ASTM F2118-03
(Test Method)Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
SIGNIFICANCE AND USE
This test method describes a uniaxial, constant amplitude, fully reversed fatigue test to characterize the fatigue performance of a uniform cylindrical waisted specimen manufactured from acrylic bone cement.
This test method considers two approaches to evaluating the fatigue performance of bone cement:
5.2.1 Testing is conducted at three stress levels to characterize the general fatigue behavior of a cement over a range of stresses. The stress level and resultant cycles to failure of the specimens are plotted on an S-N diagram.
5.2.2 Another approach is to determine the fatigue strength of a particular cement. The fatigue strength for orthopaedic bone cement is to be determined at 5 million (5 × 106) cycles. The “two-point method” is the specified procedure for conducting fatigue testing to determine fatigue strength [1].
This test method does not define or suggest required levels of performance of bone cement. This fatigue test method is not intended to represent the clinical use of orthopaedic bone cement, but rather to characterize the material using standard and well-established methods. The user is cautioned to consider the appropriateness of this test method in view of the material being tested and its potential application.
It is widely reported that multiple clinical factors affect the fatigue performance of orthopaedic bone cement; however, the actual mechanisms involved are not well understood. Clinical factors which may affect the performance of bone cement include: temperature and humidity, mixing method, time of application, surgical technique, bone preparation, implant design, and patient factors, among others. This test method does not specifically address these clinical factors. The test method can be used to compare different acrylic bone cement formulations and products and different mixing methods and environments (that is, mixing temperature, vacuum, centrifugation, and so forth).
SCOPE
1.1 This standard describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform fatigue performance of acrylic bone cement materials.
1.2 This standard is relevant to orthopaedic bone cements based on acrylic resins, as specified in Specification F451. The procedures in this guide may or may not apply to other surgical cement materials.
1.3 It is not the intention of this standard to define levels of performance of these materials. Furthermore, it is not the intention of this standard to directly simulate the clinical use of these materials.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as the standard.
1.6 This standard does not purport to address all of the safety concerns associated with its use. It is the responsibility of the user of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F2118–03
Standard Test Method for
Constant Amplitude of Force Controlled Fatigue Testing of
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Acrylic Bone Cement Materials
This standard is issued under the fixed designation F 2118; 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.
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1. Scope Femoral Components with Application of Torsion
1.1 This test method describes test procedures for evaluat-
3. Terminology
ing the constant amplitude, uniaxial, tension-compression uni-
3.1 Unless otherwise given, the definitions for fatigue ter-
form fatigue performance of acrylic bone cement materials.
minology given in Terminology E 1823 will be used.
1.2 This test method is relevant to orthopaedic bone ce-
3.2 median fatigue strength at N cycles—The maximum
ments based on acrylic resins, as specified in Specification
stress at which 50 % of the specimens of a given sample would
F 451. The procedures in this test method may or may not
be expected to survive N loading cycles. For the purposes of
apply to other surgical cement materials.
this test method, the fatigue strength will be determined at 5
1.3 It is not the intention of this test method to define levels
million load cycles. A rationale for this is provided in the
of performance of these materials. Furthermore, it is not the
Appendix X1.4.
intentionofthistestmethodtodirectlysimulatetheclinicaluse
3.3 runout—Apredeterminednumberofcyclesatwhichthe
of these materials.
testing on a particular specimen will be stopped, and no further
1.4 A rationale is given in Appendix X1.
testingonthatspecimenwillbeperformed.Forthepurposesof
1.5 The values stated in SI units are to be regarded as the
this test method, the runout will be 5 million load cycles.
standard.
3.4 stress level—The value of stress at which a series of
1.6 This standard does not purport to address all of the
duplicate tests are performed. For the purposes of this test
safety concerns associated with its use. It is the responsibility
method, the stress level is reported as the maximum stress
oftheuserofthisstandardtoconsultandestablishappropriate
applied to the specimen.
safety and health practices and determine the applicability of
3.5 specimen failure—The condition at which the specimen
regulatory limitations prior to use.
completelybreaksorisdamagedtosuchanextentthattheload
2. Referenced Documents frame is no longer able to apply the intended stress within the
required limits.
2.1 ASTM Standards:
E 466 Practice for Conducting Force Controlled Constant
4. Summary of Test Method
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Amplitude Axial Fatigue Tests of Metallic Materials
4.1 Uniformcylindricalreducedgagesectiontestspecimens
E 467 Practice for Verification of Constant Amplitude Dy-
2 are manufactured from acrylic bone cement and mounted in a
namic Forces in an Axial Fatigue Testing System
uniaxial fatigue frame. The specimen is subjected to fully
E 1823 Terminology Relating to Fatigue and Fracture Test-
2 reversed tensile and compressive loading in a sinusoidal cyclic
ing
3 manner at a specified frequency in phosphate buffered saline
F 451 Standard Specification for Acrylic Bone Cement
(PBS).Thefatigueloadingiscontinueduntilthespecimenfails
2.2 ISO Standard:
or a predetermined number of cycles (runout limit) is reached.
ISO7206-8 ImplantsforSurgery,PartialandTotalHipJoint
Prostheses, Part 8—Endurance Performance of Stemmed
5. Significance and Use
5.1 This test method describes a uniaxial, constant ampli-
tude, fully reversed fatigue test to characterize the fatigue
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
performance of a uniform cylindrical waisted specimen manu-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
factured from acrylic bone cement.
F04.15 on Material Test Methods.
Current edition approved Sept. 10, 2003. Published October 2003. Originally
approved in 2001. Last previous edition approved in 2001 as F2118 - 01a.
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Annual Book of ASTM Standards, Vol 03.01. AvailablefromAmericanNationalStandardsInstitute,25W.43rdSt,4thFloor,
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Annual Book of ASTM Standards, Vol 13.01. New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2118–03
5.2 Thistestmethodconsiderstwoapproachestoevaluating E 466. The alignment should be checked at both the maximum
the fatigue performance of bone cement: tensileandminimumcompressiveloadtobeappliedduringthe
5.2.1 Testing is conducted at three stress levels to charac- course of a test program.
terize the general fatigue behavior of a ceme
...
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