ASTM_F_2193_-_14.pdf

Designation:F219314Standard 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 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 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 other 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 characteris-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 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 F1798.At the highest level in this chain is Test MethodsF1717,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 spinal 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 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 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 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 standard may involve hazardous 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 limitations 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 or 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 Test 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 Devices.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.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 States1 F565 Practice for Care