ASTM F1582-1998(2011) Standard Terminology Relating to Spinal Implants《脊椎骨植入物标准术语》.pdf

1、Designation: F1582 98 (Reapproved 2011)Standard Terminology Relating toSpinal Implants1This standard is issued under the fixed designation F1582; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number i

2、n parentheses indicates the year of last reapproval. Asuperscript epsilon () 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 ASTM

3、Standards:2E6 Terminology Relating to Methods of Mechanical TestingE1150 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, spinou

4、s 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.bolt, n

5、an 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 forms a

6、 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 create

7、d 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 eleme

8、nts 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 other

9、 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 boundtogeth

10、er 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, ribs

11、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 adjacent ver

12、tebralbodies 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 adjacent

13、 vertebral bodies.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved Dec. 1, 2011. Published January 2012. Originallyapproved in 1998. Last pre

14、vious edition approved in 2003 as F1582 98 (2003).DOI: 10.1520/F1582-98R11.2For 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

15、 ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.replacement disc, na structure intended to restore supportand motion between

16、 adjacent vertebral bodies.vertebral body replacement device, na structure which isdesigned to restore anatomic 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

17、 components or betweencomponents and bony elements of the spine, pelvis, or ribs.bolt interconnection, nan 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

18、 through a squeezingaction.DISCUSSIONFor example, crimps, wedges, set screws.screw interconnection, nan interconnection having animplant component sandwiched between the screw head (orscrew thread) and bony element or other implant compo-nents.sleeve interconnection, nan interconnection in which ani

19、mplant component passes through any opening that limitsmotion in one or more planes.interface, none of the 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 wh

20、ose long axis isparallel, or nearly so, to the long axis of the spine.cable, na multi-strand, flexible longitudinal element de-signed primarily to resist axial tension loading.hybrid longitudinal element, na longitudinal elementconsisting of two or more types of longitudinal elements ofdifferent siz

21、e or cross-section manufactured into a singleelement.plate, na longitudinal element asymmetrical in the trans-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,

22、 andtorsion.motion segment, ntwo adjacent vertebrae, the interveningdisc, and the associated ligamentous structures.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

23、including the spine,pelvis, ribs, or substitute structure.transverse element, na component or subassembly thatlinks longitudinal members together.vertebral span, nthe number of vertebra that are spanned bythe longitudinal element, including the vertebrae containinganchor components.Definitions Relat

24、ed to Spinal Implant Testing Defined inOther Documents, or are Established TerminologyDISCUSSIONIn certain 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

25、moment or load can be substituted when comparing devicesassigned to perform the same mechanical function. The 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

26、employed.fatigue, nthe process of progressive localized permanentstructural change occurring in a material 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.DISC

27、USSIONSee Definitions E1150.fatigue life, nthe number of loading cycles, N, of a specifiedcharacter that a given specimen sustains before failure of aspecified nature occurs.DISCUSSIONSee Definitions E1150fatigue strength at N Cycles, SnFL2, na value of stressfor failure at exactly N cycles as deter

28、mined from an S-Ndiagram. The value Snthus determined is subject to the sameconditions as those that apply 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 c

29、ould survive Nstress cycles in which Sm(mean stress) = 0. This is also known as themedian fatigue strength for N cycles (see Definitions E1150).fatigue test, na test designed to evaluate the cyclic loadproperties of a material, component, interconnection, sub-construct, construct, subassembly, or as

30、sembly.load ratio, R, A, nin fatigue loading, the algebraic ratio ofthe two loading parameters of a cycle.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)orF1582 98 (2011)2A 5Ma

31、ximum Load 2 Minimum Load!Maxium Load 1 Minimum Load!5Pmax2 Pmin!Pmax1 Pmin!(6)S-N diagram, na plot of stress against the 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 f

32、or a specified valueof Sm(mean stress) A,orR (load or stress ratio), and aspecified probability of survival. For N, a log scale is almostalways used. For S, a linear scale is used most often, but alog scale is sometimes used.DISCUSSIONSee Definitions E1150.static test, nsingle cycle loading tests de

33、signed to evaluatethe mechanical properties of materials, components, inter-connections, subconstructs, constructs, subassemblies, orassemblies.DISCUSSIONThe mechanical properties can include stiffness, flex-ibility, failure loads and stresses, and yield and ultimate strengthsdefined in the associat

34、ed test standard, that is, the properties associatedwith elastic and inelastic reactions when force is 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.D

35、ISCUSSIONStress is expressed in units of force per unit area(pounds-force per square inch, megapascals, and so forth). (SeeTerminology E6.)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 thr

36、ee orthogonal axes that aredefined in terms of the standard anatomic planes that they areperpendicular 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), do

37、rsal (posterior), cranial (cephalad or supe-rior), caudal (inferior), lateral, or medial. All rotations 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

38、broken down into their accordant anatomic compo-nents.4.2 It is recommended that the origin of the axes 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(Nonmandat

39、ory Information)X1. RATIONALEX1.1 Where available, the standard terms used in Defini-tions E1150 or Terminology E6 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 a

40、rerecommended. The selection of this coordinate system wasmade to avoid the differences in the myriad coordinate systemsused in the current published literature and by various institu-tions, for example, International Organization for Standardiza-tion (ISO), Department of Transportation,Armed Servic

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44、 ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1582 98 (2011)3