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ASTM F2694-07(2013)

(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
5.1 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.  
5.2 Spinal Testing Apparatus:
5.2.1 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.  
5.2.2 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.  
5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.  
5.2.4 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. Note 1—This setup would require two rotational actuators and one translational actuator.
FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet LoadingNote 1—This setup would requ...
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 standard. No other units of measurement are included in this standard.  
1.4.1 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
28-Feb-2013
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(2013) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet ProsthesesASTM F2694-07(2013) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
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ASTM F2694-07(2013) - 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 (Reapproved 2013)
Standard Practice 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 Used in Total Joint Prostheses
F1714 GuideforGravimetricWearAssessmentofProsthetic
1.1 This practice provides guidance for the functional,
Hip Designs in Simulator Devices
kinematic and wear testing of motion-preserving total facet
F1877 Practice for Characterization of Particles
prostheses for the lumbar spine.These implants are intended to
F2346 Test Methods for Static and Dynamic Characteriza-
allow motion and lend support to the functional spinal unit(s)
tion of Spinal Artificial Discs
through replacement of the natural facets.
1.2 This test method is not intended to address the bone 3. Terminology
implant interface or the static characteristics of the prosthesis
3.1 All functional and kinematic testing terminology is
components. Fatigue characteristics are included, but only as a
consistent with the referenced standards, unless otherwise
by-product of cyclic wear testing under facet load and thus are
stated.
not addressed in the typical process of generating an S-N
3.2 Definitions:
characterization.
3.2.1 coordinate systems/axes, n—global XYZ orthogonal
1.3 Biocompatibility of the materials used in a total facet
axes are defined following a right-handed Cartesian coordinate
prosthesis are not addressed in this practice.
system in which the XY plane is parallel to and co-planar with
the superior endplate of the inferior vertebral body. The global
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this axes are fixed relative to the inferior vertebral body, which in
this practice is also considered to be stationary with respect to
standard.
1.4.1 The values stated in SI units are to be regarded as the thetestmachine’sframe.Lowercaseletters, xyz,denotealocal
moving orthogonal coordinate system attached to the superior
standard with the exception of angular measurements, which
may be reported in either degrees or radians. vertebral body with directions initially coincident with those of
the global XYZ axes, respectively. The 3D motion of the
1.5 This standard does not purport to address all of the
superior relative to inferior vertebra is specified and is to be
safety concerns, if any, associated with its use. It is the
measured in terms of sequential Eulerian angular rotations
responsibility of the user of this standard to establish appro-
about the xyz axes, respectively (z axial rotation, x lateral bend,
priate safety and health practices and determine the applica-
and y flexion-extension).
bility of regulatory limitations prior to use.
3.2.1.1 origin, n—center of the global coordinate system
2. Referenced Documents
that is located at the posterior medial position on the superior
2
endplate of the inferior vertebral body.
2.1 ASTM Standards:
F561 Practice for Retrieval and Analysis of Medical 3.2.1.2 X-axis, n—positive X-axisistobedirectedanteriorly
Devices, and Associated Tissues and Fluids relative to the specimen’s initial unloaded position.
F732 Test Method for Wear Testing of Polymeric Materials
3.2.1.3 Y-axis, n—positive Y-axis is directed laterally (to-
ward the left) relative to the specimen’s initial unloaded
position.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3.2.1.4 Z-axis, n—positive Z-axis is to be directed superi-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 on Spinal Devices. orly relative to the specimen’s initial unloaded position.
Current edition approved March 1, 2013. Published March 2013. Originally
3.2.2 fluid absorption, n—fluid absorbed by the device
approved in 2007. Last previous edition approved in 2007 as F2694—07. DOI:
material during testing or while implanted in vivo.
10.1520/F2694-07R13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3.2.3 functional failure, n—permanent deformation or wear
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
that renders the total facet prosthesis assembly ineffective or
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. unable to perform its intended function.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2694 − 07 (2013)
3.2.4 i
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
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
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off