ASTM F1440-92(2002)

Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion

SIGNIFICANCE AND USE
This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue resistance of metallic stemmed femoral components subjected to cyclic loading for relatively large numbers of cycles. The recommended test assumes a “worst case‘‘ situation where proximal support for the stem has been lost. It is also recognized that for some materials the environment may have an effect on the response to cyclic loading. The test environment used and the rationale for the choice of that environment should be described in the report.
It is recognized that actual in vivo loading conditions are not constant amplitude. However, there is not sufficient information available to crate standard load spectrums for metallic stemmed femoral components. Accordingly, a simple periodic constant amplitude force is recommended.
In order for fatigue data on femoral stems to be useful for comparison, it must be reproducible among different laboratories. Consequently, it is essential that uniform procedures be established.
SCOPE
1.1 This practice describes a method for the fatigue testing of metallic stemmed femoral components used in hip arthroplasty. The described method is intended to be used to evaluate the comparison of various designs and materials used for stemmed femoral components used in the arthroplasty. This practice covers procedures for the performance of fatigue tests using (as a forcing function) a periodic constant amplitude force.
1.2 This practice applies primarily to one-piece prostheses and modular components, with head in place such that prostheses should not have an anterior/posterior bow, and should have a nearly straight section on the distal 50 mm of the stem. This practice may require modifications to accommodate other femoral stem designs.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 For additional information see Refs. (1-5) .

General Information

• Status: Historical
• Publication Date: 14-Sep-1992
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Replaces: ASTM F1440-92(1997) - Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
• Effective Date: 15-Sep-1992
• Replaced By: ASTM F1440-92(2008) - Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion (Withdrawn 2012)
• Effective Date: 01-Jun-2008
• Referred By: ASTM F1875-98(2022) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
• Effective Date: 15-Sep-1992

Standards Content (Sample)

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:F1440–92(Reapproved 2002)
Standard Practice for
Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty
1
Femoral Components Without Torsion
This standard is issued under the fixed designation F 1440; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice describes a method for the fatigue testing
of metallic stemmed femoral components used in hip arthro-
plasty.The described method is intended to be used to evaluate
the comparison of various designs and materials used for
stemmed femoral components used in the arthroplasty. This
practice covers procedures for the performance of fatigue tests
using (as a forcing function) a periodic constant amplitude
force.
1.2 This practice applies primarily to one-piece prostheses
and modular components, with head in place such that pros-
theses should not have an anterior/posterior bow, and should
have a nearly straight section on the distal 50 mm of the stem.
This practice may require modifications to accommodate other
femoral stem designs.
1.3 The values stated in SI units are to be regarded as the
standard.
1.4 For additional information see Refs. (1-5) .
2. Referenced Documents
2.1 ASTM Standards:
2
E 4 Practices for Force Verification of Testing Machines
E 466 Practice for Conducting Force Controlled Constant
2
Amplitude Axial Fatigue Tests of Metallic Materials
E 467 Practice for Verification of Constant Amplitude Dy-
FIG. 1 Collared Device
2
namic Forces in an Axial Fatigue Testing System
E 468 Practice for Presentation of Constant Amplitude Fa-
2
tigue Test Results for Metallic Materials
3.1.4 geometric centroid (cantilever plane)— the point in a
cross-sectional area of the cantilever plane whose coordinates
3. Terminology
are the mean values of the coordinates of all the points in the
3.1 Definitions and Symbols (see Fig. 1(a) and 1(b)):
area.
3.1.1 cantilever plane—a plane perpendicular to the line of
3.1.5 line of load application—the loading axis of the test
load application at the level on the stem where the stem
machine.
becomes unsupported.
3.1.6 Reference Line L1, distal stem axis—the medial-
3.1.2 distal stem axis—the centerline in the anterior/
lateral(M-L)centerlineofthemostdistal50mmofsteminthe
posterior projection of the most distal 50 mm of the stem.
A-P projection.
3.1.3 estimated maximum bending moment—the maximum
3.1.7 Reference Line L2:
load times the unloaded moment arm.
3.1.7.1 collared device— the plane of the distal side of the
collar in the A-P projection.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3.1.7.2 collarless device—theresectionplanerecommended
Surgical Materials and Devices and is the direct responsibility of Subcommittee
for the device in the A-P projection.
F04.22 on Arthroplasty.
Current edition approved Sept. 15, 1992. Published November 1992.
2
Annual Book of ASTM Standards, Vol 03.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F1440–92 (2002)
3.1.8 Reference Point P1—the spherical center of the pros-
thesis head.
3.1.9 Reference Point P3:
3.1.9.1 collared device— the intersection of the principal
axisofthecollar(L2)withthemedialsurfaceofthesteminthe
A-P projection.
3.1.9.2 collarless device—the intersection of the resection
plane (L2) with the medial surface of the stem in the A-P
projection.
3.1.10 Reference Point P4—the distal tip of the stem.
3
3.1.11 Reference Point P6 — the intersection of the canti-
lever plane with the medial surface of the stem in the A-P
projection.
3.1.12 R value—the R value is the ratio of the minimum
force to the maximum force.
minimum force
R 5
maximum force
3.1.13 Stem ReferenceAngle X—theanglebetweenthestem
reference line and the line of load application.
3.1.14 stem reference line—a line passing through Refer-
ence Point P6 and the center of the prosthesis head (P1).
3.1.15 supported stem length—the vertical distance be-
FIG. 2 Collarless Device
tween the distal tip of the stem (P4) and the cantilever plane.
3.1.16 unloaded moment arm—the perpendicular distance
5. Specimen Selection
between the line of load application and the geometric centroid
5.1 The specimen selection should have the same geometry
of the stem cross section at the cantilever plane.
as the final finished product, and the stem should be in the final
3.1.17 unsupported stem length—the vertical distance be-
finished condition.
tween Point P3 and the cantilever plane.
3.2 See Figs. 1 and 2.
6. Apparatus
6.1 Thespecimenshallbeconstrained
...