ASTM F1800-12
(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. This practice 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 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F1800 − 12
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 3. Terminology
3.1 Definitions:
1.1 This practice covers a procedure for the fatigue testing
of metallic tibial trays used in knee joint replacements. This 3.1.1 R value—TheRvalueistheratiooftheminimumload
to the maximum load.
practice covers the procedures for the performance of fatigue
tests on metallic tibial components using a cyclic, constant-
minimum load
R 5 (1)
amplitude force. It applies to tibial trays which cover both the
maximum load
medial and lateral plateaus of the tibia. This practice may
3.2 Definitions of Terms Specific to This Standard:
requiremodificationstoaccommodateothertibialtraydesigns.
3.2.1 anteroposterior centerline—a line that passes through
1.2 This practice is intended to provide useful, consistent,
the center of the tibial tray, parallel to the sagittal plane and
and reproducible information about the fatigue performance of
perpendicular to the line of load application. For asymmetric
metallic tibial trays with one unsupported condyle.
tibial tray designs, the appropriate center of the tibial tray shall
be determined by the investigator and the rationale reported.
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3.2.2 fixture centerline—alinethatpassesthroughthecenter
standard. of the fixture, parallel to the anteroposterior centerline. This
line represents the separation between the supported and
1.4 This standard does not purport to address all of the
unsupported portions of the test fixture.
safety concerns, if any, associated with its use. It is the
3.2.3 mediolateral centerline—alinethatpassesthroughthe
responsibility of the user of this standard to establish appro-
center of the tibial tray, parallel to the coronal, or frontal, plane
priate safety and health practices and determine the applica-
and perpendicular to the line of load application. For asym-
bility of regulatory limitations prior to use.
metric tibial tray designs, the appropriate center of the tibial
tray shall be determined by the investigator and the rationale
2. Referenced Documents
reported.
2
2.1 ASTM Standards:
3.2.4 moment arm, d —the perpendicular distance between
ap
E4 Practices for Force Verification of Testing Machines
the mediolateral centerline of the tibia component and the line
E467 Practice for Verification of Constant Amplitude Dy-
of load application.
namic Forces in an Axial Fatigue Testing System
3.2.5 moment arm, d —the perpendicular distance between
E468 Practice for Presentation of Constant Amplitude Fa-
ml
the anteroposterior centerline of the tibia component and the
tigue Test Results for Metallic Materials
line of load application.
E1150 Definitions of Terms Relating to Fatigue (Withdrawn
3
1996)
4. Significance and Use
4.1 This practice can be used to describe the effects of
materials, manufacturing, and design variables on the fatigue
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
performance of metallic tibial trays subject to cyclic loading
Surgical Materials and Devices and is the direct responsibility of Subcommittee
for relatively large numbers of cycles.
F04.22 on Arthroplasty.
Current edition approved Dec. 15, 2012. Published January 2013. Originally
4.2 Theloadingoftibialtraydesigns in vivowill,ingeneral,
approved in 1997. Last previous edition approved in 2007 as F1800 – 07. DOI:
differ from the loading defined in this practice. The results
10.1520/F1800-12.
2
obtained here cannot be used to directly predict in vivo
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
performance. However, this practice is designed to allow for
Standards volume information, refer to the standard’s Document Summary page on
comparisons between the fatigue performance of different
the ASTM website.
3
metallic tibial tray designs, when tested under similar condi-
The last approved version of this historical standard is referenced on
www.astm.org. tions.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1800 − 12
4.3 Inorderforfatiguedataontibialtraystobecomparable, the keel (see Fig. 2). The method of supporting (or not
reproducible, and capab
...
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 − 07 F1800 − 12
Standard Test Method 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 test method practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements.
This test method practice 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 both the medial and lateral plateaus of the tibia. This test method
practice may require modifications to accommodate other tibial tray designs.
1.2 This test method practice is intended to provide useful, consistent, and reproducible information about the fatigue
performance of metallic tibial trays with one unsupported condyle.
1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for
information only.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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
3
E1150 Definitions of Terms Relating to Fatigue (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
3.2 Definitions of Terms Specific to This Standard:
3.2.1 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.
3.2.2 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.
3.2.3 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.
1
This test method 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 Sept. 15, 2007Dec. 15, 2012. Published October 2007January 2013. Originally approved in 1997. Last previous edition approved in 20042007
as F1800 – 04.F1800 – 07. DOI: 10.1520/F1800-07.10.1520/F1800-12.
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.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1800 − 12
3.2.4 moment arm, d —the perpendicular distance between the mediolateral centerline of the tibia component and the line of
ap
load application.
3.2.5 moment arm, d —the perpendicular distance between the anteroposterior centerline of the tibia component and the line
ml
of load application.
4. Significance and Use
4.1 This test method 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 r
...
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