ASTM F1877-2005(2010) 粒度特征标准实施规程
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【英文标准名称】:StandardPracticeforCharacterizationofParticles
【原文标准名称】:粒度特征标准实施规程
【标准号】:ASTMF1877-2005(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2005
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;morphology;particles;SEM;weardebris;Biocompatibility;Morphology;Particleanalysis--medical/surgicalapplications;Scanningelectronmicroscope(SEM);Weardebris;Weartesting--surgicalimplantmaterials/applications
【摘要】:Thebiologicalresponsetomaterialsintheformofsmallparticles,asfromweardebris,oftenissignificantlydifferentfromthattothesamematerialsaslargerimplantcomponents.Thesizeandshape(morphology)oftheparticlesmayhaveamajoreffectonthebiologicalresponse;therefore,thispracticeprovidesastandardizednomenclaturefordescribingparticles.Suchaunifiednomenclaturewillbeofvalueininterpretationofbiologicaltestsofresponsestoparticles,inthatitwillfacilitateseparationofbiologicalresponsesassociatedwithshapefromthoseassociatedwiththechemicalcompositionofdebris.Thequantity,size,andmorphologyofparticlesreleasedasweardebrisfromimplantsinvivomayproduceanadversebiologicalresponsewhichwillaffectthelongtermsurvivalofthedevice.Characterizationofsuchdebriswillprovidevaluableinformationregardingtheeffectivenessofdevicedesignsormethodsofprocessingcomponentsandthemechanismsofwear.Themorphologyofparticlesproducedinlaboratorytestsofwearandabrasionoftenisaffectedbythetestconditions,suchasthemagnitudeandrateofloadapplication,deviceconfiguration,andtestenvironment.Comparisonofthemorphologyandsizeofparticlesproducedinvitrowiththoseproducedinvivowillprovidevaluableinformationregardingthedegreetowhichthemethodsimulatestheinvivoconditionbeingmodeled.1.1Thispracticecoversaseriesofproceduresforcharacterizationofthemorphology,number,size,andsizedistributionofparticles.Themethodsutilizedincludesieves,optical,SEM,andelectrooptical.1.2Thesemethodsareappropriateforparticlesproducedbyanumberofdifferentmethods.Theseincludeweartestmachines(TestMethodF732),totaljointsimulationsystems(GuidesF1714andF1715),abrasiontesting,methodsforproducingparticulates,suchasshatterboxesorpulverizors,commerciallyavailableparticles,andparticlesharvestedfromtissuesinanimalorclinicalstudies.1.3Thedebrismayincludemetallic,polymeric,ceramic,oranycombinationofthese.1.4Thedigestionprocedurestobeusedandissuesofsterilizationofretrievedparticlesarenotthesubjectofthispractice.1.5AclassificationschemefordescriptionofparticlemorphologyisincludedinAppendixX3.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Asaprecautionarymeasure,removeddebrisfromimplanttissuesshouldbesterilizedorminimallydisinfectedbyanappropriatemeansthatdoesnotadverselyaffecttheparticulatematerial.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A42
【国际标准分类号】:19_120
【页数】:14P.;A4
【正文语种】:英语
【原文标准名称】:粒度特征标准实施规程
【标准号】:ASTMF1877-2005(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2005
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;morphology;particles;SEM;weardebris;Biocompatibility;Morphology;Particleanalysis--medical/surgicalapplications;Scanningelectronmicroscope(SEM);Weardebris;Weartesting--surgicalimplantmaterials/applications
【摘要】:Thebiologicalresponsetomaterialsintheformofsmallparticles,asfromweardebris,oftenissignificantlydifferentfromthattothesamematerialsaslargerimplantcomponents.Thesizeandshape(morphology)oftheparticlesmayhaveamajoreffectonthebiologicalresponse;therefore,thispracticeprovidesastandardizednomenclaturefordescribingparticles.Suchaunifiednomenclaturewillbeofvalueininterpretationofbiologicaltestsofresponsestoparticles,inthatitwillfacilitateseparationofbiologicalresponsesassociatedwithshapefromthoseassociatedwiththechemicalcompositionofdebris.Thequantity,size,andmorphologyofparticlesreleasedasweardebrisfromimplantsinvivomayproduceanadversebiologicalresponsewhichwillaffectthelongtermsurvivalofthedevice.Characterizationofsuchdebriswillprovidevaluableinformationregardingtheeffectivenessofdevicedesignsormethodsofprocessingcomponentsandthemechanismsofwear.Themorphologyofparticlesproducedinlaboratorytestsofwearandabrasionoftenisaffectedbythetestconditions,suchasthemagnitudeandrateofloadapplication,deviceconfiguration,andtestenvironment.Comparisonofthemorphologyandsizeofparticlesproducedinvitrowiththoseproducedinvivowillprovidevaluableinformationregardingthedegreetowhichthemethodsimulatestheinvivoconditionbeingmodeled.1.1Thispracticecoversaseriesofproceduresforcharacterizationofthemorphology,number,size,andsizedistributionofparticles.Themethodsutilizedincludesieves,optical,SEM,andelectrooptical.1.2Thesemethodsareappropriateforparticlesproducedbyanumberofdifferentmethods.Theseincludeweartestmachines(TestMethodF732),totaljointsimulationsystems(GuidesF1714andF1715),abrasiontesting,methodsforproducingparticulates,suchasshatterboxesorpulverizors,commerciallyavailableparticles,andparticlesharvestedfromtissuesinanimalorclinicalstudies.1.3Thedebrismayincludemetallic,polymeric,ceramic,oranycombinationofthese.1.4Thedigestionprocedurestobeusedandissuesofsterilizationofretrievedparticlesarenotthesubjectofthispractice.1.5AclassificationschemefordescriptionofparticlemorphologyisincludedinAppendixX3.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Asaprecautionarymeasure,removeddebrisfromimplanttissuesshouldbesterilizedorminimallydisinfectedbyanappropriatemeansthatdoesnotadverselyaffecttheparticulatematerial.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A42
【国际标准分类号】:19_120
【页数】:14P.;A4
【正文语种】:英语
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