1. Scope

1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine.

1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device.

1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.

1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.

1.5 Some spinal constructs may not be testable in all test configurations.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 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

D638 Test Method for Tensile Properties of Plastics

E4 Practices for Force Verification of Testing Machines

E6 Terminology Relating to Methods of Mechanical Testing

E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (-N) Fatigue Data

E1150 Definitions of Terms Relating to Fatigue

F1582 Terminology Relating to Spinal Implants

F2077 Test Methods For Intervertebral Body Fusion Devices

Keywords

fatigue test methods; spinal implant assembly; spinal implant construct; static test methods ; vertebrectomy model;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1717-11A

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