Full Description

1.1This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur.

1.2This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined.

1.3This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.

Note 1:Devices for custom applications are not covered by this specification.

1.4This 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.