ASTM F2118-03(2009)
(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:
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.
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 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 F 451. 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. Furthermore, it is not the intention of this test method 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 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 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.
General Information
Relations
Buy Standard
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:F2118–03 (Reapproved 2009)
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 ISO7206-8 ImplantsforSurgery,PartialandTotalHipJoint
Prostheses, Part 8—Endurance Performance of Stemmed
1.1 This test method describes test procedures for evaluat-
3
Femoral Components with Application of Torsion
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 orthopaedic bone ce-
3.1 Unless otherwise given, the definitions for fatigue ter-
ments based on acrylic resins, as specified in Specification
minology given in Terminology E1823 will be used.
F451.Theproceduresinthistestmethodmayormaynotapply
3.2 median fatigue strength at N cycles—The maximum
to other surgical cement materials.
stress at which 50 % of the specimens of a given sample would
1.3 It is not the intention of this test method to define levels
be expected to survive N loading cycles. For the purposes of
of performance of these materials. Furthermore, it is not the
this test method, the fatigue strength will be determined at 5
intentionofthistestmethodtodirectlysimulatetheclinicaluse
million load cycles. A rationale for this is provided in the
of these materials.
Appendix X1.4.
1.4 A rationale is given in Appendix X1.
3.3 runout—Apredeterminednumberofcyclesatwhichthe
1.5 The values stated in SI units are to be regarded as
testing on a particular specimen will be stopped, and no further
standard. No other units of measurement are included in this
testingonthatspecimenwillbeperformed.Forthepurposesof
standard.
this test method, the runout will be 5 million load cycles.
1.6 This standard does not purport to address all of the
3.4 stress level—The value of stress at which a series of
safety concerns associated with its use. It is the responsibility
duplicate tests are performed. For the purposes of this test
oftheuserofthisstandardtoconsultandestablishappropriate
method, the stress level is reported as the maximum stress
safety and health practices and determine the applicability of
applied to the specimen.
regulatory limitations prior to use.
3.5 specimen failure—The condition at which the specimen
2. Referenced Documents completelybreaksorisdamagedtosuchanextentthattheload
2 frame is no longer able to apply the intended stress within the
2.1 ASTM Standards:
required limits.
E466 Practice for Conducting Force Controlled Constant
Amplitude Axial Fatigue Tests of Metallic Materials
4. Summary of Test Method
E467 Practice for Verification of Constant Amplitude Dy-
4.1 Uniformcylindricalreducedgagesectiontestspecimens
namic Forces in an Axial Fatigue Testing System
are manufactured from acrylic bone cement and mounted in a
E1823 Terminology Relating to Fatigue and Fracture Test-
uniaxial fatigue frame. The specimen is subjected to fully
ing
reversed tensile and compressive loading in a sinusoidal cyclic
F451 Specification for Acrylic Bone Cement
manner at a specified frequency in phosphate buffered saline
2.2 ISO Standard:
(PBS).Thefatigueloadingiscontinueduntilthespecimenfails
or a predetermined number of cycles (runout limit) is reached.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
5. Significance and Use
F04.15 on Material Test Methods.
5.1 This test method describes a uniaxial, constant ampli-
Current edition approved April 1, 2009. Published April 2009. Originally
approved in 2001. Last previous edition approved in 2003 as F2118 – 03. DOI: tude, fully reversed fatigue test to characterize the fatigue
10.1520/F2118-03R09.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. 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.
1
---------------------- Page: 1 ----------------------
F2118–03 (2009)
performance of a uniform cylindrical waisted specimen manu- 6. Apparatus
factured from acrylic bone cement.
6.1 Uniaxial Load Frame—A testing machine capable of
5.2
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2118–01a
Test Method for Designation:F2118–03 (Reapproved 2009)
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 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This standard test method describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression
uniform fatigue performance of acrylic bone cement materials.
1.2 This standard test method is relevant to orthopaedic bone cements based on acrylic resins, as specified in Specification
F 451. The procedures in this guide test method may or may not apply to other surgical cement materials.
1.3 It is not the intention of this standard test method to define levels of performance of these materials. Furthermore, it is not
the intention of this standardtest method to directly simulate the clinical use of these materials.
1.4 A rationale is given in Appendix X1.
1.5The values stated in SI units are to be regarded as the standard.
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 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:
E 466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
E 467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E 1823 Terminology Relating to Fatigue and Fracture Testing
F 451 Standard Specification for Acrylic Bone Cement
2.2 ISO Standard:
ISO 7206-8 Implants for Surgery, Partial andTotal Hip Joint Prostheses, Part 8—Endurance Performance of Stemmed Femoral
3
Components with Application of Torsion
3. Terminology Unless
3.1 Unless otherwise given, the definitions for fatigue terminology given in Terminology E 1823 will be used.
3.13.2 Median Fatigue Strengthmedian fatigue strength at N Cyclescycles—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 X1.4.
3.2Runout—A predetermined number of cycles at which the testing on a particular specimen will be stopped, and no further
testing on that specimen will be performed. For the purposes of this test method, the runout will be 5 million load cycles.
3.3 Stress Level—The value of stress at which a series of duplicate tests are performed. For the purposes of this method, the
stress level is reported as the maximum stress applied to the specimen. runout—A predetermined number of cycles at which the
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 October 10, 2001. Published November 2001. Originally published as F2118-01. Last previous edition F2118-01.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 2001. Last previous edition approved in 2003 as F2118 – 03.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 13.01.
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.
1
---------------------- Page: 1 ----------------------
F2118–03 (2009)
testing on a particular specimen will be stopped, and no further testing on that specimen will be performed. For the purposes of
this test method, the runout will be 5 million load cycles.
3.4 Specimen Failu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.