ASTM F2118-10

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:
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 can plotted on an S-N diagram.
Another approach is to determine the fatigue life of a particular cement. The fatigue life for orthopaedic bone cement is to be determined up to 5 million (5 × 106) cycles.  
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 involves multiple factors. 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, anatomical site, and patient factors, among others. This test method does not specifically address all of 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 test method describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform fatigue performance of acrylic bone cement materials.
1.2 This test method is relevant to orthopedic bone cements based on acrylic resins, as specified in Specification F451 and ISO 16402. The procedures in this test method may or may not apply to other surgical cement materials.
1.3 It is not the intention of this test method to define levels of performance of these materials. It is not the intention of this test method to directly simulate the clinical use of these materials, but rather to allow for comparison between acrylic bone cements to evaluate fatigue behavior under specified conditions.
1.4 A rationale is given in Appendix X2.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.

General Information

• Status: Historical
• Publication Date: 30-Nov-2010
• ICS: 91.100.10 - Cement. Gypsum. Lime. Mortar
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F2118-03(2009) - Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
• Effective Date: 01-Dec-2010

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: F2118 − 10
StandardTest Method for
Constant Amplitude of Force Controlled Fatigue Testing of
1
Acrylic Bone Cement Materials
This standard is issued under the fixed designation F2118; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 ISO Standard:
ISO 16402Flexural Fatigue Testing of Acrylic Resin Ce-
1.1 This test method describes test procedures for evaluat-
3
ments Used in Orthopedics
ing the constant amplitude, uniaxial, tension-compression uni-
form fatigue performance of acrylic bone cement materials.
3. Terminology
1.2 This test method is relevant to orthopedic bone cements
3.1 Unless otherwise given, the definitions for fatigue ter-
based on acrylic resins, as specified in Specification F451 and
minology given in Terminology E1823 will be used.
ISO16402.Theproceduresinthistestmethodmayormaynot
apply to other surgical cement materials. 3.2 Definitions:
3.2.1 mean fatigue life at N cycles—the average number of
1.3 It is not the intention of this test method to define levels
cycles to failure at the specified load level. For the purposes of
of performance of these materials. It is not the intention of this
thistestmethod,thefatiguelifewillbedeterminedat5million
test method to directly simulate the clinical use of these
load cycles. A rationale for this is provided in X2.4.
materials, but rather to allow for comparison between acrylic
3.2.2 median fatigue life at a given stress level—thenumber
bone cements to evaluate fatigue behavior under specified
of cycles to failure at which 50% of the tested samples failed
conditions.
at the specified stress level.
1.4 A rationale is given in Appendix X2.
3.2.3 runout—a predetermined number of cycles at which
1.5 The values stated in SI units are to be regarded as
the testing on a particular specimen will be stopped, and no
standard. No other units of measurement are included in this
further testing on that specimen will be performed. For the
standard.
purposes of this test method, the runout will be 5 million load
1.6 This standard does not purport to address all of the
cycles.
safety concerns, if any, associated with its use. It is the
3.2.4 specimenfailure—theconditionatwhichthespecimen
responsibility of the user of this standard to establish appro-
completelybreaksorisdamagedtosuchanextentthattheload
priate safety and health practices and determine the applica-
frame is no longer able to apply the intended stress within the
bility of regulatory limitations prior to use.
required limits.
3.2.5 stress level—the value of stress at which a series of
2. Referenced Documents
duplicate tests are performed. For the purposes of this test
2
2.1 ASTM Standards:
method, the stress level is reported as the maximum stress
E466Practice for Conducting Force Controlled Constant
applied to the specimen.
Amplitude Axial Fatigue Tests of Metallic Materials
E467Practice for Verification of Constant Amplitude Dy-
4. Summary of Test Method
namic Forces in an Axial Fatigue Testing System
4.1 Uniformcylindricalreducedgagesectiontestspecimens
E1823TerminologyRelatingtoFatigueandFractureTesting
are manufactured from acrylic bone cement and mounted in a
F451Specification for Acrylic Bone Cement
uniaxial fatigue frame. The specimen is subjected to fully
reversed tensile and compressive loading in a sinusoidal cyclic
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
manner at a specified frequency in phosphate buffered saline
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
(PBS).Thefatigueloadingiscontinueduntilthespecimenfails
F04.15 on Material Test Methods.
Current edition approved Dec. 1, 2010. Published January 2011. Originally orapredeterminednumberofcycles(run-outlimit)isreached.
approved in 2001. Last previous edition approved in 2009 as F2118–03(2009).
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2118 − 10
5. Significance and Use 7. Test Specimen
5.1 This test method describes a uniaxial, constant 7.1 Test specimens shall be fabricated from cement that is
amplitude,fullyreversedfatiguetesttocharacterizethefatigue
representat
...

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:F2118–03 (Reapproved 2009) Designation:F2118–10
Standard Test Method for
Constant Amplitude of Force Controlled Fatigue Testing of
1
Acrylic Bone Cement Materials
This standard is issued under the fixed designation F2118; 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 describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform
fatigue performance of acrylic bone cement materials.
1.2 This test method is relevant to orthopaedic bone cements based on acrylic resins, as specified in Specification F451 and ISO
16402. The procedures in this test method may or may not apply to other surgical cement materials.
1.3It is not the intention of this test method to define levels of performance of these materials. Furthermore, it is not the intention
of this test method to directly simulate the clinical use of these materials.
1.4A rationale is given in Appendix X1
1.3 It is not the intention of this test method to define levels of performance of these materials. It is not the intention of this
testmethodtodirectlysimulatetheclinicaluseofthesematerials,butrathertoallowforcomparisonbetweenacrylicbonecements
to evaluate fatigue behavior under specified conditions.
1.4 A rationale is given in Appendix X2.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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 consult and establish appropriate safety and health practices and determine the applicability of
regulatory limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E1823 Terminology Relating to Fatigue and Fracture Testing
F451 Specification for Acrylic Bone Cement
2.2 ISO Standard:
ISO 7206-8Implants for Surgery, Partial and Total Hip Joint Prostheses, Part 8—Endurance Performance of Stemmed Femoral
3
Components withApplication ofTorsionISO 16402 Flexural FatigueTesting ofAcrylic Resin Cements Used in Orthopedics
3. Terminology
3.1 Unless otherwise given, the definitions for fatigue terminology given in Terminology E1823 will be used.
3.2median fatigue strength at N cycles—The maximum stress at which 50% of the specimens of a given sample would be
expected to survive N loading cycles. For the purposes of this test method, the fatigue strength will be determined at 5 million load
cycles. A rationale for this is provided in the Appendix X1.4will be used.
3.1.1 mean fatigue life at N cycles—the average number of cycles to failure at the specified load level. For the purposes of this
test method, the fatigue life will be determined at 5 million load cycles. A rationale for this is provided in X2.4.
3.3
3.1.2 median fatigue life at a given stress level—the number of cycles to failure at which 50 % of the tested samples failed at
the specified stress level.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 2001. Last previous edition approved in 2003 as F2118–03. DOI:
10.1520/F2118-03R09.
Current edition approved Dec. 1, 2010. Published January 2011. Originally approved in 2001. Last previous edition approved in 2009 as F 2118 – 03 (2009).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2118–10
3.1.3 runout—Apredetermined number of cycles at wh
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