1、Designation: F1582 98 (Reapproved 2016)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 Fatigue (Withdrawn1996)33. TerminologyDefinitions Related to Spinal Implant Devicesanchor, ncomponents that are directly attached to the bonyelements of the spine (sacrum, lamina, pedicle, verte
4、bralbody, spinous process, transverse process, the pelvis, orribs).assembly, na complete implant configuration (not includingspine, pelvis, ribs, or substitute material) as intended forsurgical use.band, na flexible anchor component with a noncircular crosssection that connects the bony elements of
5、the spine, pelvis,or ribs to each other or to other implant components using aknot or similar tying mechanism, forming a locked, closedloop.bolt, nan anchor component that connects to the bonyelements of the spine, pelvis, or ribs by means of threadswith the lead threads accommodating a nut, thus sa
6、ndwich-ing the bony element or implant component between the nutor washer and bolt head or other fixed stop.bolt interconnection, nan interconnection having an implantcomponent sandwiched between two nuts or between a nutand fixed stop.cable, na multi-strand, flexible longitudinal element de-signed
7、primarily to resist axial tension loading.clamp, nan interconnection component whose mechanism tosecure the longitudinal element is through a squeezingaction.DISCUSSIONFor example, crimps, wedges, set ponent, nany single element used in an assembly.construct, na complete implant configuration attach
8、ed toand including the spine, pelvis, ribs or substitute material asintended for surgical use.expansion anchor, na component that forms a connection tobony element by means of a mechanism which enlarges oncethe component is inserted into the bony elements.hook, nan anchoring component that fastens t
9、o the spine bymeans of a curved blade passed under or over lamina,transverse or spinous processes or into an anatomic orsurgically 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
10、spinal hook that connects thehook blade to the longitudinal element.hybrid longitudinal element, na longitudinal element con-sisting of two or more types of longitudinal elements ofdifferent size or cross-section manufactured into a singleelement.interbody spacer, na structure (biologic or synthetic
11、) toreplace (partially or totally) the vertebral body or interver-tebral disk(s), or both.interconnection, nthe mechanical interface or connectionmechanism between at least two components or betweencomponents and bony elements of the spine, pelvis, or ribs.interface, none of the two mating surfaces,
12、 lines or points ofcontact within an interconnection between two components,between any component and bone, or between two bonyelements.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25
13、 on Spinal Devices.Current edition approved Oct. 1, 2016. Published October 2016. Originallyapproved in 1998. Last previous edition approved in 2011 as F1582 98 (2011).DOI: 10.1520/F1582-98R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at se
14、rviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken,
15、 PA 19428-2959. United States1intervertebral body fusion cage, na hollow device whichcontains graft material.intervertebral body fusion devices, na structure which isplaced in the disc space between two adjacent vertebralbodies to provide support for eventual arthrodeses of the twoadjacent vertebral
16、 bodies.longitudinal element, na component whose long axis isparallel, or nearly so, to the long axis of the spine.motion segment, ntwo adjacent vertebrae, the interveningdisc, and the associated ligamentous structures.partial replacement disca structure intended to restore aportion of the support a
17、nd motion or a portion thereof,between adjacent vertebral bodies.plate, na longitudinal element asymmetrical in the transverseplane and designed to resist tension, compression, bending,and torsion.post, na non-threaded anchor component that connects to thebony elements of the spine, pelvis, or ribs
18、by means of anon-threaded hole in the bony element.replacement disc, na structure intended to restore supportand motion between adjacent vertebral bodies.rod, na longitudinal element symmetrical in the transverseplane designed to resist tension, compression, bending, andtorsion.screw, nan anchor com
19、ponent that connects to the bonyelements of the spine, pelvis, or ribs by means of threads.screw interconnection, nan interconnection having an im-plant component sandwiched between the screw head (orscrew thread) and bony element or other implant compo-nents.sleeve interconnection, nan interconnect
20、ion in which animplant component passes through any opening that limitsmotion in one or more planes.staple, nan anchor component that connects the bony ele-ments of the spine, pelvis, or ribs to each other or to otherimplant components by using at least two interconnectedposts.subassembly, nany port
21、ion 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 thatlinks longitudinal members t
22、ogether.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).vertebral span, nthe number of vertebra that are spanned bythe longitudinal element, including the verteb
23、rae containinganchor components.wire, na 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 boundtogether to form a cable (see cable).Definit
24、ions Related to Spinal Implant Testing Defined inOther Documents, or 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 obtainabl
25、e.The 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 sta
26、ndard 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 fluctuation
27、s.DISCUSSIONSee 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
28、 determined 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 sa
29、mple could 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,subconstruct, construct, subassembly, o
30、r assembly.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)andF1582 98 (2016)2A 5Loading AmplitudeMean Load5PaPm(4)orSaSm(5)orA
31、 5Maximum Load 2 Minimum Load!Maxium Load1Minimum Load!5Pmax2 Pmin!Pmax1Pmin!(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
32、for 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,interconnections, subconstructs, constructs, subassemblies,or assemblies.DISCUSSIONThe mechanical properties can include stiffness,flexibility, failure loads and stresses, and yield and ultimate strengthsdefined in the associated t
34、est 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.DISCU
35、SSIONStress 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 three o
36、rthogonal 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), dorsal
37、 (posterior), cranial (cephalad orsuperior), caudal (inferior), lateral, or medial. All rotationsfollow the 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
38、 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(Nonmandatory In
39、formation)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 arereco
40、mmended. The selection of this coordinate system wasmade to avoid the differences in the myriad coordinate systemsused in the current published literature and by variousinstitutions, for example, International Organization for Stan-dardization (ISO), Department of Transportation, ArmedServices, and
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