Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles

Importancia y uso:

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.

Subcomité:

F04.22

Volúmen:

13.02

Palabras clave:

adverse conditions; arthroplasty; hip joints; hip prostheses; hip simulator; hip simulator wear; hip wear; mode 3; polyethylene; third-body; third-body particles; wear; wear testing;