1、Designation: F2193 14F2193 18Standard 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
2、 case of 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 to provide a comprehensive reference
3、 for the components of systemsused in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material,labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used todescribe the si
4、ze and other physical characteristics of spinal components and performance definitions related to the performanceof spinal components. Additionally, the specifications and test methods establish performance requirements and standard testmethods to consistently measure performance-related mechanical
5、characteristics of spinal components.1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation ofthe spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found inmany spina
6、l fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, theinterconnections between individual components and subassemblies (two or more components), the user should consult GuideF1798.At the highest level in this chain is Test Methods F1717, w
7、hich is used to evaluate an entire construct assembled from manycomponents and involves numerous interconnections and several subassemblies.1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinicalperformance for spinal components
8、addressed by this document. Insufficient knowledge to predict the consequences of using anyof these components in individual patients for specific activities of daily living is available. Furthermore, it is not the intention ofthis document to describe or specify specific designs for the individual
9、components of systems used in the surgical internal fixationof the spinal skeletal system.1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user iscautioned to consider the appropriateness of this document in view of the particula
10、r implant system and its potential application.1.5 This document includes the following specifications and test methods that are used in determining the spinal componentsmechanical performance characteristics:1.5.1 Specification for Metallic Spinal ScrewsAnnex A1.1.5.2 Specification for Metallic Spi
11、nal PlatesAnnex A2.1.5.3 Specification for Metallic Spinal RodsAnnex A3.1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal ScrewsAnnex A4.1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.1.7 This standard may invo
12、lve hazardous materials, operations, and equipment. This standard does not purport to address allof the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriatesafety safety, health, and healthenvironmental practices and determi
13、ne the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations is
14、suedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.1 These specifications and test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and isare the directresponsibility of Subcommittee F04.25 on Spinal Devices.Current e
15、dition approved Oct. 1, 2014Feb. 1, 2018. Published November 2014March 2018. Originally approved in 2002. Last previous edition approved in 20072014 asF2193 02 (2007).F2193 14. DOI: 10.1520/F2193-14.10.1520/F2193-18.This document is not an ASTM standard and is intended only to provide the user of an
16、 ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as publis
17、hed by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12. Referenced Documents2.1 ASTM Standards: General2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to
18、 Methods of Mechanical TestingE122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcessE467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing SystemE1823 Terminology Relating to Fatigu
19、e and Fracture TestingE1942 Guide for Evaluating Data Acquisition Systems Used in Cyclic Fatigue and Fracture Mechanics TestingF382 Specification and Test Method for Metallic Bone PlatesF543 Specification and Test Methods for Metallic Medical Bone ScrewsF565 Practice for Care and Handling of Orthope
20、dic Implants and InstrumentsF983 Practice for Permanent Marking of Orthopaedic Implant ComponentsF1582 Terminology Relating to Spinal ImplantsF1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelF1798 Test Method for Evaluating the Static and Fatigue Properties of Interconnection
21、 Mechanisms and Subassemblies Usedin Spinal Arthrodesis ImplantsF1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices andInstrumentsF2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentF294
22、3 Guide for Presentation of End User Labeling Information for Musculoskeletal Implants2.2 ASTM Standards: Materials2D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion MaterialsF67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250,
23、 UNS R50400, UNS R50550, UNSR50700)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S3167
24、3)F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium13 Nickel
25、5 Manganese2.5 Molybdenum StainlessSteel Alloy Bar and Wire for Surgical Implants (UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)2.3 ISO Standards:ISO 14630 Non-active Surgical ImplantsGeneral Requirements33. Terminology3.
