ASTM F1582-1998(2003) Standard Terminology Relating to Spinal Implants《脊椎骨植入物标准术语》.pdf

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1、Designation: F 1582 98 (Reapproved 2003)Standard Terminology Relating toSpinal Implants1This standard is issued under the fixed designation F 1582; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 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 terminology covers basic terms and considerationsfor spinal implant devices and their mechanical analyses.2. Referenced Documents2.1 AS

3、TM Standards:2E 6 Terminology Relating to Methods of Mechanical Test-ingE 1150 Definitions of Terms Relating to Fatigue33. TerminologyDefinitions Related to Spinal Implant Devicesanchor, ncomponents that are directly attached to the bonyelements of the spine (sacrum, lamina, pedicle, vertebralbody,

4、spinous process, transverse process, the pelvis, orribs).band, na flexible anchor component with a noncircularcross section that connects the bony elements of the spine,pelvis, or ribs to each other or to other implant componentsusing a knot or similar tying mechanism, forming a locked,closed loop.b

5、olt, nan anchor component that connects to the bonyelements of the spine, pelvis, or ribs by means of threadswith the lead threads accomodating a nut thus sandwichingthe bony element or implant component between the nut orwasher and bolt head or other fixed stop.expansion anchor, na component that f

6、orms a connectionto bony element by means of a mechanism which enlargesonce the component is inserted into the bony elements.hook, nan anchoring component that fastens to the spine bymeans of a curved blade passed under or over lamina,transverse or spinous processes or into an anatomic orsurgically

7、created notch or opening.hook blade, nthat portion of a spinal hook that is placedunder, over, or into a bony structure to provide attachment.hook bodythat portion of a spinal hook that connects thehook blade to the longitudinal element.post, na non-threaded anchor component that connects tothe bony

8、 elements of the spine, pelvis, or ribs by means of anon-threaded hole in the bony element.screw, nan anchor component that connects to the bonyelements of the spine, pelvis, or ribs by means of threads.staple, nan anchor component that connects the bonyelements of the spine, pelvis, or ribs to each

9、 other or to otherimplant components by using at least two interconnectedposts.wirea single strand flexible anchor component with acircular cross section that connects the bony elements of thespine, pelvis, or ribs to each other or to other implantcomponents. A series of wire components can be bound

10、together to form a cable (see cable).assembly, na complete implant configuration (not includingspine, pelvis, ribs, or substitute material) as intended forsurgical ponent, nany single element used in an assembly.construct, na complete implant configuration attached toand including the spine, pelvis,

11、 ribs or substitute material asintended for surgical use.interbody spacer, na structure (biologic or synthetic) toreplace (partially or totally) the vertebral body or interver-tebral disk(s), or both.intervertebral body fusion devices, na structure which isplaced in the disc space between two adjace

12、nt vertebralbodies to provide support for eventual arthrodeses of the twoadjacent vertebral bodies.intervertebral body fusion cage, na hollow device whichcontains graft material.partial replacement disca structure intended to restore aportion of the support and motion or a portion thereof,between ad

13、jacent vertebral bodies.replacement disc, na structure intended to restore supportand motion between adjacent vertebral bodies.1This terminology is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spin

14、al Devices.Current edition approved Nov. 1, 2003. Published November 2003. Originallyapproved in 1998. Last previous edition approved in 1998 as F 1582 98.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM

15、Standards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.vertebral body replacement device, na structure which isdesigned to restore anat

16、omic position and support to asection of spine lacking one or more vertebral bodies andintervening disc(s).interconnection, nthe mechanical interface or connectionmechanism between at least two components or betweencomponents and bony elements of the spine, pelvis, or ribs.bolt interconnection, nan

17、interconnection having an im-plant component sandwiched between two nuts or between anut and fixed stop.clamp, nan interconnection component whose mechanismto secure the longitudinal element is through a squeezingaction.DISCUSSIONFor example, crimps, wedges, set screws.screw interconnection, nan int

18、erconnection having animplant component sandwiched between the screw head (orscrew thread) and bony element or other implant compo-nents.sleeve interconnection, nan interconnection in which animplant component passes through any opening that limitsmotion in one or more planes.interface, none of the

19、two mating surfaces, lines or points ofcontact within an interconnection between two components,between any component and bone, or between two bonyelements.longitudinal element, na component whose long axis isparallel, or nearly so, to the long axis of the spine.cable, na multi-strand, flexible long

20、itudinal element de-signed primarily to resist axial tension loading.hybrid longitudinal element, na longitudinal elementconsisting of two or more types of longitudinal elements ofdifferent size or cross-section manufactured into a singleelement.plate, na longitudinal element asymmetrical in the tra

21、ns-verse plane and designed to resist tension, compression,bending, and torsion.rod, na longitudinal element symmetrical in the transverseplane designed to resist tension, compression, bending, andtorsion.motion segment, ntwo adjacent vertebrae, the interveningdisc, and the associated ligamentous st

22、ructures.subassembly, nany portion of an implant assembly that iscomposed of two or more components.subconstruct, nany portion of an implant construct that iscomposed of two or more components including the spine,pelvis, ribs, or substitute structure.transverse element, na component or subassembly t

