significance And Use:

scope:

1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.

1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants, as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.

1.3 This standard defines test methods to measure the strength of spinal implant component interconnections and how to report test results.

1.4 The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.

1.5 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.

1.6 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.