ASTM F1798-1997(2003) 脊椎关节固定术植入用互连接装置和子配件的静态和疲劳特性评价的标准指南
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【英文标准名称】:StandardGuideforEvaluatingtheStaticandFatiguePropertiesofInterconnectionMechanismsandSubassembliesUsedinSpinalArthrodesisImplants
【原文标准名称】:脊椎关节固定术植入用互连接装置和子配件的静态和疲劳特性评价的标准指南
【标准号】:ASTMF1798-1997(2003)
【标准状态】:现行
【国别】:
【发布日期】:1997
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.25
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:脊椎关节固定术植入;子配件;夹送量;用尽;互连接
【英文主题词】:grippingcapacity;interconnection;runout;spinalarthrodesisimplant;subassembly
【摘要】:Spinalimplantsaregenerallycomposedofseveralcomponentsthat,whenconnectedtogether,formaspinalimplantconstruct.Spinalimplantconstructsaredesignedtoprovidesomestabilitytothespinewhilearthrodesistakesplace.Thisguideoutlinesstandardizedevaluationsofdifferentinterconnectionmechanismssothatcomparisonbetweendifferentdesignsisfacilitated.Comparisonsmustbemadecautiouslyandwithcarefulanalysis,takingintoaccounttheeffectsthatdesigndifferencescanhaveontheloadingconfigurations.Thisguideisusedtoquantifythestaticandfatiguepropertiesofdifferentimplantinterconnectiondesigns.Themechanicaltestsareconductedinvitrousingsimplified,unidirectionalloadsandmoments.Fatiguetestinginasimulatedbodyfluidorsalinemayhaveafretting,corrosive,orlubricationeffectontheinterconnectionandtherebyaffecttherelativeperformanceoftesteddevices.Hence,thetestenvironment,whetherasimulatedbodyfluid,saline(9gNaClper1000mLH2O),withasalinedrip,ordry,isanimportantcharacteristicofthetestandmustbereportedaccurately.Theloadingofspinalimplantconstructsinvivowill,ingeneral,differfromtheloadingconfigurationsusedinthisguide.Theresultsobtainedherecannotbeuseddirectlytopredictinvivoperformance.However,theresultscanbeusedtocomparedifferentcomponentdesignsintermsofrelativemechanicalparameters.1.1Thisguidecoversthemeasurementofuniaxialstaticandfatiguestrength,andresistancetolooseningofthecomponentinterconnectionmechanismsofspinalarthrodesisimplants.1.2Thepurposeofthisguideistoprovideameansofmechanicallycharacterizingdifferentdesignsofspinalimplantinterconnections.Ultimately,thevariouscomponentsandinterconnectionsshouldbecombinedforstaticandfatiguetestingofthespinalimplantconstruct.Itisnottheintentionofthisguidetoaddresstheanalysisofspinalimplantconstructsorsubconstructsortodefinelevelsofperformanceofspinalimplantsasinsufficientknowledgeisavailabletopredicttheconsequencesoftheuseofparticularspinalimplantdesigns.1.3Thisguidesetsoutdefinitionsforuseinmeasuringthestrengthofcomponentinterconnectionsofspinalimplants,possibletestmethodsthemselves,andthereportingoftestresults.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:
【原文标准名称】:脊椎关节固定术植入用互连接装置和子配件的静态和疲劳特性评价的标准指南
【标准号】:ASTMF1798-1997(2003)
【标准状态】:现行
【国别】:
【发布日期】:1997
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.25
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:脊椎关节固定术植入;子配件;夹送量;用尽;互连接
【英文主题词】:grippingcapacity;interconnection;runout;spinalarthrodesisimplant;subassembly
【摘要】:Spinalimplantsaregenerallycomposedofseveralcomponentsthat,whenconnectedtogether,formaspinalimplantconstruct.Spinalimplantconstructsaredesignedtoprovidesomestabilitytothespinewhilearthrodesistakesplace.Thisguideoutlinesstandardizedevaluationsofdifferentinterconnectionmechanismssothatcomparisonbetweendifferentdesignsisfacilitated.Comparisonsmustbemadecautiouslyandwithcarefulanalysis,takingintoaccounttheeffectsthatdesigndifferencescanhaveontheloadingconfigurations.Thisguideisusedtoquantifythestaticandfatiguepropertiesofdifferentimplantinterconnectiondesigns.Themechanicaltestsareconductedinvitrousingsimplified,unidirectionalloadsandmoments.Fatiguetestinginasimulatedbodyfluidorsalinemayhaveafretting,corrosive,orlubricationeffectontheinterconnectionandtherebyaffecttherelativeperformanceoftesteddevices.Hence,thetestenvironment,whetherasimulatedbodyfluid,saline(9gNaClper1000mLH2O),withasalinedrip,ordry,isanimportantcharacteristicofthetestandmustbereportedaccurately.Theloadingofspinalimplantconstructsinvivowill,ingeneral,differfromtheloadingconfigurationsusedinthisguide.Theresultsobtainedherecannotbeuseddirectlytopredictinvivoperformance.However,theresultscanbeusedtocomparedifferentcomponentdesignsintermsofrelativemechanicalparameters.1.1Thisguidecoversthemeasurementofuniaxialstaticandfatiguestrength,andresistancetolooseningofthecomponentinterconnectionmechanismsofspinalarthrodesisimplants.1.2Thepurposeofthisguideistoprovideameansofmechanicallycharacterizingdifferentdesignsofspinalimplantinterconnections.Ultimately,thevariouscomponentsandinterconnectionsshouldbecombinedforstaticandfatiguetestingofthespinalimplantconstruct.Itisnottheintentionofthisguidetoaddresstheanalysisofspinalimplantconstructsorsubconstructsortodefinelevelsofperformanceofspinalimplantsasinsufficientknowledgeisavailabletopredicttheconsequencesoftheuseofparticularspinalimplantdesigns.1.3Thisguidesetsoutdefinitionsforuseinmeasuringthestrengthofcomponentinterconnectionsofspinalimplants,possibletestmethodsthemselves,andthereportingoftestresults.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:10P.;A4
【正文语种】:
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