ASTM F895-1984(2006) 琼脂扩散细胞培养屏蔽细胞毒素的试验方法

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【英文标准名称】:StandardTestMethodforAgarDiffusionCellCultureScreeningforCytotoxicity
【原文标准名称】:琼脂扩散细胞培养屏蔽细胞毒素的试验方法
【标准号】:ASTMF895-1984(2006)
【标准状态】:现行
【国别】:
【发布日期】:1984
【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】:(TestMethod)
【标准水平】:()
【中文主题词】:屏蔽;医学科学;试验;琼脂扩散试验;毒性;医疗设备
【英文主题词】:agardiffusion;biocompatibility;cellculture;cytotoxicitytesting
【摘要】:Thistestmethodisusefulforassessingthecytotoxicpotentialofnewmaterialsandformulationsandaspartofaqualitycontrolprogramforestablishedmedicaldevicesandcomponents.Thistestmethodassumesthatassessmentofcytotoxicityprovidesusefulinformationtoaidinpredictingthepotentialclinicalapplicationsinhumans.Cellculturemethodshaveshowngoodcorrelationwithanimalassaysandarefrequentlymoresensitivetocytotoxicagents.Thiscellculturetestmethodissuitableforincorporationintospecificationsandstandardsformaterialstobeusedintheconstructionofmedicaldevicesthataretobeimplantedintothehumanbodyorplacedincontactwithtissuefluidsorbloodonalong-termbasis.Somebiomaterialswithahistoryofsafeclinicaluseinmedicaldevicesarecytotoxic.Thistestmethoddoesnotimplythatallbiomaterialsmustpassthisassaytobeconsideredsafeforclinicaluse(PracticeF748).1.1Thistestmethodisappropriateformaterialsinavarietyofshapesandformaterialswhicharenotnecessarilysterile.Thistestmethodwouldbeappropriateinsituationswheretheamountofmaterialislimited.Forexample,smalldevicesorpowderscouldbeplacedontheagarandthepresenceofazoneofinhibitionofcellgrowthcouldbeexamined.1.1.1Thistestmethodisnotappropriateforleachableswhichdonotdiffusethroughagaroragarose.1.1.2Whiletheagarlayercanactasacushiontoprotectthecellsfromthespecimen,theremaybematerialswhicharesufficientlyheavytocompresstheagarandpreventdiffusionortocausemechanicaldamagetothecells.Thistestmethodwouldnotbeappropriateforthesematerials.1.2TheL-929celllinewaschosenbecauseithasasignificanthistoryofuseinassaysofthistype.Thisisnotintendedtoimplythatitsuseispreferred,onlythattheL-929isanestablishedcellline,well-characterizedandreadilyavailable,thathasdemonstratedreproducibleresultsinseverallaboratories.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:07_100_10
【页数】:5P.;A4
【正文语种】: