1、Designation: F 2193 02Standard 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 adoption or, in the case
2、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 comprehensive reference for t
3、he 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 describe the size and
4、 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-related mechanical cha
5、racteristics ofspinal components.1.2 These specifications and test methods are a series ofstandards available for addressing the concerns related tosystems used in the surgical fixation of the spinal skeletalsystem. These specifications and test methods concentrate onthe individual components, which
6、 are found in many spinalfixation systems. If the user is interested in evaluating the nextlevel in the spinal fixation system chain, the interconnectionsbetween individual components and subassemblies (two ormore components), the user should consult Guide F 1798.Atthe highest level in this chain is
7、 Test Methods F 1717, which isused to evaluate an entire construct assembled from manycomponents and involves numerous interconnections and sev-eral subassemblies.1.3 It is not the intention of these specifications and testmethods to define levels of performance or case-specificclinical performance
8、for spinal components addressed by thisdocument. Insufficient knowledge is available to predict theconsequences of using any of these components in individualpatients for specific activities of daily living. Furthermore, it isnot the intention of this document to describe or specifyspecific designs
9、for the 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
10、 of the 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
11、 for Metallic 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 st
12、andard may 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 applic
13、ability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards: GeneralE4 Practices for Load Verification of Testing Machines2E 6 Terminology Relating to Methods of Mechanical Test-ing2E 122 Practice for Calculating Sample Size to Estimate,With a Specified Tolerable Error,
14、the Characteristic of aLot or Process3E 467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing System2E 1823 Terminology Relating to Fatigue and Fracture Test-ing2E 1942 Guide for Evaluating Data Acquisition SystemsUsed in Cyclic Fatigue and Fracture Mechanic
15、s Testing2F 382 Specification and Test Method for Metallic BonePlates41These specifications and test methods are under the jurisdiction of ASTMCommittee F04 on Medical and Surgical Materials and Devices and is the directresponsibility of Subcommittee F04.25 on Spinal Devices.Current edition approved
16、 June 10, 2002. Published August 2002.2Annual Book of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards, Vol 14.02.4Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 543 Specification a
17、nd Test Methods for Metallic MedicalBone Screws4F 565 Practice for Care and Handling of Orthopaedic Im-plants and Instruments4F 983 Practice for Permanent Marking of Orthopedic Im-plant Components4F 1582 Terminology Relating to Spinal Implants4F 1717 Test Methods for Static and Fatigue for SpinalImp
18、lant Constructs in a Vertebrectomy Model4F 1798 Guide for Evaluating the Static and Fatigue Proper-ties of Interconnections Mechanisms and SubassembliesUsed in Spinal Arthrodesis Implants4F 1839 Specification for Rigid Polyurethane Foam for Useas a Standard Material for Testing Orthopaedic Devicesan
19、d Instruments42.2 ASTM Standards: MaterialsF67 Specification for Unalloyed Titanium (UNS R50250,R50400, R 50550, R50700) for Surgical Implant Applica-tions4F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNSR56401) for Surgical Implant Applications4F
20、138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)4F 1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications4F 1314 Specification for Wrought Nitrogen Strengthened-22Chromium-12.5Ni
21、ckel-5Manganese-2.5MolybdenumStainless Steel Bar and Wire for Surgical Implants (UNSS20910)4F 1341 Specification for Unalloyed Titanium Wire (UNSR50250) for Surgical Implant Applications4F 1472 Specification for Wrought Titanium Ti-6Al-4V Al-loy for Surgical Implant Applications (UNS R56400)42.3 ISO
22、 Standards:ISO 14630:1997 Non-active Surgical ImplantsGeneralRequirements53. Terminology3.1 Unless otherwise defined in these specifications and testmethods, the terminology used in this document that is relatedto spinal implants will be in accordance with the definitions ofSpecification F 382, Spec
23、ification F 543, and TerminologyF 1582.3.2 Unless otherwise defined in these specifications and testmethods, the terminology related to mechanical testing that isused in this document will be in accordance with the definitionsof Terminology E 6, Terminology E 1823, Specification F 382,Terminology F
24、1582, Test Methods F 1717, and Guide F 1798.3.3 TerminologyGeneral:3.3.1 expansion head screwa threaded anchor that isdesigned so that the head can be elastically deformed, throughmechanical means, to establish an interconnection with anotherspinal construct element.3.3.2 locking screwa threaded anc
25、hor that is rigidly con-nected to the longitudinal element of the spinal construct.3.3.3 self-locking screwa threaded anchor design thatundergoes a deformation process at the end of the insertionprocess which results in the screws locking to the matingspinal construct element.3.3.4 shaft screwa thre
26、aded anchor having an unthreadedshank equal to its thread diameter.3.4 TerminologyGeometric:3.4.1 rod diameter (mm)the length of a chord passingthrough the center of the rods cross-section.3.4.2 rod length (mm)the overall dimension measuredbetween the ends of a given rod.3.5 TerminologyMechanical/St
