1.1This test method describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform fatigue performance of acrylic bone cement materials.
1.2This 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.
1.3It 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.
1.4A rationale is given in Appendix X2.
1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6This 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.
1.7This 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.