ASTM F1798-97(2003)
Historical Standard: ASTM F1798-97(2003) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
SUPERSEDED (see Active link, below)
ASTM F1798
1. Scope
1.1 This guide 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 guide 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 guide 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 guide sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.
1.4 The values stated in SI units are to be regarded as standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E4 Practices for Force Verification of Testing Machines
F1582 Terminology Relating to Spinal Implants
Keywords
gripping capacity; interconnection; run out; spinal arthrodesis implant; subassembly; Arthrodesis implants; Fatigue--surgical implant materials; Gripping capacity; Interconnection mechanisms; Spinal implants; Static tests--orthopaedic materials/applications; Subassemblies ;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1798-97R03
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