27、ructural:3.5.1 0.2 % offset displacement (mm)a permanent dis-placement equal to 0.002 times the test gage section length forthe specific test. The test gage section length is equal to thebending moment arm for spinal screw tests. The test gagesection length is equal to the center span distance for s
28、pinalplate and rod tests where the loading rollers are directlycontacting the test specimen (Fig.A2.1 and Fig.A3.1). The testgage section length is equal to the unsupported distancebetween the ends of the extension segments for spinal plate androd tests where extension segments are used to load the
29、testsample (Fig. A2.2). (distance 0B in Fig. A4.1).3.5.2 axial pull-out load (N)the tensile force required tofail or remove a screw from a material into which the screw hasbeen inserted when tested in accordance with Specification andTest Methods F 543, Annex A3.3.5.3 bending fatigue runout moment (
30、Nm)the value ofthe maximum moment that can be applied to a spinal compo-nent where all of the tested samples have experienced2 500 000 loading cycles without a failure at a specific R-ratio.3.5.4 bending moment arm, L (mm)the distance betweenthe point where the test sample is gripped (typically the
31、axis ofthe longitudinal element) and the line-of-action for the appliedforce prior to any deformation of of the assembly. (Seedimension L of Fig. A4.2).3.5.5 bending stiffness, S (N/mm)the slope of the initiallinear elastic portion of the load versus total displacementcurve (slope of line 0m in Fig.
32、 A4.1).3.5.6 bending ultimate moment (Nm)the maximum bend-ing moment that can be applied to a test sample. This wouldcorrespond to the bending moment at Point E in Fig. A4.1.3.5.7 bending yield moment (Nm)the bending momentnecessary to produce a 0.2 % offset displacement in the spinalcomponent. If t
33、he specimen fractures before the test reachesthe 0.2 % offset displacement point, the bending yield momentshall be defined as the bending moment at fracture (point D inFig. A4.1).3.5.8 exposed length (mm)the linear distance measuredbetween the surface of the test block that the screw isembedded in d
34、uring the test and the location where the screwis anchored (typically the axis of the longitudinal element) inthe test fixture (see Fig. A4.2).5Available from International Organization for Standardization (ISO), 1 rue deVarembe, Case postale 56, CH-1211, Geneva 20, Switzerland.F21930223.5.9 gross f
35、ailurepermanent displacement resulting fromfracture or plastic deformation in excess of the yield displace-ment that renders the spinal component ineffective in fulfillingits intended function.3.5.10 insertion depth (mm)the linear advancement of thescrew into the test block measured relative to its
36、seated positionat the test blocks surface prior to testing.3.5.11 median bending fatigue moment at N cycles (Nm)the value of the maximum moment that can be applied to aspinal component for which 50 % of the test specimens of agiven sample can be expected to survive N loading cycles at aspecific R-ra
37、tio.3.5.12 permanent displacement (mm)the total displace-ment remaining after the applied load has been removed fromthe test specimen.3.5.13 torsion yield moment (Nm)the applied torque atwhich the screw reaches its proportional limit when tested inaccordance with Specification and Test Methods F 543
38、, AnnexA1. The value is determined by using an offset method with a2 angular offset.3.5.14 total displacement (mm)the distance, in the direc-tion of the applied load, which the load application point hasmoved relative to the zero load intercept of the initial linearsegment of the load versus displac
39、ement curve (point 0 in Fig.A4.1).3.5.15 yield displacement (mm)the total displacementassociated with the bending yield strength (distance 0A in Fig.A4.1).4. Significance and Use4.1 Spinal implant constructs are typically a compilation ofseveral components. Screws, plates, and rods are integralcompo
40、nents of many spinal implant constructs. These compo-nents 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 beuse
41、d when evaluating different related component designs.4.2 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
42、the construct as a whole. Such tests can,however, be used 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
43、 that may be used to predict themechanical performance of 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 Specif
44、ication for Metallic SpinalScrews (see Annex A1).5.1.2 PlatesStandard 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 inP
45、ractice F 983.6.2 Markings on spinal components shall identify 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, the
46、ASTM designation,6.2.3 Catalog number,6.2.4 Manufacturing 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 in
47、cludethe following information:6.4.1 Manufacturer and product 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 an
48、d 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.
49、7.2 The manufacturer should also consider the materials ofother spinal components within the spinal implant constructwhen selecting a material.Avoid the mixing of materials withina spinal implant construct in order to prevent the developmentof undesirable corrosion conditions.7.3 All spinal components that are made of materials thathave an ASTM standard designation shall meet those require-ments given in the ASTM standards. The following is a list ofsome materials that have been used for spinal components:7.3.1 Unalloyed Titanium (see Specificati
