ASTM F2118-01a

Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

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.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• 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 F2118-01 - Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
• Effective Date: 10-Oct-2001
• Replaced By: ASTM F2118-03 - Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
• Effective Date: 10-Sep-2003

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2118 – 01a
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.
1. Scope 3. Terminology
Unless otherwise given, the definitions for fatigue
1.1 This standard describes test procedures for evaluating
terminology given in Terminology E 1823 will be used.
the constant amplitude, uniaxial, tension-compression uniform
fatigue performance of acrylic bone cement materials. 3.1 Median Fatigue Strength at N Cycles—The maximum
1.2 This standard is relevant to orthopaedic bone cements stress at which 50 % of the specimens of a given sample would
based on acrylic resins, as specified in Specification F 451. The be expected to survive N loading cycles. For the purposes of
procedures in this guide may or may not apply to other surgical this test method, the fatigue strength will be determined at 5
cement materials. million load cycles. A rationale for this is provided in the
1.3 It is not the intention of this standard to define levels of Appendix X1.4.
performance of these materials. Furthermore, it is not the 3.2 Runout—A predetermined number of cycles at which
intention of this standard to directly simulate the clinical use of the testing on a particular specimen will be stopped, and no
these materials. further testing on that specimen will be performed. For the
1.4 A rationale is given in Appendix X1. purposes of this test method, the runout will be 5 million load
1.5 The values stated in SI units are to be regarded as the cycles.
standard. 3.3 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 method,
safety concerns associated with its use. It is the responsibility the stress level is reported as the maximum stress applied to the
of the user of this standard to consult and establish appropriate specimen.
safety and health practices and determine the applicability of 3.4 Specimen Failure—The condition at which the speci-
regulatory limitations prior to use. men completely breaks or is damaged to such an extent that the
load frame is no longer able to apply the intended stress within
2. Referenced Documents
the required limits.
2.1 ASTM Standards:
4. Summary of Test Method
E 466 Practice for Conducting Force Controlled Constant
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Amplitude Axial Fatigue Tests of Metallic Materials 4.1 Uniform cylindrical reduced gage section test specimens
E 467 Practice for Verification of Constant Amplitude Dy- are manufactured from acrylic bone cement and mounted in a
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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- reversed tensile and compressive loading in a sinusoidal cyclic
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ing manner at a specified frequency in phosphate buffered saline
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F 451 Standard Specification for Acrylic Bone Cement (PBS). The fatigue loading is continued until the specimen fails
2.2 ISO Standard: or a predetermined number of cycles (runout limit) is reached.
ISO 7206-8 Implants for Surgery, Partial and Total Hip Joint
5. Significance and Use
Prostheses, Part 8—Endurance Performance of Stemmed
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5.1 This test method describes a uniaxial, constant ampli-
Femoral Components with Application of Torsion
tude, fully reversed fatigue test to characterize the fatigue
performance of a uniform cylindrical waisted specimen manu-
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This test method is under the jurisdiction of ASTM Committee F04 on Medical
factured from acrylic bone cement.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.2 This method considers two approaches to evaluating the
F04.15 on Material Test Methods.
fatigue performance of bone cement:
Current edition approved October 10, 2001. Published November 2001. Origi-
nally published as F2118 - 01. Last previous edition F2118 - 01. 5.2.1 Testing is conducted at three stress levels to charac-
2
Annual Book of ASTM Standards, Vol 03.01.
terize the general fatigue behavior of a cement over a range of
3
Annual Book of ASTM Standards, Vol 13.01.
stresses. The stress level and resultant cycles to failure of the
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Available from American National Standards Institute, 25 W. 43rd St, 4th Floor,
specimens are plotted on an S-N diagram.
New York, NY 10036.
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