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Research ArticleFull Length Article
Open Access

What standards can (and can't) tell us about a spinal device

Jove Graham and Bradley T. Estes
International Journal of Spine Surgery January 2009, 3 (4) 178-183; DOI: https://doi.org/10.1016/j.esas.2009.11.001
Jove Graham
aCenter for Health Research, Geisinger Health System, Danville, PA
PhD
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Bradley T. Estes
bDepartment of Surgery, Division of Orthopaedic Surgery, Duke University Medical Center, Durham, NC
PhD
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  • For correspondence: bradley.estes@duke.edu
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    Fig. 1

    The evolution of flexion/extension test configurations (A) initial concept using a stainless steel ball about which to rotate to mimic the rotations of the lumbar spine, (B) intermediate concept employing external rocker arms to generate flexion/extension motion, and (C) final concept drawing of assembly used in extra-discal standard.

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    Table 1

    Examples of standard material specifications and test methods relevant to spinal implant devices

    Material specifications
    ASTM F67Unalloyed Titanium for Surgical Implant Applications
    ASTM F75Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
    ASTM F136Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
    ASTM F648Ultrahigh Molecular Weight Polyethylene (UHMWPE) Powder and Fabricated Form for Surgical Implants
    ASTM F2026Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
    Spinal fusion systems
    ASTM F1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
    ASTM F1798Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
    ASTM F2193Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
    ASTM F2706Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
    ISO 12189Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support
    Intervertebral body fusion devices (cages)
    ASTM F2077Test Methods for Intervertebral Body Devices
    ASTM F2267Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
    Total disc replacements
    ASTM F2346Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
    ASTM F2423Standard Guide for Functional, Kinematic and Wear Assessment of Total Disc Prostheses
    ISO 18192-1Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
    Other nonfusion devices or systems
    ASTM F2624Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
    ASTM F2694Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
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International Journal of Spine Surgery
Vol. 3, Issue 4
1 Jan 2009
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What standards can (and can't) tell us about a spinal device
Jove Graham, Bradley T. Estes
International Journal of Spine Surgery Jan 2009, 3 (4) 178-183; DOI: 10.1016/j.esas.2009.11.001

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What standards can (and can't) tell us about a spinal device
Jove Graham, Bradley T. Estes
International Journal of Spine Surgery Jan 2009, 3 (4) 178-183; DOI: 10.1016/j.esas.2009.11.001
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    • Abstract
    • Introduction
    • Different types of standards
    • How standards come to be (Who writes standards?)
    • Benefits of standards (Why do we use standards?)
    • Examples of current spine standards
    • The process of standards development
    • Limitations of standards (What can't they do?)
    • Clinical failure modes, challenges, and conclusions
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