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ASTM F1798-21
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
1.1This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.
1.2The 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.
1.3This standard defines test methods to measure the strength of spinal implant component interconnections and how to report test results.
1.4The 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.
1.5This 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.
1.6This 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.
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ASTM International [astm]