26、1 Unless otherwise defined in these specifications and test methods, the terminology used in this document that is related tospinal implants will be in accordance with the definitions of Specification F382, Specification F543, and Terminology F1582.3.2 Unless otherwise defined in these specification
27、s and test methods, the terminology related to mechanical testing that is usedin this document will be in accordance with the definitions of Terminology E6, Terminology E1823, Specification F382,Terminology F1582, Test Methods F1717, and Guide F1798.3.3 TerminologyGeneral:3.3.1 expansion head screw,
28、 nthreaded anchor that is designed so that the head can be elastically deformed, throughmechanical means, to establish an interconnection with another spinal construct element.3.3.2 locking screw, nthreaded anchor that is rigidly connected to the longitudinal element of the spinal construct.3.3.3 se
29、lf-locking screw, nthreaded anchor design that undergoes a deformation process at the end of the insertion processwhich results in the screws locking to the mating spinal construct element.3.3.4 shaft screw, nthreaded anchor having an unthreaded shank equal to its thread diameter.3.4 TerminologyGeom
30、etric:3.4.1 rod diameter (mm), nlength in mm of a chord passing through the center of the rods cross-section.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the stan
31、dards Document Summary page on the ASTM website.3 Available from International Organization for Standardization (ISO), 1 rue de Varembe, Case postale 56, CH-1211, Geneva 20, Switzerland.F2193 1823.4.2 rod length (mm), noverall dimension measured in mm between the ends of a given rod.3.5 TerminologyM
32、echanical/Structural:3.5.1 0.2 % offset displacement (mm), npermanent displacement equal to 0.002 times the test gage section length for thespecific test, in mm. The test gage section length is equal to the bending moment arm for spinal screw tests. The test gage sectionlength is equal to the center
33、 span distance for spinal plate and rod tests where the loading rollers are directly contacting the testspecimen (Fig. A2.1 and Fig. A3.1). The test gage section length is equal to the unsupported distance between the ends of theextension segments for spinal plate and rod tests where extension segme
34、nts are used to load the test sample (Fig. A2.2). (distance0B in Fig. A4.1).3.5.2 axial pull-out load (N), ntensile force in N required to fail or remove a screw from a material into which the screw hasbeen inserted when tested in accordance with Specification and Test Methods F543, Annex A3.3.5.3 b
35、ending fatigue runout moment (Nm), nvalue in N-m of the maximum moment that can be applied to a spinalcomponent where all of the tested samples have experienced 2 500 000 loading cycles without a failure at a specific R-ratio.3.5.4 bending moment arm, L (mm), ndistance in mm between the point where
36、the test sample is gripped (typically the axisof the longitudinal element) and the line-of-action for the applied force prior to any deformation of of the assembly. (See dimensionL of Fig. A4.2).3.5.5 bending stiffness, S (N/mm), nslope in N/mm of the initial linear elastic portion of the load versu
37、s total displacementcurve (slope of line 0m in Fig. A4.1).3.5.6 bending ultimate moment (Nm), nmaximum bending moment in N-m 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), n bending moment in N-m necessary to
38、produce a 0.2 % offset displacement in the spinalcomponent. If the specimen fractures before the test reaches the 0.2 % offset displacement point, the bending yield moment shallbe defined as the bending moment at fracture (point D in Fig. A4.1).3.5.8 exposed length (mm), nlinear distance measured in
39、 mm between the surface of the test block that the screw is embeddedin during the test and the location where the screw is anchored (typically the axis of the longitudinal element) in the test fixture(see Fig. A4.2).3.5.9 gross failure, npermanent displacement resulting from fracture or plastic defo
40、rmation in excess of the yielddisplacement that renders the spinal component ineffective in fulfilling its intended function.3.5.10 insertion depth (mm), nlinear advancement in mm of the screw into the test block measured relative to its seatedposition at the test blocks surface prior to testing.3.5
41、.11 median bending fatigue moment at N cycles (Nm), nvalue in N-m of the maximum moment that can be applied to aspinal component for which 50 % of the test specimens of a given sample can be expected to survive N loading cycles at a specificR-ratio.3.5.12 permanent displacement (mm), ntotal displace
42、ment in mm remaining after the applied load has been removed from thetest specimen.3.5.13 torsion yield moment (Nm), n applied torque in N-m at which the screw reaches its proportional limit when tested inaccordance with Specification and Test Methods F543, Annex A1. The value is determined by using
43、 an offset method with a 2angular offset.3.5.14 total displacement (mm), ndistance in mm, in the direction of the applied load, which the load application point hasmoved relative to the zero load intercept of the initial linear segment of the load versus displacement curve (point 0 in Fig. A4.1).3.5
44、.15 yield displacement (mm), ntotal displacement in mm associated with the bending yield strength (distance 0A in Fig.A4.1).4. Significance and Use4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integralcomponents of many spinal implant c
45、onstructs. These components are designed to transfer load between the bone and thelongitudinal or transverse element, or both. These specifications and test methods identify specifications for such components anddefine standard equivalent test methods that can be used when evaluating different relat
46、ed component designs.4.2 Since the loading of spinal components in-vivo may differ from the loading configurations addressed in these specificationsand test methods, the results obtained from this document may not predict in-vivo performance of either the components or theconstruct as a whole. Such
47、tests can, however, be used to compare different component designs in terms of relevant mechanicalperformance characteristics.4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the userwith information that may be used to predict th
48、e mechanical performance of different design variations of similar (function andindication) spinal construct components.F2193 1835. Requirements5.1 The following spinal components shall conform to the requirements of the listed standard specification:5.1.1 ScrewsStandard Specification for Metallic S
49、pinal Screws (see Annex A1).5.1.2 PlatesStandard Specification for Metallic Spinal Plates (see Annex A2).5.1.3 RodsStandard Specification for Metallic Spinal Rods (see Annex A3).6. Marking, Packaging, Labeling, and Handling6.1 Mark spinal components using the methods specified in Practice F983.6.2 Markings on spinal components shall identify the manufacturer or distributor. When size permits, the following informationshould be legibly marked on the spinal component (items listed in order of preference):6.2.1 Manufacturers name or l
