1、Designation: F2193 14Standard Specifications and Test Methods forComponents Used in the Surgical Fixation of the SpinalSkeletal System1This standard is issued under the fixed designation F2193; the number immediately following the designation indicates the year oforiginal adoption or, in the case of
2、 revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () 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 the
3、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 ot
4、her physicalcharacteristics of spinal components and performance defini-tions related to the performance of spinal components.Additionally, the specifications and test methods establishperformance requirements and standard test methods to con-sistently measure performance-related mechanical characte
5、ris-tics of spinal 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 foundin many spinal fixat
6、ion 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 F1798. At the highest level in this chain is Test MethodsF1717, which is
7、 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 spinal components address
8、ed 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 individual components
9、 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 particular implant sy
10、stem 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 Metallic Spinal PlatesAn
11、nex 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 may involve hazardous
12、materials,operations, 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 of regulatory limitatio
13、ns prior to use.2. Referenced Documents2.1 ASTM Standards: General2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE122 Practice for Calculating Sample Size to Estimate, WithSpecified Precision, the Average for a Characteristic of aLot o
14、r ProcessE467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemE1823 Terminology Relating to Fatigue and Fracture TestingE1942 Guide for Evaluating Data Acquisition Systems Usedin Cyclic Fatigue and Fracture Mechanics TestingF382 Specification and Tes
15、t Method for Metallic Bone PlatesF543 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 Subcommittee F04.25 on Spinal De
16、vices.Current edition approved Oct. 1, 2014. Published November 2014. Originallyapproved in 2002. Last previous edition approved in 2007 as F2193 02 (2007).DOI: 10.1520/F2193-14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.
17、For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F565 Practice for Care and Handling of Orthopedic Implantsand Instrum
18、entsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1582 Terminology Relating to Spinal ImplantsF1717 Test Methods for Spinal Implant Constructs in aVertebrectomy ModelF1798 Test Method for Evaluating the Static and FatigueProperties of Interconnection Mechanisms and Subassem-
19、blies Used in Spinal Arthrodesis ImplantsF1839 Specification for Rigid Polyurethane Foam for Use asa Standard Material for Testing Orthopaedic Devices andInstrumentsF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance EnvironmentF2943 Guide for Presentation
20、of End User Labeling Infor-mation for Musculoskeletal Implants2.2 ASTM Standards: Materials2D4020 Specification for Ultra-High-Molecular-Weight Poly-ethylene Molding and Extrusion MaterialsF67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550
21、, UNS R50700)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F648 Specification fo
22、r Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 Molybden
23、umStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2.3 ISO Standards:ISO 14630 Non-active Surgical ImplantsGeneral Require-ments33. Terminology3.1 Unless otherwise defin
24、ed in these specifications and testmethods, the terminology used in this document that is relatedto spinal implants will be in accordance with the definitions ofSpecification F382, Specification F543, and TerminologyF1582.3.2 Unless otherwise defined in these specifications and testmethods, the term
25、inology related to mechanical testing that isused in this document will be in accordance with the definitionsof Terminology E6, Terminology E1823, Specification F382,Terminology F1582, Test Methods F1717, and Guide F1798.3.3 TerminologyGeneral:3.3.1 expansion head screw, nthreaded anchor that isdesi
26、gned so that the head can be elastically deformed, 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 anch
27、or 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 screw, nthreaded anchor having an unthreadedshank equal to its thread diameter.3.4 TerminologyGeometric:3.4.1 rod diameter (mm), nlen
28、gth in mm of a chordpassing through the center 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 sect
29、ion length forthe specific test, in mm. The 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 a
30、nd 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 testsample (Fig. A2.2). (distance 0B in Fig. A4.1).3.5.2 axial pull-out load (N), ntensile force in N r
31、equiredto fail or remove a screw from a material into which the screwhas been inserted when tested in accordance with Specificationand Test Methods F543, 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 te
32、sted samples have experienced2 500 000 loading 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 d
33、eformation of of the assembly.(See dimension 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 ca
34、n be applied to a test sample. Thiswould correspond to the bending moment at Point E in Fig.A4.1.3.5.7 bending yield moment (Nm), n bending moment inN-m necessary to produce a 0.2 % offset displacement in thespinal component. If the specimen fractures before the test3Available from International Org
35、anization for Standardization (ISO), 1 rue deVarembe, Case postale 56, CH-1211, Geneva 20, Switzerland.F2193 142reaches the 0.2 % offset displacement point, the bending yieldmoment shall be defined as the bending moment at fracture(point D in Fig. A4.1).3.5.8 exposed length (mm), nlinear distance me
36、asured inmm between the 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 plasti
37、c deformation in excess 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
38、.3.5.11 median bending fatigue 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 displa
39、cementin mm remaining after the applied load has been removed fromthe test specimen.3.5.13 torsion yield moment (Nm), n applied torque inN-m at which the screw reaches its proportional limit whentested in accordance with Specification and Test MethodsF543, Annex A1. The value is determined by using
40、an offsetmethod with a 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
41、yield displacement (mm), 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 constru
42、cts. 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 beused when evaluating different related
43、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 the construct as a whole. Such tests
44、 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 that may be used to predict themech
45、anical 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 Specification for Metallic SpinalScrews (s
46、ee 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 inPractice F983.6.2 Markings on spinal
47、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, theASTM designation,6.2.3 Catalog number
48、,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 includethe following information:6.4.1
49、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 Package labeling may elect to follow guidance in GuideF2943 for package label presentation.6.6 Product labeling may include marking for safety in theMagnetic Resonance Environment in accordance with PracticeF2503.6.7 Spinal components shall be cared for and handledaccording to the requirements specified in Practice F5
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