ASTM F1800-19e1
(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.
General Information
Relations
Standards Content (Sample)
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: 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
ε NOTE—Section 8.2 was corrected editorially in January 2020.
1. Scope E467 Practice for Verification of Constant Amplitude Dy-
namic Forces in an Axial Fatigue Testing System
1.1 This practice covers a procedure for the fatigue testing
E468 Practice for Presentation of Constant Amplitude Fa-
of metallic tibial trays used in knee joint replacements using a
tigue Test Results for Metallic Materials
cyclic, constant-amplitude force. It applies to tibial trays that
F2083 Specification for Knee Replacement Prosthesis
cover both the medial and lateral plateaus of the tibia. This
practicemayrequiremodificationstoaccommodateothertibial
3. Terminology
tray designs.
3.1 Definitions of Terms Specific to This Standard:
1.2 This practice is intended to provide useful, consistent,
3.1.1 anteroposterior centerline—line that passes through
and reproducible information about the fatigue performance of
the center of the tibial tray, parallel to the sagittal plane and
metallic tibial trays with one unsupported condyle. The results
perpendicular to the line of load application. For asymmetric
are applicable to the laboratory test conditions and may not
tibial tray designs, the appropriate center of the tibial tray shall
correlate with in vivo performance.
be determined by the investigator and the rationale reported.
1.3 The values stated in SI units are to be regarded as
3.1.2 fixture centerline—line that passes through the center
standard. No other units of measurement are included in this
of the fixture, parallel to the anteroposterior centerline. This
standard.
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
3.1.3 mediolateral centerline—line that passes through the
responsibility of the user of this standard to establish appro-
center of the tibial tray, parallel to the coronal, or frontal, plane
priate safety, health, and environmental practices and deter-
and perpendicular to the line of load application. For asym-
mine the applicability of regulatory limitations prior to use.
metric tibial tray designs, the appropriate center of the tibial
1.5 This international standard was developed in accor-
tray shall be determined by the investigator and the rationale
dance with internationally recognized principles on standard-
reported.
ization established in the Decision on Principles for the
3.1.4 moment arm, d —the perpendicular distance between
Development of International Standards, Guides and Recom-
ap
the mediolateral centerline of the tibia component and the line
mendations issued by the World Trade Organization Technical
of load application.
Barriers to Trade (TBT) Committee.
3.1.5 moment arm, d —the perpendicular distance between
ml
2. Referenced Documents
the anteroposterior centerline of the tibia component and the
2
2.1 ASTM Standards: line of load application.
E4 Practices for Force Verification of Testing Machines
4. Significance and Use
4.1 This practice can be used to describe the effects of
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
materials, manufacturing, and design variables on the fatigue
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
performance of metallic tibial trays subject to cyclic loading
Current edition approved Oct. 1, 2019. Published January 2020. Originally
for relatively large numbers of cycles.
approved in 1997. Last previous edition approved in 2012 as F1800–12. DOI:
10.1520/F1800-19E01.
4.2 Theloadingoftibialtraydesigns in vivowill,ingeneral,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
differ from the loading defined in this practice. The results
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
obtained here cannot be used to directly predict in-vivo
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. performance. However, this practice is designed to allow for
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.