1、Designation: F 2193 02 (Reapproved 2007)Standard Specifications and Test Methods forComponents Used in the Surgical Fixation of the SpinalSkeletal System1This standard is issued under the fixed designation F 2193; the number immediately following the designation indicates the year oforiginal adoptio
2、n or, in the case of revision, 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 These specifications and test methods are intended toprovide a comprehensi
3、ve reference for the components ofsystems used in the surgical fixation of the spinal skeletalsystem. The document catalogs standard specifications thatspecify material, labeling, and handling requirements. Thespecifications and test methods also establish common termi-nology that can be used to des
4、cribe the size and other physicalcharacteristics of spinal components and performance defini-tions related to the performance of spinal components. Addi-tionally, the specifications and test methods establish perfor-mance requirements and standard test methods to consistentlymeasure performance-rela
5、ted mechanical characteristics ofspinal components.1.2 These specifications and test methods are part of a seriesof standards addressing systems used in the surgical fixation ofthe spinal skeletal system. These specifications and test meth-ods concentrate on the individual components, which are foun
6、din many spinal fixation systems. If the user is interested inevaluating the next level in the spinal fixation system chain, theinterconnections between individual components and subas-semblies (two or more components), the user should consultGuide F 1798.At the highest level in this chain is Test M
7、ethodsF 1717, which is used to evaluate an entire construct assembledfrom many components and involves numerous interconnec-tions and several subassemblies.1.3 It is not the intention of these specifications and testmethods to define levels of performance or case-specificclinical performance for spi
8、nal components addressed by thisdocument. Insufficient knowledge to predict the consequencesof using any of these components in individual patients forspecific activities of daily living is available. Furthermore, it isnot the intention of this document to describe or specifyspecific designs for the
9、 individual components of systems usedin the surgical internal fixation of the spinal skeletal system.1.4 These specifications and test methods may not beappropriate for all types of spinal surgical fixation systems.Theuser is cautioned to consider the appropriateness of thisdocument in view of the
10、particular implant system and itspotential application.1.5 This document includes the following specifications andtest methods that are used in determining the spinal compo-nents mechanical performance characteristics:1.5.1 Specification for Metallic Spinal ScrewsAnnex A1.1.5.2 Specification for Met
11、allic Spinal PlatesAnnex A2.1.5.3 Specification for Metallic Spinal RodsAnnex A3.1.5.4 Test Method for Measuring the Static and FatigueBending Strength of Metallic Spinal ScrewsAnnex A4.1.6 Unless otherwise indicated, the values stated in SI unitsshall be regarded as the standard.1.7 This standard m
12、ay involve hazardous materials, opera-tions, and equipment. This standard does not purport toaddress all of the safety concerns, if any, associated with itsuse. It is the responsibility of the user of this standard toestablish appropriate safety and health practices and deter-mine the applicability
13、of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards: General2E4 Practices for Force Verification of Testing MachinesE 6 Terminology Relating to Methods of Mechanical Test-ingE 122 Practice for Calculating Sample Size to Estimate,With Specified Precision, the Average for
14、a Characteristicof a Lot or ProcessE 467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemE 1823 Terminology Relating to Fatigue and Fracture Test-ingE 1942 Guide for Evaluating Data Acquisition SystemsUsed in Cyclic Fatigue and Fracture Mechanics Tes
15、tingF 382 Specification and Test Method for Metallic BonePlatesF 543 Specification and Test Methods for Metallic MedicalBone Screws1These specifications and test methods are under the jurisdiction of ASTMCommittee F04 on Medical and Surgical Materials and Devices and is the directresponsibility of S
16、ubcommittee F04.25 on Spinal Devices.Current edition approved Nov. 15, 2007. Published November 2007. Originallyapproved in 2002. Last previous edition approved in 2002 as F 2193 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.o
17、rg. 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 Conshohocken, PA 19428-2959, United States.F 565 Practice for Care and Handling of Orthopedic Im-plants and
