ASTM F2694-2007 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses《活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程》.pdf
《ASTM F2694-2007 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses《活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2694-2007 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses《活动腰椎全椎间盘假体的功能及磨损评定的标准实施规程》.pdf(9页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F 2694 07Standard Practice forFunctional and Wear Evaluation of Motion-PreservingLumbar Total Facet Prostheses1This standard is issued under the fixed designation F 2694; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,
2、 the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides guidance for the functional,kinematic and wear testing of motion-preserving total
3、 facetprostheses for the lumbar spine. These implants are intended toallow 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 boneimplant interface or the static characteristics of the prosthesiscompon
4、ents. Fatigue characteristics are included, but only as aby-product of cyclic wear testing under facet load and thus arenot addressed in the typical process of generating an S-Ncharacterization.1.3 Biocompatibility of the materials used in a total facetprosthesis are not addressed in this practice.1
5、.4 The values stated in SI units are to be regarded as thestandard with the exception of angular measurements, whichmay be reported in either degrees or radians.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the us
6、er of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F 561 Practice for Retrieval and Analysis of Medical De-vices, and Associated Tissues and FluidsF 732 Test Meth
7、od for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF 1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip-Designs in Simulator DevicesF 1877 Practice for Characterization of ParticlesF 2346 Test Methods for Static and Dynamic Characteriza-tion of Spinal Artificial Discs
8、3. Terminology3.1 DefinitionsAll functional and kinematic testing termi-nology is consistent with the referenced standards, unlessotherwise stated.3.1.1 coordinate systems/axes, nglobal XYZ orthogonalaxes are defined following a right-handed Cartesian coordinatesystem in which the XY plane is parall
9、el to and co-planar withthe superior endplate of the inferior vertebral body. The globalaxes are fixed relative to the inferior vertebral body, which inthis practice is also considered to be stationary with respect tothe test machines frame. Lower case letters, xyz, denote a localmoving orthogonal c
10、oordinate system attached to the superiorvertebral body with directions initially coincident with those ofthe global XYZ axes, respectively. The 3D motion of thesuperior relative to inferior vertebra is specified and is to bemeasured in terms of sequential Eulerian angular rotationsabout the xyz axe
11、s, respectively (z axial rotation, x lateral bend,and y flexion-extension).3.1.1.1 origin, ncenter of the global coordinate systemthat is located at the posterior medial position on the superiorendplate of the inferior vertebral body.3.1.1.2 X-axis, npositive X-axis is to be directed anteri-orly rel
12、ative to the specimens initial unloaded position.3.1.1.3 Y-axis, npositive Y-axis is directed laterally (to-ward the left) relative to the specimens initial unloadedposition.3.1.1.4 Z-axis, npositive Z-axis is to be directed superi-orly relative to the specimens initial unloaded position.3.1.2 fluid
13、 absorption, nfluid absorbed by the devicematerial during testing or while implanted in vivo.3.1.3 functional failure, npermanent deformation or wearthat renders the total facet prosthesis assembly ineffective orunable to perform its intended function.3.1.4 interval net volumetric wear rate VRidurin
14、g cycleinterval i (mm3/million cycles), nVRi= WRi/r; where r =mass density (for example, units of g/mm3) of the wearmaterial.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Dev
15、ices.Current edition approved Dec. 1, 2007. Published December 2007.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM w
16、ebsite.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.5 interval net wear rate WRiduring cycle interval i(g/million cycles), nWRi=(NWi NWi-1)/(number of cyclesin interval i)106; for i =1,NWi-1=0.3.1.6 total facet prosthesis, nno
17、nbiologic structure in-tended to restore the support and motion of the naturalvertebral facet joint.3.1.7 kinematics profile, nrelative motion between adja-cent vertebral bodies that the total facet prosthesis is subjectedto while being tested.3.1.8 load profile, nloading that the device experiences
18、while being tested under a defined kinematics profile or theloading that the total facet prosthesis is subject to if tested inload control.3.1.9 radius of rotation, nthe distance between the centerof rotation and the functional position (for example, load-bearing contact point) of the total facet pr
19、osthesis, for a givenmotion (that is, flexion/extension, lateral bending, or axialrotation).3.1.10 mechanical failure, nfailure associated with adefect in the material (for example, fatigue crack) or of thebonding between materials that may or may not producefunctional failure.3.1.11 weight Siof soa
20、k control specimen (g), nS0initialand Siat end of cycle interval i.3.1.12 weight Wiof wear specimen (g), nW0initial and Wiat end of cycle interval i.3.1.13 net wear NWiof wear specimen (g), nNWi=(W0Wi)+(Si S0); loss in weight of the wear specimen correctedfor fluid absorption at end of cycle interva
21、l i.3.1.14 net volumetric wear NViof wear specimen (mm3),nNVi= NWi/r at end of cycle interval i; where r = massdensity (for example, units of g/mm3) of the wear material.3.1.15 run-out (cycles), nmaximum number of cycles thata test needs to be carried to if functional failure has not yetoccurred.3.1
22、.16 wear, nprogressive loss of material from the de-vice(s) or device components as a result of relative motion atthe surface with another body as measured by the change inmass of the total facet prosthesis or components of the totalfacet prosthesis. In the case of a non-articulating, complianttotal
23、 facet prosthesis, wear is defined simply as the loss ofmaterial from the prosthesis. Note that inferior and superiorbone interface components are excluded from this definition(see 5.2.2).3.1.17 facet load, nAP directed force (applied in thedirection of the global X-axis) representing the resultant
24、in themid-sagittal XZ plane applied by the superior vertebra thatsimulates the in vivo AP shear load Fxtransmitted fromsuperior to inferior vertebra and resisted by the total facetprosthesis.4. Summary of Practice4.1 This practice can be used to describe the function,kinematics, and wear behavior of
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