【英文标准名称】:StandardPracticeforEvaluationofDelayedContactHypersensitivityUsingtheMurineLocalLymphNodeAssay(LLNA)
【原文标准名称】:使用鼠科动物局部淋巴结化验(LLNA)评估迟发性接触超敏反应的标准实施规程
【标准号】:ASTMF2148-2007e1
【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】:敏感症;动物;评估;实验动物;微生物分析;毒物学的试验
【英文主题词】:biocompatibility;contacthypersensitivity;locallymphnodeassay;LLNA;mouse;sensitization
【摘要】:Thepropensityofamaterialtostimulatedelayedcontacthypersensitivitymustbeassessedbeforeclinicalapplicationofdevicescontainingthismaterial.Delayedhypersensitivitymayoccuranywhereinthebody.Systemicdelayedhypersensitivitymayhaveacomplexsetofreactionsandconsequencesdependingontheactualtissue/organsiteofreaction.Althoughthereactionsareseldomlife-threatening,severetissueandorgandamagemyresultovertime.Skinistheusualtestsitetodeterminethepropensityofamaterialtocausedelayedhypersensitivity.Thestandardhistoricaltestmethodshaveinvolvedtheuseofguineapigswithacutaneousapplicationandobservationofthereactionsite.Theuseofthemurinelocallymphnodeassayresultsinanumericalquantitationofstimulation,ratherthansubjectiveevaluationandcouldbeusedtodeterminedoseresponses.Thispracticemaynotbepredictiveofeventsoccurringduringalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.1.1Thispracticeprovidesamethodologytouseanin-situprocedurefortheevaluationofdelayedcontacthypersensitivityreactions.1.2Thispracticeisintendedtoprovideanalternativetotheuseofguineapigsforevaluationoftheabilityofadevicematerialtostimulatedelayedcontacthypersensitivityreactions.Thisalternativeisparticularlyapplicableformaterialsusedindevicesthatcontactonlyintactskin.However,theguineapigmaximizationtestisstilltherecommendedmethodwhenassessingthedelayedhypersensitivityresponsetometalsorwhentestingsubstancesthatdonotpenetratetheskinbutareusedindevicesthatcontactdeeptissuesorbreachedsurfaces.Theguineapigmaximizationtestshouldbeusedforthesesubstances.1.3Thispracticeconsistsofaprotocolforassessinganincreaseinlymphocyteproliferationwithinthenodesdrainingthesiteofadministrationontheearsofmice.1.4TheLLNAhasbeenvalidatedonlyforlowmolecularweightchemicalsthatcanpenetratetheskin.Theabsorbedchemicalormetabolitemustbindtomacromolecules,suchasproteins,toformimmunogenicconjugates.1.5Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.6Identificationofasupplierofmaterialsorreagentsisfortheconvenienceoftheuseranddoesnotimplysinglesource.Appropriatematerialsandreagentsmaybeobtainedfrommanycommercialsupplyhouses.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A40;C04
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】: