constant Amplitude Fa-
testing of metallic tibial trays used in partial knee joint
tigue Test Results for Metallic Materials
replacements.
E739 Guide for Statistical Analysis of Linear or Linearized
1.2 This test method covers the procedures for the perfor-
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
mance of fatigue tests on metallic tibial components using a
E1823 Terminology Relating to Fatigue and Fracture Testing
cyclic, constant-amplitude force. It applies to tibial trays which
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
cover either the medial or the lateral plateau of the tibia.
Tray Components of Total Knee Joint Replacements
F2083 Specification for Knee Replacement Prosthesis
1.3 This test method may require modifications to accom-
modate other tibial tray designs.
3. Terminology
1.4 This test method is intended to provide useful,
3.1 Definitions:
consistent, and reproducible information about the fatigue
3.1.1 R value—the R value, also known as the force ratio, is
performance of metallic tibial trays with unsupported mid-
the ratio of the minimum load to the maximum load. See
section of the condyle.
Terminology E1823.
1.5 The values stated in SI units are to be regarded as
minimum load
standard. No other units of measurement are included in this
R 5 (1)
maximum load
standard.
3.2 Definitions of Terms Specific to This Standard:
1.6 This standard does not purport to address all of the
3.2.1 anteroposterior (A/P) centerline—a line that passes
safety concerns, if any, associated with its use. It is the
through the center of the tibial tray, parallel to the sagittal
responsibility of the user of this standard to establish appro-
plane, perpendicular to the line of load application, and which
priate safety, health, and environmental practices and deter-
1
is ⁄2 the maximum tibial tray width in the M/L direction.
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
3.2.2 distance, d —the perpendicular distance between the
ap
dance with internationally recognized principles on standard- mediolateral centerline of the tibia component and the point of
ization established in the Decision on Principles for the
load application.
Development of International Standards, Guides and Recom-
3.2.3 distance, d —the perpendicular distance from the
ml
mendations issued by the World Trade Organization Technical
anteroposterior centerline of the tibia component to the center
Barriers to Trade (TBT) Committee.
of the load application.
3.2.4 fixture centerline—a line that passes through the center
2. Referenced Documents
of the fixture, aligned with the anteroposterior centerline.
2
2.1 ASTM Standards:
3.2.5 mediolateral (M/L) centerline—a line that passes
through the center of the tibial tray, parallel to the coronal or
1
frontal plane, perpendicular to the line of load application, and
This test method is under the jurisdiction of ASTM Committee F04 on Medical
1
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
which is ⁄2 the maximum tibial tray length in the A/P direction.
F04.22 on Arthroplasty.
Current edition approved Sept. 1, 2023. Published September 2023. Originally
4. Significance and Use
approved in 2017. Last previous edition approved in 2017 as F3140 – 17. DOI:
10.1520/F3140-23.
4.1 This test method can be used to describe the effects of
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
materials, manufacturing, and design variables on the fatigue
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
performance of metallic tibial trays subject to cyclic loading
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. for relatively large numbers of cycles.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3140 − 17 F3140 − 23
Standard Test Method for
Cyclic Fatigue Testing of Metal Tibial Tray Components of
1
Unicondylar Knee Joint Replacements
This standard is issued under the fixed designation F3140; 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
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic,
constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.
1.3 This test method may require modifications to accommodate other tibial tray designs.
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of
metallic tibial trays with unsupported mid-section of the condyle.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
E739 Guide for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
E1823 Terminology Relating to Fatigue and Fracture Testing
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
F2083 Specification for Knee Replacement Prosthesis
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Sept. 1, 2017Sept. 1, 2023. Published October 2017September 2023. Originally approved in 2017. Last previous edition approved in 2017 as
F3140 – 17. DOI: 10.1520/F3140-17.10.1520/F3140-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3140 − 23
3. Terminology
3.1 Definitions:
3.1.1 R value—the R value, also known as the force ratio, is the ratio of the minimum load to the maximum load. See Terminology
E1823.
minimumload
R 5 (1)
maximumload
minimumload
R 5 (1)
maximumload
3.2 Definitions of Terms Specific to This Standard:
3.2.1 anteroposterior (A/P) centerline—a line that passes through the center of the tibial tray, parallel to the sagittal plane and
1
plane, perpendicular to the line of load application.application, and which is ⁄2 the maximum tibial tray width in the M/L direction.
3.2.2 distance, d —the perpendicular distance between the mediolateral centerline of the tibia component and the point of load
ap
application.
3.2.3 distance, d —the perpendicular distance from the anteroposterior centerline of the tibia component to the center of the load
ml
application.
3.2.4 fixture centerline—a line that passes through the center of the fixture, aligned with the anteroposterior centerline.
3.2.5 mediolateral (M/L) centerline—a line that passes through the center of the tibial tray, parallel to the coronal, or frontal, plane
1
and coronal or frontal plane, perpendicular to the line of load application. application, and which is ⁄2 the maximu
...
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