1. Scope

1.1 This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this standard contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup ('hip-type') wear, delamination wear, etc.). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.

1.2 All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D883 Terminology Relating to Plastics

F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

G40 Terminology Relating to Wear and Erosion

Keywords

joint prosthesis materials; pin-on-disk; wear testing; Fixed-bearing ball-cup wear applications; Hip replacement prosthesis; Hip-type wear test; Delamination; Joint prostheses; Laboratory testing; Linear reciprocating wear motion; Nominally linear motion delamination/wear test; Pin-on-disk evaluation method; Plastic surgical devices/applications; Polymers (surgical applications); Testing methods--surgical implants; Wear testing--surgical implant materials/applications;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0732-00

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