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ASTM F2694-07

(Practice)

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

SIGNIFICANCE AND USE
Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may be a unilateral or bilateral design.
Spinal Testing Apparatus:
Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.
Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.
The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.
The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads.
Load and Motion:
Facet loads (fx) are initially applied in the direction of the positive X-axis.
Flexion load and motion are positive moment and rotation about the Y-axis.
Extension load and motion are negative moment and rotation about the Y-axis.
Lateral bend load and motion are positive and negativ...
SCOPE
1.1 This practice provides guidance for the functional, kinematic and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.
1.2 This test method is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating an S-N characterization.
1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.
1.4 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians.
1.5 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.

General Information

Status
Historical
Publication Date
30-Nov-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.25 - Spinal Devices
Current Stage
Ref Project

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ASTM F2694-07 - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet ProsthesesASTM F2694-07 - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
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ASTM F2694-07 - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2694 − 07
StandardPractice for
Functional and Wear Evaluation of Motion-Preserving
1
Lumbar Total Facet Prostheses
This standard is issued under the fixed designation F2694; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2346 Test Methods for Static and Dynamic Characteriza-
tion of Spinal Artificial Discs
1.1 This practice provides guidance for the functional,
kinematic and wear testing of motion-preserving total facet
3. Terminology
prostheses for the lumbar spine.These implants are intended to
3.1 All functional and kinematic testing terminology is
allow motion and lend support to the functional spinal unit(s)
consistent with the referenced standards, unless otherwise
through replacement of the natural facets.
stated.
1.2 This test method is not intended to address the bone
3.2 Definitions:
implant interface or the static characteristics of the prosthesis
3.2.1 coordinate systems/axes, n—global XYZ orthogonal
components. Fatigue characteristics are included, but only as a
axes are defined following a right-handed Cartesian coordinate
by-product of cyclic wear testing under facet load and thus are
system in which the XY plane is parallel to and co-planar with
not addressed in the typical process of generating an S-N
the superior endplate of the inferior vertebral body. The global
characterization.
axes are fixed relative to the inferior vertebral body, which in
1.3 Biocompatibility of the materials used in a total facet
this practice is also considered to be stationary with respect to
prosthesis are not addressed in this practice.
thetestmachine’sframe.Lowercaseletters, xyz,denotealocal
moving orthogonal coordinate system attached to the superior
1.4 The values stated in SI units are to be regarded as the
vertebral body with directions initially coincident with those of
standard with the exception of angular measurements, which
the global XYZ axes, respectively. The 3D motion of the
may be reported in either degrees or radians.
superior relative to inferior vertebra is specified and is to be
1.5 This standard does not purport to address all of the
measured in terms of sequential Eulerian angular rotations
safety concerns, if any, associated with its use. It is the
about the xyz axes, respectively (z axial rotation, x lateral bend,
responsibility of the user of this standard to establish appro-
and y flexion-extension).
priate safety and health practices and determine the applica-
3.2.1.1 origin, n—center of the global coordinate system
bility of regulatory limitations prior to use.
that is located at the posterior medial position on the superior
2. Referenced Documents endplate of the inferior vertebral body.
2
3.2.1.2 X-axis, n—positive X-axisistobedirectedanteriorly
2.1 ASTM Standards:
relative to the specimen’s initial unloaded position.
F561 Practice for Retrieval and Analysis of Medical
Devices, and Associated Tissues and Fluids
3.2.1.3 Y-axis, n—positive Y-axis is directed laterally (to-
F732 Test Method for Wear Testing of Polymeric Materials
ward the left) relative to the specimen’s initial unloaded
Used in Total Joint Prostheses
position.
F1714 GuideforGravimetricWearAssessmentofProsthetic
3.2.1.4 Z-axis, n—positive Z-axis is to be directed superi-
Hip Designs in Simulator Devices
orly relative to the specimen’s initial unloaded position.
F1877 Practice for Characterization of Particles
3.2.2 fluid absorption, n—fluid absorbed by the device
material during testing or while implanted in vivo.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3.2.3 functional failure, n—permanent deformation or wear
Surgical Materials and Devices and is the direct responsibility of Subcommittee
that renders the total facet prosthesis assembly ineffective or
F04.25 on Spinal Devices.
unable to perform its intended function.
Current edition approved Dec. 1, 2007. Published December 2007. DOI:
10.1520/F2694-07.
3.2.4 interval net volumetric wear rate VR during cycle
i
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 3
interval i (mm /million cycles), n—VR = WR/ρ; where ρ =
i i
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
mass density (for example, units of g/mm ) of the wear
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. material.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2694 − 07
3.2.5 interval net wear rate WR during cycle interval i c
...

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1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
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    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off