18、 InstrumentsF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1582 Terminology Relating to Spinal ImplantsF 1717 Test Methods for Spinal Implant Constructs in aVertebrectomy ModelF 1798 Guide for Evaluating the Static and Fatigue Proper-ties of Interconnection Mechanisms and S
19、ubassembliesUsed in Spinal Arthrodesis ImplantsF 1839 Specification for Rigid Polyurethane Foam for Useas a Standard Material for Testing Orthopedic Devices andInstruments2.2 ASTM Standards: Materials2D 4020 Specification for Ultra-High-Molecular-WeightPolyethylene Molding and Extrusion MaterialsF67
20、 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromi
21、um-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applicati
22、ons (UNSR56700)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1341 Specification for Unalloyed Titanium Wire UNSR50250, UNS R50400, UNS R50550, UNS R50700, forSurgical Implant
23、 Applications3F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2.3 ISO Standards:ISO 14630:1997 Non-active Surgical ImplantsGeneralRequirements43. Terminology3.1 Unless otherwise defined in these specifications and testmethods, the term
24、inology used in this document that is relatedto spinal implants will be in accordance with the definitions ofSpecification F 382, Specification F 543, and TerminologyF 1582.3.2 Unless otherwise defined in these specifications and testmethods, the terminology related to mechanical testing that isused
25、 in this document will be in accordance with the definitionsof Terminology E 6, Terminology E 1823, Specification F 382,Terminology F 1582, Test Methods F 1717, and Guide F 1798.3.3 TerminologyGeneral:3.3.1 expansion head screw, nthreaded anchor that isdesigned so that the head can be elastically de
26、formed, throughmechanical means, to establish an interconnection with anotherspinal construct element.3.3.2 locking screw, nthreaded anchor that is rigidlyconnected to the longitudinal element of the spinal construct.3.3.3 self-locking screw, nthreaded anchor design thatundergoes a deformation proce
27、ss at the end of the insertionprocess which results in the screws locking to the matingspinal construct element.3.3.4 shaft screw, nthreaded anchor having an unthreadedshank equal to its thread diameter.3.4 TerminologyGeometric:3.4.1 rod diameter (mm), nlength in mm of a chordpassing through the cen
28、ter of the rods cross-section.3.4.2 rod length (mm), noverall dimension measured inmm between the ends of a given rod.3.5 TerminologyMechanical/Structural:3.5.1 0.2 % offset displacement (mm), npermanent dis-placement equal to 0.002 times the test gage section length forthe specific test, in mm. The
29、 test gage section length is equal tothe bending moment arm for spinal screw tests. The test gagesection length is equal to the center span distance for spinalplate and rod tests where the loading rollers are directlycontacting the test specimen (Fig.A2.1 and Fig.A3.1). The testgage section length i
30、s equal to the unsupported distancebetween the ends of the extension segments for spinal plate androd tests where extension segments are used to load the testsample (Fig. A2.2). (distance 0B in Fig. A4.1).3.5.2 axial pull-out load (N), ntensile force in N requiredto fail or remove a screw from a mat
31、erial into which the screwhas been inserted when tested in accordance with Specificationand Test Methods F 543, Annex A3.3.5.3 bending fatigue runout moment (Nm), nvalue inN-m of the maximum moment that can be applied to a spinalcomponent where all of the tested samples have experienced2 500 000 loa
32、ding cycles without a failure at a specific R-ratio.3.5.4 bending moment arm, L (mm), ndistance in mmbetween the point where the test sample is gripped (typicallythe axis of the longitudinal element) and the line-of-action forthe applied force prior to any deformation of of the assembly.(See dimensi
33、on L of Fig. A4.2).3.5.5 bending stiffness, S (N/mm), nslope in N/mm of theinitial linear elastic portion of the load versus total displace-ment curve (slope of line 0m in Fig. A4.1).3.5.6 bending ultimate moment (Nm), nmaximum bend-ing moment in N-m that can be applied to a test sample. Thiswould c
34、orrespond to the bending moment at Point E in Fig.A4.1.3.5.7 bending yield moment (Nm), nbending moment inN-m necessary to produce a 0.2 % offset displacement in thespinal component. If the specimen fractures before the testreaches the 0.2 % offset displacement point, the bending yieldmoment shall b
