ASTM F2118-14(2020)

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

SIGNIFICANCE AND USE
5.1 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.  
5.2 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 can be plotted on an S-N diagram.  
5.2.2 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.  
5.3 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.  
5.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Aug-2020
• 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

• Refers: ASTM E1823-20 - Standard Terminology Relating to Fatigue and Fracture Testing
• Effective Date: 01-Feb-2020

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2118 − 14 (Reapproved 2020)
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 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. Referenced Documents
2
2.1 ASTM Standards:
1.1 This test method describes test procedures for evaluat-
D412TestMethodsforVulcanizedRubberandThermoplas-
ing the constant amplitude, uniaxial, tension-compression uni-
tic Elastomers—Tension
form fatigue performance of acrylic bone cement materials.
D792Test Methods for Density and Specific Gravity (Rela-
1.2 This test method is relevant to orthopedic bone cements
tive Density) of Plastics by Displacement
based on acrylic resins, as specified in Specification F451 and
D1084Test Methods for Viscosity of Adhesives
ISO16402.Theproceduresinthistestmethodmayormaynot
D2090Test Method for Clarity and Cleanness of Paint and
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apply to other surgical cement materials.
Ink Liquids (Withdrawn 2007)
D2196Test Methods for Rheological Properties of Non-
1.3 It is not the intention of this test method to define levels
Newtonian Materials by Rotational Viscometer
of performance of these materials. It is not the intention of this
D2240Test Method for Rubber Property—Durometer Hard-
test method to directly simulate the clinical use of these
ness
materials, but rather to allow for comparison between acrylic
E466Practice for Conducting Force Controlled Constant
bone cements to evaluate fatigue behavior under specified
Amplitude Axial Fatigue Tests of Metallic Materials
conditions.
E467Practice for Verification of Constant Amplitude Dy-
1.4 A rationale is given in Appendix X2. namic Forces in an Axial Fatigue Testing System
E1823TerminologyRelatingtoFatigueandFractureTesting
1.5 The values stated in SI units are to be regarded as
F451Specification for Acrylic Bone Cement
standard. No other units of measurement are included in this
2.2 ISO Standard:
standard.
ISO 16402Flexural Fatigue Testing of Acrylic Resin Ce-
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1.6 This standard does not purport to address all of the
ments Used in Orthopedics
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3.1 Unless otherwise given, the definitions for fatigue ter-
mine the applicability of regulatory limitations prior to use.
minology given in Terminology E1823 will be used.
1.7 This international standard was developed in accor-
3.2 Definitions:
dance with internationally recognized principles on standard-
3.2.1 mean fatigue life at N cycles—the average number of
ization established in the Decision on Principles for the
cycles to failure at the specified load level. For the purposes of
Development of International Standards, Guides and Recom-
thistestmethod,thefatiguelifewillbedeterminedat5million
mendations issued by the World Trade Organization Technical
load cycles. A rationale for this is provided in X2.4.
Barriers to Trade (TBT) Committee.
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
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ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical Standards volume information, refer to the standard’s Document Summary page on
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee the ASTM website.
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F04.15 on Material Test Methods. The last approved version of this historical standard is referenced on
Current edition approved Sept. 1, 2020. Published September 2020. Originally www.astm.org.
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approved in 2001. Last previous edition approved in 2014 as F2118–14. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI:10.1520/F2118-14R20. 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 − 14 (2020)
3.2.2 median fatigue life at a given stress level—thenumber mixing methods and environments (that is, mixing
of cycles to failure at which 50% of the tested samples failed temperature, vacuum, centrifugation, and so forth).
at the specified stress level.
6. Apparatus
3.2.3 runout—a predetermined number of cycles at which
the testing on a particular sp
...