1.1. This test method describes a laboratory method for evaluating the wear performance of metal-on-polymer hip joint prostheses under adverse conditions using third-body abrasive particles. Considerations for in vivo sources of third-body particles are provided to aid the user in particle material selection, followed by a test method containing general procedures for particle production, test setup, and particle application.
1.2. The intent of this test method is to quantitatively and qualitatively determine and characterize wear, and any atypical wear mechanisms and resulting damage arising from simulated abrasive conditions. The quantitative methods recommended herein may be used with consideration of the limitations arising from this test method. This method may also be used to determine material ranking, or to perform side-by-side comparisons of prostheses designs under harsher tribological and physiological conditions in the human joint; therefore, testing should be performed in an appropriate joint simulator apparatus.
Arthroplasty; tribology; wear testing; mode 3 wear; particles; wear; adverse testing; adverse wear; third body particles; third-body particles; third body particle wear testing; joint arthroplasty; joint simulator; wear simulator; hip joint simulator; hip simulator
This standard is needed in order to produce comparable wear results under standardized third body (adverse) conditions. These comparisons will be important for regulatory submission and review for the purposes of gaining medical device clearance. The standard will be used by engineers, R&D scientists, independent laboratories, and OEM manufacturers.
The title and scope are in draft form and are under development within this