ASTM F2423-2005 Standard Guide for Functional Kinematic and Wear Assessment of Total Disc Prostheses《总脊面假体的功能的、运动学的和磨损的评估标准指南》.pdf
《ASTM F2423-2005 Standard Guide for Functional Kinematic and Wear Assessment of Total Disc Prostheses《总脊面假体的功能的、运动学的和磨损的评估标准指南》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2423-2005 Standard Guide for Functional Kinematic and Wear Assessment of Total Disc Prostheses《总脊面假体的功能的、运动学的和磨损的评估标准指南》.pdf(10页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F 2423 05Standard Guide forFunctional, Kinematic, and Wear Assessment of Total DiscProstheses1This standard is issued under the fixed designation F 2423; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last
2、 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 guide is intended to provide guidance for thefunctional, kinematic, and wear testing of total disc prosthesesand, to
3、 this end, describes test methods for assessment of thewear or functional characteristics, or both, of total discprostheses.1.2 Both lumbar and cervical prostheses are addressed.1.3 Load and kinematic profiles for lumbar and cervicaldevices are not identical and, therefore, are addressed sepa-rately
4、 in the guide.1.4 Partial disc replacements, such as nucleus replacementsor facet joint replacements, are not intended to be addressed.1.5 Wear is assessed using a weight loss method in a testingmedium as defined in this guide.1.6 This guide is not intended to address any potentialfailure mode as it
5、 relates to the fixation of the implant to itsbony interfaces.1.7 It is the intent of this guide to enable comparison ofintervertebral disc (IVD) prostheses with regard to kinematic,functional, and wear characteristics when tested under thespecified conditions. It must be recognized, however, that t
6、hereare many possible variations in the in vivo conditions. A singlelaboratory simulation with a fixed set of parameters may not beuniversally representative.1.8 In order that the data be reproducible and comparablewithin and between laboratories, it is essential that uniformprocedures are establish
7、ed. This guide is intended to facilitateuniform methods for testing and reporting of data for total discreplacement prostheses.1.9 Without a substantial clinical retrieval history of IVDprostheses, actual loading profiles and patterns cannot bedelineated at the time of the writing of this guide. It
8、thereforefollows that the load and motion conditions specified by thisguide do not necessarily accurately reproduce those occurringin vivo. Rather, the maximum loads and motions specified inthis guide represent a severe and therefore conservative casefor testing the wear properties of IVD prostheses
9、. Because ofthis, a substantially greater rate of wear may be realized thanthat which may occur during the routine daily activities of atypical patient. It should be noted, however, that a fullcharacterization of a candidate IVD prosthesis should includetesting under both typical and extreme conditi
10、ons.1.10 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.1.11 This guide is not intended to be a performance stan-dard. It is the responsibility of the user of this guide tocharacterize the
11、safety and effectiveness of the prosthesis underevaluation.1.12 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-b
12、ility 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 1582 Terminology Relating to Spinal ImplantsF 1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip-Design
13、s in Simulator DevicesF 1877 Practice for Characterization of ParticlesF 2077 Test Methods For Intervertebral Body Fusion De-vices3. Terminology3.1 DefinitionsAll functional and kinematic testing termi-nology is consistent with the referenced standards, unlessotherwise stated.3.1.1 coordinate system
14、/axes, nglobal XYZ orthogonalaxes are defined following a right-handed Cartesian coordinatesystem in which the XY plane is to bisect the sagittal planeangle between superior and inferior surfaces that are intendedto simulate the adjacent vertebral end plates. The global axesare stationary relative t
15、o the IVD prostheses inferior end plate1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved Nov. 15, 2005. Published January 2006.2For referenced ASTM
16、 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 website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohoc
17、ken, PA 19428-2959, United States.fixture, which, in this guide, is also considered to be stationarywith respect to the test machines frame. Lower case letters,xyz, denote a local, moving orthogonal coordinate systemattached to the superior end plate fixturing with directionsinitially coincident wit
18、h those of the global XYZ axes, respec-tively. The 3-D motion of the superior relative to inferior endplate fixture is specified and is to be measured in terms ofsequential Eulerian angular rotations about the xyz axes,respectively (z, axial rotation; x, lateral bending; and y,flexion-extension).3.1
19、.1.1 origin, ncenter of the global coordinate system islocated at the initial position of the total disc replacementsinstantaneous center of rotation (COR). F 15823.1.1.2 X-axis, npositive X-axis is a global fixed axisrelative to the testing machines stationary base and is to bedirected anteriorly r
20、elative to the specimens initial unloadedposition.3.1.1.3 Y-axis, npositive Y-axis is a global fixed axisrelative to the testing machines stationary base and is directedlaterally relative to the specimens initial unloaded position.3.1.1.4 Z-axis, npositive Z-axis is a global fixed axisrelative to th
21、e testing machines stationary base and is to bedirected superiorly relative to the specimens initial unloadedposition.3.1.1.5 x-axis, npositive x-axis is a fixed axis relative tothe IVD prosthesis and a moving axis relative to the globalcoordinate system and is directed anteriorly relative to thepro
22、sthesis.3.1.1.6 y-axis, npositive y-axis is a fixed axis relative tothe IVD prosthesis and a moving axis relative to the globalcoordinate system and is directed laterally relative to theprosthesis.3.1.1.7 z-axis, npositive z-axis is a fixed axis relative tothe IVD prosthesis and a moving axis relati
23、ve to the globalcoordinate system and is directed superiorly relative to theprosthesis.3.1.2 degradation, nloss of material or function or mate-rial properties as a result of causes other than that associatedwith wear.3.1.3 fluid absorption, nfluid absorbed by the devicematerial during testing or wh
24、ile implanted in vivo.3.1.4 functional failure, npermanent deformation or wearthat renders the IVD prosthesis assembly ineffective or unableto resist load/motion or any secondary effects that result in areduction of clinically relevant motions or the motions in-tended by the design of the device.3.1
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