23、hatlinks longitudinal members together.vertebral span, nthe number of vertebra that are spanned bythe longitudinal element, including the vertebrae containinganchor components.Definitions Related to Spinal Implant Testing Defined inOther Documents, or are Established TerminologyDISCUSSIONIn certain

24、instances, a value for moment or load can besubstituted for stress when describing fatigue life. This is true in casesin which the actual stress values are unknown or not easily obtainable.The moment or load can be substituted when comparing devicesassigned to perform the same mechanical function. T

25、he value for loador moment thus determined is subject to the same conditions as thosethat apply to stress in this terminology standard. However, wheneverpossible, stress should be the standard employed.fatigue, nthe process of progressive localized permanentstructural change occurring in a material

26、subjected to con-ditions that produce fluctuating stresses and strains at somepoint or points and that may culminate in cracks or completefracture after a sufficient number of fluctuations.DISCUSSIONSee Definitions E 1150.fatigue life, nthe number of loading cycles, N, of a specifiedcharacter that a

27、 given specimen sustains before failure of aspecified nature occurs.DISCUSSIONSee Definitions E 1150fatigue strength at N Cycles, SnFL2, na value of stressfor failure at exactly N cycles as determined from an S-Ndiagram. The value Snthus determined is subject to the sameconditions as those that appl

28、y to the S-N diagram.DISCUSSIONThe value of Snwhich is commonly found in theliterature is the value of Smax(maximum stress)orSa(stress amplitude)at which 50 % of the specimens of a given sample could survive Nstress cycles in which Sm(mean stress) = 0. This is also known as themedian fatigue strengt

29、h for N cycles (see Definitions E 1150).fatigue test, na test designed to evaluate the cyclic loadproperties of a material, component, interconnection, sub-construct, construct, subassembly, or assembly.load ratio, R, A, nin fatigue loading, the algebraic ratio ofthe two loading parameters of a cycl

30、e.DISCUSSIONThe most widely used ratios are:R 5Minimum LoadMaximum Load5PminPmax(1)orSminSmax(2)orR 5Valley LoadPeak Load(3)andA 5Loading AmplitudeMean Load5PaPm(4)orSaSm(5)orA 5Maximum Load 2 Minimum Load!Maxium Load 1 Minimum Load!5Pmax2 Pmin!Pmax1 Pmin!(6)S-N diagram, na plot of stress against th

31、e number of cyclesto failure. The stress can be maximum stress Smax, minimumstress Smin, stress range S or Sr, or alternating stress Sa. Thediagram indicates the S-N relationship for a specified valueof Sm(mean stress) A,orR (load or stress ratio), and aspecified probability of survival. For N, a lo

32、g scale is almostF 1582 98 (2003)2always used. For S, a linear scale is used most often, but alog scale is sometimes used.DISCUSSIONSee Definitions E 1150.static test, nsingle cycle loading tests designed to evaluatethe mechanical properties of materials, components, inter-connections, subconstructs

33、, constructs, subassemblies, orassemblies.DISCUSSIONThe mechanical properties can include stiffness, flex-ibility, failure loads and stresses, and yield and ultimate strengthsdefined in the associated test standard, that is, the properties associatedwith elastic and inelastic reactions when force is

34、 applied or those thatinvolve a relationship between stress and strain.stress, S, nthe intensity at a point in a body of the forces orcomponents of force that act on a given plane through thepoint.DISCUSSIONStress is expressed in units of force per unit area(pounds-force per square inch, megapascals

35、, and so forth). (SeeTerminology E 6.)4. Coordinate System Related to the Application ofSpinal Implant Devices4.1 The coordinate system used in the testing of spinalimplant devices is a system of three orthogonal axes that aredefined in terms of the standard anatomic planes that they areperpendicula

36、r to, for example, transverse (horizontal or axial),coronal (frontal), and sagittal (median). Translations are alsodefined in terms of standard clinical directions, for example,ventral (anterior), dorsal (posterior), cranial (cephalad or supe-rior), caudal (inferior), lateral, or medial. All rotatio

37、ns followthe right hand rule and are defined using current clinicalterminology, for example, right or left side bending, flexion,extension, or twist. In addition, translations and rotationsshould be broken down into their accordant anatomic compo-nents.4.2 It is recommended that the origin of the ax

38、es be locatedin a rigid structure such as bone. In addition, the orientation ofthe coordinate system, the designation of the three axes andlocation of the origin should be reported.APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 Where available, the standard terms used in Defini-tions E 1150 or

39、Terminology E 6 were used.X1.2 The coordinate system proposed is based on standardengineering practices for defining an orthogonal coordinatesystem. For clinical relevancy, anatomic or clinical terms arerecommended. The selection of this coordinate system wasmade to avoid the differences in the myri

40、ad coordinate systemsused in the current published literature and by various institu-tions, for example, International Organization for Standardiza-tion (ISO), Department of Transportation, Armed Services, andso on.ASTM International takes no position respecting the validity of any patent rights ass

41、erted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time b

42、y the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will rece

43、ive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM Inte

44、rnational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1582 98 (2003)3