ASTM_F_2624_-_12.pdf

Designation:F262412Standard Test Method forStatic,Dynamic,and Wear Assessment of Extra-DiscalSingle Level Spinal Constructs1This standard is issued under the fixed designation F2624;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 This test method describes methods to assess the staticand dynamic properties of single level spinal constructs.1.2 An option for assessing wear using a weight loss methodand a dimensional analysis is given.This method,describedherein,is used for the analysis of devices intended for motionpreservation,using testing medium as defined in this standard(6.1).1.3 This test method is not intended to address any potentialfailure mode as it relates to the fixation of the device to its bonyinterfaces.1.4 It is the intent of this test method to enable single levelextra-discal spinal constructs with regard to kinematic,functional,and wear characteristics when tested under thespecified conditions.1.5 This test method is not intended to address facetarthroplasty devices.1.6 In order that the data be reproducible and comparablewithin and between laboratories,it is essential that uniformprocedures be established.This test method is intended tofacilitate uniform testing methods and data reporting.1.7 The motion profiles specified by this test method do notnecessarily accurately reproduce those occurring in vivo.Rather this method provides useful boundary/endpoint condi-tions for evaluating implant designs in a functional manner.1.8 This test method is not intended to be a performancestandard.It is the responsibility of the user of this test methodto characterize the safety and effectiveness of the device underevaluation.1.9 Multiple test methods are included in this standard.However,it must be noted that the user is not obligated to testusing all of the described methods.Instead,the user shouldonly select test methods that are appropriate for a particulardevice design.In most instances,only a subset of the hereindescribed test methods will be required.1.10 The values stated in SI units are to be regarded as thestandard with the exception of angular measurements,whichmay be reported in either degrees or radians.No other units ofmeasurement are included in this standard.1.11 This test method does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this test method to establishappropriate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E2309 Practices for Verification of Displacement MeasuringSystems and Devices Used in Material Testing MachinesF561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF1714 Guide for Gravimetric WearAssessment of ProstheticHip Designs in Simulator DevicesF1717 Test Methods for Spinal Implant Constructs in aVertebrectomy ModelF1877 Practice for Characterization of ParticlesF2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAirF2423 Guide for Functional,Kinematic,and Wear Assess-ment of Total Disc Prostheses3.Terminology3.1 All terminology is consistent with the referencedstandards,unless otherwise stated.3.2 Definitions:3.2.1 center of rotation(COR)the point about which thesimulated vertebral bodies rotate in performing the range ofmotion(ROM)specified in this test method.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved Dec.1,2012.Published February 2013.Originallyapproved in 2007.Last previous edition approved in 2007 as F1587 07.DOI:10.1520/F2624-12.2For 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 3.2.2 compressive bending stiffness(N/mm)the compres-sive bending yield force divided by elastic displacement(seethe initial slope of line BC in Fig.1).3.2.3 compressive bending ultimate load(N)the maxi-mum compressive force in the X-Z plane applied to a spinalimplant assembly(see the force at Point E in Fig.1).Theultimate load should be a function of the device and not of theload cell or testing machine.3.2.4 compressive bending yield load(N)the compressivebending force in the X-Z plane necessary to produce apermanent deformation equal to 0.020 times the active lengthof the longitudinal element(see the force at Point D in Fig.1