【英文标准名称】:StandardGuideforMechanicalandFunctionalCharacterizationofNucleusDevices
【原文标准名称】:核装置的机械和功能特征表示的标准指南
【标准号】:ASTMF2789-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.25
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:dynamictests;nucleusdevice;spinalimplants;statictests
【摘要】:Nucleusdevicesaregenerallydesignedtoaugmentthemechanicalfunctionofnativedegeneratednucleusmaterialortoreplacetissuethathasbeenremovedduringasurgicalprocedure.Thisguideoutlinesmethodsforevaluatingmanydifferenttypesofdevices.Comparisonsbetweendevicesmustbemadecautiouslyandwithcarefulanalysis,takingintoaccounttheeffectsthatdesignandfunctionaldifferencescanhaveonthetestingconfigurationsandoverallperformance,andthepossibilitythatmechanicalfailuremaynotberelatedtoclinicalfailureandinversely,thatmechanicalsuccessmaynotberelatedtoclinicalsuccess.Thesetestsareconductedinvitrotoallowforanalysisofthemechanicalperformanceofthenucleusdeviceunderspecifictestingmodalities.Theloadsappliedmaydifferfromthecomplexloadingseeninvivo,andthereforetheresultsfromthesetestsmaynotdirectlypredictinvivoperformance.Thesetestsareusedtoquantifythestaticanddynamicpropertiesandperformanceofdifferentimplantdesigns.Themechanicaltestsareconductedinvitrousingsimplifiedloadsandmoments.Fatiguetestinginasimulatedbodyfluidorsalinemayhavefretting,aging,corroding,orlubricatingeffectsonthedeviceandtherebyaffecttherelativeperformanceoftesteddevices.Hence,thetestenvironmentandtheeffectofthatenvironment,whetherasimulatedbodyfluid,normalsalinebath(9gNaClper1000mLH2O),ordry,isanimportantcharacteristicofthetestandmustbereportedaccurately.Dynamictestingmethodsshouldbedesignedtoanswerthefollowingquestions,includingbutnotlimitedto:Doesthedevicestillfunctionasintendedaftercycling?Doesitretainadequateperformancecharacteristics(forexample,mechanicalandkinematicpropertiessuchasROM)?Didthedevicewearordegrade?Ifthereisevidenceofwearordegradationofthedevice,itshouldbeidentifiedandquantifiedwithreasonablemethodsgenerallyavailable.Theusershalldistinguishbetweenparticulatesgeneratedbythedeviceandparticulatesgeneratedbythetestmodelandfixturesiftechnicallyfeasible.1.1Thisguidedescribesvariousformsofnucleusreplacementandnucleusaugmentationdevices.Itfurtheroutlinesthetypesoftestingthatarerecommendedinevaluatingtheperformanceofthesedevices.1.2Biocompatibilityofthematerialsusedinanucleusreplacementdeviceisnotaddressedinthisguide.However,usersshouldinvestigatethebiocompatibilityoftheirdeviceseparately(seeX1.1).1.3Whileitisunderstoodthatexpulsionandendplatefracturesrepresentdocumentedclinicalfailures,thisguidedoesnotspecificallyaddressthem,althoughsomeofthefactorsthatrelatetoexpulsionhavebeenincluded(seeX1.3).1.4Multipletestsaredescribedinthisguide;however,theuserneednotusethemall.Itistheresponsibilityoftheuserofthisguidetodeterminewhichtestsareappropriateforthedevicesbeingtestedandtheirpotentialapplication.Sometestsmaynotbeapplicableforalltypesofdevices.Moreover,somenucleusdevicesmaynotbestableinalltestconfigurations.However,thisdoesnotnecessarilymeanthatthetestmethodsdescribedareunsuitable.1.5Thescienceofnucleusdevicedesignisstillveryyoungandincludestechnologythatischangingmorequicklythanthisguidecanbemodified.Therefore,theusermustcarefullyconsidertheapplicabilityofthisguidetotheuserx2019;sparticulardevice;theguidemaynotbeappropriateforeverydevice.Forexample,atthetimeofpublication,thisguidedoesnotaddressthenucleusreplacementandnucleusaugmentationdevi......
【中国标准分类号】:F60
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:英语
基本信息
| 标准名称： | Ｈ型孔系组合夹具多夹具基础件 窄角度板 |
| 中标分类： |
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| 发布日期： | 1992-01-23 |
| 实施日期： | 1992-03-01 |
| 首发日期： | 1900-01-01 |
| 作废日期： | 1900-01-01 |
| 出版日期： | 1900-01-01 |
| 页数： | 2页 |
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