ASTM F3140-17

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F3140 − 17
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 E739 Practice for Statistical Analysis of Linear or Linearized
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
1.1 This test method covers a procedure for the fatigue
E1823 Terminology Relating to Fatigue and Fracture Testing
testing of metallic tibial trays used in partial knee joint
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
replacements.
Tray Components of Total Knee Joint Replacements
1.2 This test method covers the procedures for the perfor-
F2083 Specification for Knee Replacement Prosthesis
mance of fatigue tests on metallic tibial components using a
cyclic, constant-amplitude force. It applies to tibial trays which
3. Terminology
cover either the medial or the lateral plateau of the tibia.
3.1 Definitions:
1.3 This test method may require modifications to accom-
3.1.1 R value—the R value, also known as the force ratio, is
modate other tibial tray designs.
the ratio of the minimum load to the maximum load. See
1.4 This test method is intended to provide useful,
Terminology E1823.
consistent, and reproducible information about the fatigue
minimum load
performance of metallic tibial trays with unsupported mid-
R 5 (1)
maximum load
section of the condyle.
3.2 Definitions of Terms Specific to This Standard:
1.5 The values stated in SI units are to be regarded as
3.2.1 anteroposterior (A/P) centerline—a line that passes
standard. No other units of measurement are included in this
through the center of the tibial tray, parallel to the sagittal plane
standard.
and perpendicular to the line of load application.
1.6 This standard does not purport to address all of the
3.2.2 fixture centerline—a line that passes through the center
safety concerns, if any, associated with its use. It is the
of the fixture, aligned with the anteroposterior centerline.
responsibility of the user of this standard to establish appro-
priate safety, health and environmental practices and deter-
3.2.3 mediolateral (M/L) centerline—a line that passes
mine the applicability of regulatory limitations prior to use.
through the center of the tibial tray, parallel to the coronal, or
1.7 This international standard was developed in accor-
frontal, plane and perpendicular to the line of load application.
dance with internationally recognized principles on standard-
3.2.4 distance, d —the perpendicular distance between the
ap
ization established in the Decision on Principles for the
mediolateral centerline of the tibia component and the point of
Development of International Standards, Guides and Recom-
load application.
mendations issued by the World Trade Organization Technical
3.2.5 distance, d —the perpendicular distance from the
Barriers to Trade (TBT) Committee.
ml
anteroposterior centerline of the tibia component to the center
2. Referenced Documents
of the load application.
2.1 ASTM Standards:
4. Significance and Use
E467 Practice for Verification of Constant Amplitude Dy-
namic Forces in an Axial Fatigue Testing System
4.1 This test method can be used to describe the effects of
E468 Practice for Presentation of Constant Amplitude Fa-
materials, manufacturing, and design variables on the fatigue
tigue Test Results for Metallic Materials
performance of metallic tibial trays subject to cyclic loading
for relatively large numbers of cycles.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
4.2 The loading of tibial tray designs in vivo will, in general,
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
differ from the loading defined in this practice. The results
F04.22 on Arthroplasty.
obtained here cannot be used to directly predict in vivo
Current edition approved Sept. 1, 2017. Published October 2017. DOI: 10.1520/
F3140-17. performance. However, this practice is designed to allow for
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3140 − 17
comparisons between the fatigue performance of different prevent a possible rotation or spit-out of the implant during the
metallic tibial tray designs, when tested under similar condi- relatively high frequency fatigue test. Friction between the
tions. implant and the walls should be minimized.
6.1.1 The implant shall be pl
...