scope:

This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.

This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.

Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.

This test method applies to bearing components manufactured from UHMWPE.

This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.

The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.

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.