ASTM F720-1981(2007)e1 接触过敏原用试验天竺鼠的标准实施规程:天竺鼠最大化敏感试验

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【英文标准名称】:StandardPracticeforTestingGuineaPigsforContactAllergens:GuineaPigMaximizationTest
【原文标准名称】:接触过敏原用试验天竺鼠的标准实施规程:天竺鼠最大化敏感试验
【标准号】:ASTMF720-1981(2007)e1
【标准状态】:现行
【国别】:
【发布日期】:1981
【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】:过敏性反应;医学科学;猪;试验
【英文主题词】:acutetoxicitytests;allergenicity;biocompatibility;guineapigs;sensitization;testanimals
【摘要】:Inselectinganewmaterialforhumancontactinmedicalapplications,itisimportanttoensurethatthematerialwillnotstimulatetheimmunesystemtoproduceanallergicreaction.Thereactionwouldbeduetosubstanceswhichcouldleachoutofamaterial.Therefore,thispracticeprovidesforusingmaterialextracts.Therationaleforthispracticeisbasedonthefactthattheguineapighasbeenshowntobethebestanimalmodelforhumanallergiccontactdermatitis.TheuseofFreundrsquo;completeadjuvantandsodiumlaurylsulfatetendstoenhancethepotentialofamaterialtocauseanallergy.Therefore,thistest,whilenotguaranteeingthatamaterialisnonallergenic,isthemostsevereanimaltestincommonusetoday.1.1Thispracticeisintendedtodeterminethepotentialforasubstance,ormaterialextract,toelicitcontactdermalallergenicity.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:B41
【国际标准分类号】:11_220
【页数】:3P.;A4
【正文语种】: