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【英文标准名称】:StandardPracticeforSubcutaneousScreeningTestforImplantMaterials
【原文标准名称】:植入材料的皮下筛选试验的标准实施规程
【标准号】:ASTMF1408-1997(2008)
【标准状态】:现行
【国别】:美国
【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(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;mice;orthopaedicmedicaldevices;short-termtissuescreening;subcutaneoustissuescreening;tissuecompatibility;toxicity/toxicology;Biocompatibility;Mice;Shorttermscreening;Subcutaneoustissuescreening;Testingmethods--
【摘要】:Thispracticeisaguidelineforashort-termscreeningtestfortheevaluationofthetissueresponsetomaterialsthatmaybeselectedforimplantationinthehumanbody.Thistestmaybeperformedpriortolongtermtesting(forexample,PracticeF981)toeliminateunsuitablecandidatematerialsearlyandtosavefurtheranimaltesting.Thispracticemaybeusedtodetecttoxiceffectsofmaterialsingeneral(seeAppendixX1).However,itisparticularlysuitableforthetestingofmaterialsthatareintendedtohavecontactwithsubcutaneoustissuesorsofttissuesingeneral.Formaterialsintendedtobeinsertedspecificallyintomuscletissues,PracticeF763shouldbeconsideredasashorttermtestmethod.Thesuggestedimplantspecimensarecylindrical.Aspecialgroovedtypeofcylindermaybeused(seeFig.X2.1ofAppendixX2)toallowtissueinterlockingthatcouldkeeptheimplantinplaceandminimizetissueirritationthroughmotionattheinterfacethatotherwisecouldcontributetoincreasedvarianceoftheresults.Incaseungroovedcylindersareused(seeFig.X1.2ofAppendixX2),probablemotionattheimplant/tissueinterfacemustbetakenintoaccount.Controlcylindersshouldbeshapedlikethetestcylinders.Thetypeofsurfacepreparationofthespecimenscanaffectthetissuereaction,thereforethepreparationprocedureshouldbenotedinthereport.Thetestmaybeusedtocomparetheeffectofdifferentsurfacestructuresorconditionsofthesamematerialortoassesstheeffectofvarioustreatmentsofmodificationsofamaterial.1.1Thispracticecoversashort-termtestingmethodtoscreenthesubcutaneoustissuereactiontometallicorotherimplantcandidatematerialsinsmalllaboratoryanimals.Thematerialmaybedenseorporous.Thetissuereactionswillbeevaluatedincomparisontothoseevokedbycontrolmaterialsthatareacceptedasclinicalimplantmaterials.1.2Thispractice,alongwithotherappropriatebiologicaltests(includingotherASTMtestmethods),maybeusedtoassessthebiocompatibilityofcandidatematerialsforuseinthefabricationofdevicesforclinicalapplication.Itmaybealsoappliedtoevaluatetheeffectofspecialsurfacetexturesandpreparationsofknownmaterials.1.3Thisexperimentalprotocolisnotdesignedtoprovideacomprehensiveassessmentofthesystemictoxicity,carcinogenicity,teratogenicity,ormutagenicityofthematerial.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语