F3738 (version 25)

1.1 This test method describes a laboratory method for evaluating the wear performance of metal-on-polyethylene hip joint prostheses under adverse conditions using third-body particles (simulated Mode 3 wear conditions).2 Procedures for particle selection and preparation, test setup, particle embedding, wear testing, and reporting requirements are described. Dual-mobility total hip replacements and characterization of femoral heads are outside of the scope of this standard test method.

1.2 This test method aims to provide an understanding of performance between differing implant designs and materials under the controlled introduction of reproducible and well-characterized third-body particles. While this method creates testing conditions and component damage more severe than that typically observed clinically, it is intended to provide a uniform methodology for evaluating relative differences in in vitro Mode 3 wear performance.

1.3 The intent of this test method is to quantitatively and qualitatively rank the materials and designs of polyethylene liners in metal-on-polyethylene bearing couples by evaluating mass change, wear mechanisms, and resulting damage arising from simulated Mode 3 wear conditions. The quantitative methods recommended herein may be used with consideration of the limitations arising from this test method. See Appendix X1 for further details on the rationale for including quantitative methods in addition to qualitative data.

1.4 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.

1.5 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.