ASTM F813-2007 直接接触细胞培养评估医疗器械材料的标准实施规程

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【英文标准名称】:StandardPracticeforDirectContactCellCultureEvaluationofMaterialsforMedicalDevices
【原文标准名称】:直接接触细胞培养评估医疗器械材料的标准实施规程
【标准号】:ASTMF813-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:细胞;评定;材料;医疗设备;医学科学;微生物学
【英文主题词】:biocompatibility;cellculture;cytotoxicitytesting;directcontactcytotoxicity
【摘要】:Thispracticeisusefulforassessingcytotoxicpotentialbothwhenevaluatingnewmaterialsorformulationsforpossibleuseinmedicalapplications,andaspartofaqualitycontrolprogramforestablishedmedicalmaterialsandmedicaldevices.Thispracticeassumesthatassessmentofcytotoxicitypotentialprovidesonemethodforpredictingthepotentialforcytotoxicornecroticreactionstomedicalmaterialsanddevicesduringclinicalapplicationstohumans.Ingeneral,cellculturetestingmethodshaveshowngoodcorrelationwithanimalassaysandarefrequentlymoresensitivetotoxicmoieties.Thiscellculturetestmethodissuitableforadoptioninspecificationsandstandardsformaterialsforuseintheconstructionofmedicaldevicesthatareintendedtobeimplantedinthehumanbodyorplacedincontactwithtissue,tissuefluids,orbloodonalong-termbasis.However,careshouldbetakenwhentestingmaterialsthatareresorbabletobesurethemethodisapplicable.Sincecellsinthisdirectcontacttestmethodarenotprotectedbyanoverlyingagaroselayer,theyaremoresusceptibletopotentialmechanicaldamageimpartedbytheoverlyingtestsample.Investigatorswishingtoevaluatethecytotoxicresponseofcellsunderlyingthetestsampleshouldconsideragarose-basedmethodssimilartoTestMethodF895.Alternatively,dependentonsamplecharacteristics,extractionmethodssuchasPracticeF619mayalsobeconsidered.1.1Thispracticecoversareferencemethodofdirectcontactcellculturetestingwhichmaybeusedinevaluatingthecytotoxicpotentialofmaterialsforuseintheconstructionofmedicalmaterialsanddevices.1.2Thispracticemaybeusedeitherdirectlytoevaluatematerialsorasareferenceagainstwhichothercytotoxicitytestmethodsmaybecompared.1.3Thisisoneofaseriesofreferencetestmethodsfortheassessmentofcytotoxicpotential,employingdifferenttechniques.1.4Assessmentofcytotoxicityisoneofseveraltestsemployedindeterminingthebiologicalresponsetoamaterial,asrecommendedinPracticeF748.1.5TheL-929celllinewaschosenbecauseithasasignificanthistoryofuseinassaysofthistype.Thisisnotintendedtoimplythatitsuseispreferred;onlythattheL-929isawell-characterized,readilyavailable,establishedcelllinethathasdemonstratedreproducibleresultsinseverallaboratories.1.6Sincethetestsampleisnotremovedatthetimeofmicroscopicevaluationandunderlyingcellsmaybeaffectedbythespecificgravityofthetestsample,thispracticeislimitedtoevaluationofcellsoutsidetheperimeteroftheoverlyingtestsample.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:07_100_10
【页数】:4P.;A4
【正文语种】: