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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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Article Information

vol. 3 no. 4 178-183
DOI 
https://doi.org/10.1016/j.esas.2009.11.001

Published By 
International Journal of Spine Surgery
Online ISSN 
2211-4599
History 
  • Published online January 1, 2009.

Copyright & Usage 
© 2009 SAS - The International Society for the Advancement of Spine Surgery. Published by Elsevier Inc. All rights reserved. This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Author Information

  1. Jove Graham, PhDa and
  2. Bradley T. Estes, PhDb,*
  1. aCenter for Health Research, Geisinger Health System, Danville, PA
  2. bDepartment of Surgery, Division of Orthopaedic Surgery, Duke University Medical Center, Durham, NC
  1. ↵* Corresponding author: Bradley Estes, PhD, Orthopaedic Research Laboratories, Department of Surgery, Division of Orthopaedic Surgery, 375 MSRB, Box 3093, Duke University Medical Center, Durham, North Carolina 27710. Phone: (919) 684-6882; Fax: (919) 681-8490. E-mail address: bradley.estes{at}duke.edu
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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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  • Article
    • 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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Keywords

  • Standards
  • Test methods
  • spinal devices
  • Spinal arthroplasty
  • ASTM
  • ISO

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