ASTM F3738-25
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Summary
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.
Significance and Use:
4.1 This test method is designed to rank and/or compare polyethylene liner materials and/or designs in metal-on-polyethylene hip prostheses under simulated physiological conditions with third-body particles in the joint space. Results can also be compared to pristine (clean) wear data and/or reference implant bearing materials (per ISO 21535:2023, Section 3.13).
4.2 In this test, particles are embedded into each polyethylene liner to mimic Mode 3 conditions; subsequently, wear testing is performed in a hip joint simulator in accordance with ISO 14242-1 or ISO 14242-3.
4.2.1 During the execution of the test, embedded particles can become dislodged from the polyethylene surface, migrate, and become re-embedded or ejected into the surrounding circulating test fluid.
4.2.2 The embedding of third-body particles within a polyethylene liner in this method is unlikely to confound the mass loss of the specimen due to the relatively greater mass loss of polyethylene in comparison to the mass of the embedded third-body debris. The mass loss measurements and subsequent wear analysis can be used to gauge the severity and wear performance of the bearing couple.
4.2.3 Qualitative evaluations, such as microscopic and high-magnification imaging, may provide additional insight on the wear behavior of the bearing couple, identify wear features and mechanisms (e.g., adhesive wear, abrasive wear), and failure modes (e.g., break-up or delamination, including surface cracking or fracture of the articulating surfaces).
4.2.4 Dual-mobility total hip replacements and characterization of femoral heads are outside of the scope of this standard test method.
Technical characteristics
| Publisher | American Society for Testing and Materials (ASTM International) |
| Publication Date | 06/01/2025 |
| Collection | |
| Page Count | 5 |
| Themes | Aids and adaptation for moving |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |