1、Designation:F278910(Reapproved 2015)Standard Guide forMechanical and Functional Characterization of NucleusDevices1This standard is issued under the fixed designation F2789;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of
2、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 guide describes various forms of nucleus replace-ment and nucleus augmentation devices.It further outlines thetypes of
3、 testing that are recommended in evaluating theperformance of these devices.1.2 Biocompatibility of the materials used in a nucleusreplacement device is not addressed in this guide.However,users should investigate the biocompatibility of their deviceseparately(see X1.1).1.3 While it is understood th
4、at expulsion and endplatefractures represent documented clinical failures,this guidedoes not specifically address them,although some of thefactors that relate to expulsion have been included(see X1.3).1.4 Multiple tests are described in this guide;however,theuser need not use them all.It is the resp
5、onsibility of the user ofthis guide to determine which tests are appropriate for thedevices being tested and their potential application.Some testsmay not be applicable for all types of devices.Moreover,somenucleus devices may not be stable in all test configurations.However,this does not necessaril
6、y mean that the test methodsdescribed are unsuitable.1.5 The science of nucleus device design is still very youngand includes technology that is changing more quickly thanthis guide can be modified.Therefore,the user must carefullyconsider the applicability of this guide to the users particulardevic
7、e;the guide may not be appropriate for every device.Forexample,at the time of publication,this guide does not addressthe nucleus replacement and nucleus augmentation devices thatare designed to be partially or completely resorbable in thebody.However,some of the test recommended in this guidemay be
8、applicable to evaluate such devices.It has not beendemonstrated that mechanical failure of nucleus devices isrelated to adverse clinical results.Therefore this standardshould be used with care in evaluating proposed nucleusdevices.1.6 This guide is not intended to be a performance standard.It is the
9、 responsibility of the user of this guide to characterizethe safety and effectiveness of the nucleus device underevaluation.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.Angular measurements may be reported in eitherdegrees
10、 or radians.1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Refe
11、renced Documents2.1 ASTM Standards:2D2990 Test Methods for Tensile,Compressive,and FlexuralCreep and Creep-Rupture of PlasticsD6204 Test Method for RubberMeasurement of Unvulca-nized Rheological Properties Using Rotorless Shear Rhe-ometersE6 Terminology Relating to Methods of Mechanical TestingE111
12、Test Method for Youngs Modulus,Tangent Modulus,and Chord ModulusE132 Test Method for Poissons Ratio at Room TemperatureE328 Test Methods for Stress Relaxation for Materials andStructuresE1823 Terminology Relating to Fatigue and Fracture TestingF561 Practice for Retrieval and Analysis of MedicalDevic
13、es,and Associated Tissues and FluidsF1582 Terminology Relating to Spinal ImplantsF1714 Guide for Gravimetric WearAssessment of ProstheticHip Designs in Simulator DevicesF1877 Practice for Characterization of ParticlesF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical DevicesF2
14、267 Test Method for Measuring Load Induced Subsidence1This 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 May 1,2015.Published July 2015.Original
15、ly approvedin 2010.Last previous edition approved in 2010 as F2789 10.DOI:10.1520/F2789-10R15.2For 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 Summ
16、ary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 of Intervertebral Body Fusion Device Under Static AxialCompressionF2346 Test Methods for Static and Dynamic Characteriza-tion of Spinal Artificial DiscsF2423 Guide for Functional,Kinematic,and Wear Assess-ment of Total Disc Prostheses2.2 Other Standards:3ISO 10993 Biological Evaluation of Medical Devices:Parts120ISO 181921 Implants for SurgeryWear of Total Int