35、e defined as the bending moment at fracture(point D in Fig. A4.1).3Withdrawn.4Available from International Organization for Standardization (ISO), 1 rue deVarembe, Case postale 56, CH-1211, Geneva 20, Switzerland.F 2193 02 (2007)23.5.8 exposed length (mm), nlinear distance measured inmm between the
36、surface of the test block that the screw isembedded in during the test and the location where the screwis anchored (typically the axis of the longitudinal element) inthe test fixture (see Fig. A4.2).3.5.9 gross failure, npermanent displacement resultingfrom fracture or plastic deformation in excess
37、of the yielddisplacement that renders the spinal component ineffective infulfilling its intended function.3.5.10 insertion depth (mm), nlinear advancement in mmof the screw into the test block measured relative to its seatedposition at the test blocks surface prior to testing.3.5.11 median bending f
38、atigue moment at N cycles (Nm),nvalue in N-m of the maximum moment that can be appliedto a spinal component for which 50 % of the test specimens ofa given sample can be expected to survive N loading cycles ata specific R-ratio.3.5.12 permanent displacement (mm), ntotal displace-ment in mm remaining
39、after the applied load has been removedfrom the test specimen.3.5.13 torsion yield moment (Nm), napplied torque inN-m at which the screw reaches its proportional limit whentested in accordance with Specification and Test MethodsF 543, Annex A1. The value is determined by using an offsetmethod with a
40、 2 angular offset.3.5.14 total displacement (mm), ndistance in mm, in thedirection of the applied load, which the load application pointhas moved relative to the zero load intercept of the initial linearsegment of the load versus displacement curve (point 0 in Fig.A4.1).3.5.15 yield displacement (mm
41、), ntotal displacement inmm associated with the bending yield strength (distance 0A inFig. A4.1).4. Significance and Use4.1 Spinal implant constructs are typically a compilation ofseveral components. Screws, plates, and rods are integralcomponents of many spinal implant constructs. These compo-nents
42、 are designed to transfer load between the bone and thelongitudinal or transverse element, or both. These specifica-tions and test methods identify specifications for such compo-nents and define standard equivalent test methods that can beused when evaluating different related component designs.4.2
43、Since the loading of spinal components in-vivo maydiffer from the loading configurations addressed in thesespecifications and test methods, the results obtained from thisdocument may not predict in-vivo performance of either thecomponents or the construct as a whole. Such tests can,however, be used
44、to compare different component designs interms of relevant mechanical performance characteristics.4.3 The performance-related mechanical characteristics de-termined by these specifications and test methods will supplythe user with information that may be used to predict themechanical performance of
45、different design variations of simi-lar (function and indication) spinal construct components.5. Requirements5.1 The following spinal components shall conform to therequirements of the listed standard specification:5.1.1 ScrewsStandard Specification for Metallic SpinalScrews (see Annex A1).5.1.2 Pla
46、tesStandard Specification for Metallic SpinalPlates (see Annex A2).5.1.3 RodsStandard Specification for Metallic SpinalRods (see Annex A3).6. Marking, Packaging, Labeling, and Handling6.1 Mark spinal components using the methods specified inPractice F 983.6.2 Markings on spinal components shall iden
47、tify the manu-facturer or distributor. When size permits, the followinginformation should be legibly marked on the spinal component(items listed in order of preference):6.2.1 Manufacturers name or logo,6.2.2 Material and, when applicable, theASTM designation,6.2.3 Catalog number,6.2.4 Manufacturing
48、lot number, and6.2.5 If the component is manufactured according to anASTM specification, the ASTM designation.6.3 Packaging shall be adequate to protect the spinal com-ponent during shipment.6.4 Package labeling for spinal components shall includethe following information:6.4.1 Manufacturer and prod
49、uct name,6.4.2 Catalog number,6.4.3 Lot or serial number,6.4.4 Material and, when applicable, the ASTM designationfor the material, and6.4.5 The sterility condition of the packaged spinal compo-nent.6.5 Spinal components shall be cared for and handledaccording to the requirements specified in Practice F 565.7. Materials7.1 The manufacturer is responsible for ensuring that mate-rials used to manufacture spinal components are suitable forimplanting into the body. Material suitability can be verifiedwith the methods described in ISO 14630
