ASTM F1800-19
(Practice)Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
SIGNIFICANCE AND USE
4.1 This practice 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 practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements using a cyclic, constant-amplitude force. It applies to tibial trays that cover both the medial and lateral plateaus of the tibia. This practice may require modifications to accommodate other tibial tray designs.
1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with one unsupported condyle. The results are applicable to the laboratory test conditions and may not correlate with in vivo performance.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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Designation: F1800 − 19
Standard Practice for
Cyclic Fatigue Testing of Metal Tibial Tray Components of
1
Total Knee Joint Replacements
This standard is issued under the fixed designation F1800; 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 E468 Practice for Presentation of Constant Amplitude Fa-
tigue Test Results for Metallic Materials
1.1 This practice covers a procedure for the fatigue testing
F2083 Specification for Knee Replacement Prosthesis
of metallic tibial trays used in knee joint replacements using a
cyclic, constant-amplitude force. It applies to tibial trays that
3. Terminology
cover both the medial and lateral plateaus of the tibia. This
practicemayrequiremodificationstoaccommodateothertibial
3.1 Definitions of Terms Specific to This Standard:
tray designs.
3.1.1 anteroposterior centerline—line that passes through
the center of the tibial tray, parallel to the sagittal plane and
1.2 This practice is intended to provide useful, consistent,
perpendicular to the line of load application. For asymmetric
and reproducible information about the fatigue performance of
tibial tray designs, the appropriate center of the tibial tray shall
metallic tibial trays with one unsupported condyle. The results
be determined by the investigator and the rationale reported.
are applicable to the laboratory test conditions and may not
correlate with in vivo performance.
3.1.2 fixture centerline—line that passes through the center
of the fixture, parallel to the anteroposterior centerline. This
1.3 The values stated in SI units are to be regarded as
line represents the separation between the supported and
standard. No other units of measurement are included in this
unsupported portions of the test fixture.
standard.
3.1.3 mediolateral centerline—line that passes through the
1.4 This standard does not purport to address all of the
center of the tibial tray, parallel to the coronal, or frontal, plane
safety concerns, if any, associated with its use. It is the
and perpendicular to the line of load application. For asym-
responsibility of the user of this standard to establish appro-
metric tibial tray designs, the appropriate center of the tibial
priate safety, health, and environmental practices and deter-
tray shall be determined by the investigator and the rationale
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor- reported.
dance with internationally recognized principles on standard-
3.1.4 moment arm, d —the perpendicular distance between
ap
ization established in the Decision on Principles for the
the mediolateral centerline of the tibia component and the line
Development of International Standards, Guides and Recom-
of load application.
mendations issued by the World Trade Organization Technical
3.1.5 moment arm, d —the perpendicular distance between
ml
Barriers to Trade (TBT) Committee.
the anteroposterior centerline of the tibia component and the
line of load application.
2. Referenced Documents
2
2.1 ASTM Standards:
4. Significance and Use
E4 Practices for Force Verification of Testing Machines
E467 Practice for Verification of Constant Amplitude Dy-
4.1 This practice can be used to describe the effects of
namic Forces in an Axial Fatigue Testing System
materials, manufacturing, and design variables on the fatigue
performance of metallic tibial trays subject to cyclic loading
for relatively large numbers of cycles.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
4.2 Theloadingoftibialtraydesigns in vivowill,ingeneral,
F04.22 on Arthroplasty.
differ from the loading defined in this practice. The results
Current edition approved Oct. 1, 2019. Published November 2019. Originally
obtained here cannot be used to directly predict in-vivo
approved in 1997. Last previous edition approved in 2012 as F1800–12. DOI:
10.1520/F1800-19.
performance. However, this practice is designed to allow for
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
comparisons between the fatigue performance of different
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
metallic tibial tray designs, when tested under similar condi-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. tions.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1800 − 19
4.3
...
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: F1800 − 12 F1800 − 19
Standard Practice for
Cyclic Fatigue Testing of Metal Tibial Tray Components of
1
Total Knee Joint Replacements
This standard is issued under the fixed designation F1800; 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 practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements. This practice
covers the procedures for the performance of fatigue tests on metallic tibial components replacements using a cyclic,
constant-amplitude force. It applies to tibial trays whichthat cover both the medial and lateral plateaus of the tibia. This practice
may require modifications to accommodate other tibial tray designs.
1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of
metallic tibial trays with one unsupported condyle. The results are applicable to the laboratory test conditions and may not correlate
with in vivo performance.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
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
E1150F2083 Definitions of Terms Relating to FatigueSpecification for Knee Replacement Prosthesis (Withdrawn 1996)
3. Terminology
3.1 Definitions:
3.1.1 R value—The R value is the ratio of the minimum load to the maximum load.
minimum load
R 5 (1)
maximum load
3.1 Definitions of Terms Specific to This Standard:
3.1.1 anteroposterior centerline—a line that passes through the center of the tibial tray, parallel to the sagittal plane and
perpendicular to the line of load application. For asymmetric tibial tray designs, the appropriate center of the tibial tray shall be
determined by the investigator and the rationale reported.
3.1.2 fixture centerline—a line that passes through the center of the fixture, parallel to the anteroposterior centerline. This line
represents the separation between the supported and unsupported portions of the test fixture.
1
This practice 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 Dec. 15, 2012Oct. 1, 2019. Published January 2013November 2019. Originally approved in 1997. Last previous edition approved in 20072012
as F1800 – 07.F1800–12. DOI: 10.1520/F1800-12.10.1520/F1800-19.
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 ----------------------
F1800 − 19
3.1.3 mediolateral centerline—a line that passes through the center of the tibial tray, parallel to the coronal, or frontal, plane
and perpendicular to the line of load application. For asymmetric tibial tray designs, the appropriate center of the tibial tray shall
be determined by the investigator and the rationale reported.
3.1.4 moment arm, d —the perpendicular distance between the mediolateral centerline of the tibia component and the line of
ap
load application.
3.1.5 moment arm, d —the perpendicular distance between the anteroposterior c
...
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