Historical
ASTM F2423-11(2016)
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses.
1.2 Both lumbar and cervical prostheses are addressed.
1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide.
1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed.
1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide.
1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces.
Content Provider
ASTM International [astm]
