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ASTM F 1717 Document Information:
Title
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM International
Publication Date:
Apr 1, 2004
Scope:
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.
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.
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.
These test methods establish guidelines for measuring displacements,
determining the yield load,
and evaluating the stiffness and strength of the spinal implant
assembly.
Some spinal constructs may not be testable in all test configurations.
Values stated in SI units are to be regarded as standard.
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:
- fatigue test methods
- spinal implant assembly
- spinal implant construct
- static test methods
- vertebrectomy model
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