ASTM F1798-13 Standard Test Method for Evaluation of Static and Fatigue Properties of Interconnect Mechanisms and Sub-Assemblies Used in Spinal Arthrodesis Implants

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

The purpose of this test method is to provide a tool to mechanically characterize different designs of spinal implant interconnects. As a result, various components and interconnects must be combined for static and fatigue testing of the spinal implant structure.

The purpose of this test method is not to describe the performance levels of spinal implants as there is insufficient information to address the analysis of spinal implant structures or substructures or to predict the consequences of using certain spinal implant designs.

This test method provides definitions for the strength of the component interconnections of spinal implants, the possible test methods themselves, and the test results to be used in reporting.

Values ​​stated in SI units should be considered standard, except for angular measurements that can be reported in degrees or radians.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

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