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ASTM F2118-03(2009)

Historical Reaffirmation

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

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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.

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).

SDO ASTM: ASTM International
Document Number F2118
Publication Date April 1, 2009
Language en - English
Page Count 8
Revision Level 03(2009)
Supercedes
Committee F04.15
Publish Date Document Id Type View
Dec. 1, 2014 F2118-14 Revision
Dec. 1, 2010 F2118-10 Revision
Sept. 10, 2003 F2118-03 Revision
Oct. 10, 2001 F2118-01A Revision
Oct. 10, 2001 F2118-01 Revision
Sept. 1, 2020 F2118-14R20 Reaffirmation
April 1, 2009 F2118-03R09 Reaffirmation