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ASTM F 2077 Document Information:
Title
Test Methods For Intervertebral Body Fusion Devices
ASTM International
Publication Date:
Apr 10, 2003
Scope:
This test method covers the materials and methods for the static and
dynamic testing of
intervertebral body fusion device assemblies, spinal implants designed
to promote arthrodesis at a
given spinal motion segment.
This test method is intended to provide a basis for the mechanical
comparison among past, present,
and future non-biologic intervertebral body fusion device assemblies.
This test method allows
comparison of intervertebral body fusion device assemblies with
different intended spinal locations
and methods of application to the intradiscal spaces. This test method
is intended to enable the
user to compare intervertebral body fusion device assemblies
mechanically and does not purport to
provide performance standards for intervertebral body fusion device
assemblies.
The test method describes static and dynamic tests by specifying load
types and specific methods of
applying these loads. These tests are designed to allow for the
comparative evaluation of
intervertebral body fusion device assemblies.
This test method does not address expulsion testing of intervertebral
body fusion device assemblies
(see X1.11).
Guidelines are established for measuring displacements, determining
the yield load or moment,
evaluating the stiffness, and strength of the intervertebral body
fusion device assemblies.
Some intervertebral body fusion device assemblies may not be testable
in all test configurations.
The values stated in SI units are to be regarded as the standard with
the exception of angular
measurements, which may be reported in terms of either degrees or
radians.
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.
Keywords:
- dynamic test methods
- intervertebral body fusion device
- spinal implants
- static test methods
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