ASTM D6355-2007 医用手套使人体再现过敏斑点的测试用标准试验方法

作者:标准资料网 时间:2024-05-12 07:25:14  浏览:8276   来源:标准资料网

【英文标准名称】:StandardTestMethodforHumanRepeatInsultPatchTestingofMedicalGloves
【原文标准名称】:医用手套使人体再现过敏斑点的测试用标准试验方法
【标准号】:ASTMD6355-2007
【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】:D11.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:过敏性反应;手套;天然橡胶胶乳;橡胶;致敏性;合成橡胶;测试
【英文主题词】:ACD;allergiccontactdermatitis;allergy;dermatitis;Draize;glove;latex;naturalrubberlatex;repeatinsultpatchtest;RIPT;rubber;sensitization;syntheticrubber
【摘要】:1.1ThistestmethodisdesignedtoevaluatethepotentialofglovematerialsundertesttoinduceandelicitTypeIVskinsensitizationreactions(thatis,allergiccontactdermatitis)inhumans.1.2Thistestmethodshouldbeusedbyindividualsexperiencedinorunderthesupervisionofthoseexperiencedintheuseofgoodclinicalpracticeprocedures.1.3DuringtheperformanceoftheHumanRepeatInsultPatchTest(RIPT)fordeterminingsensitization,investigatorsareconfrontedwithskinresponsesthatrepresentskinirritation(non-immunologicresponses)orallergiccontactdermatitis(ACD).Thenumericalscoringsystemforgradingtheintensityofbotharesimilarandtestfacilitiesmayvaryintheirscoresthatdescribeintensitiesofallergicandirritantskinresponses.Thehallmarkofamildallergiccontactdermatitisisasustainedpalpableerythematousreaction.Delayed-typeallergiccontactreactionsfrompatchtestshaveintensitycharacteristicsthatfavorscoresofhighervaluesforlongerperiodsoftimeandtypicallydonotproduceaminimalscore(scoreof1,ajust-perceptibleerythema)forshortdurations(lessthan48h).Itistheresponsibilityoftheinvestigatortoevaluatethescoresinlightofirritantreactionssothattheresponsesareallergicinnatureandnotirritant.Theinvestigatorshoulddenoteafinalscoreaseitherduetocontactallergyorirritation.Paragraphs9.5-9.5.5describeacommonlyusedscoringsystemanddiscussallergicandirritantresponsesindetail.1.4TheDraizeRIPTwaspublishedin1944asanattempttodecreasethefrequencyACD.Thetesttechniquesatthattimewerejustbeingvalidatedandthisexperimentaldesignwaslargelyempiric.Theprincipleofthetestisasfollows:1.4.1Multipleinductionsofthestudymaterialatrelativelynonorlowirritancylevels,1.4.2Approximatelyatwo-weekrestperiod,and1.4.3Astandarddiagnosticchallengeofapproximately48handadelayedreadingatapproximately96hafterpatchapplication.1.5Intheinterveningyears,withfurtherexperimentationaddedtothisempiricapproach,threeadditionalprincipleshavebeenlearned:1.5.1Increasingtheconcentrationofthestudymaterial,1.5.2Defininganoeffectlevel(thisispossiblewithonlyindividualingredientsandnotthefinalstudymaterial),and1.5.3Theenhancedsensitivityandtheuseofocclusion(whereocclusionwouldnotordinarilybepresent).1.6In1945,HendersonandRileydemonstratedthatatestpanelsamplesizeof30000subjectswouldhavetobeemployedtoensurestatisticallythattherewouldbenomorethan0.1%sensitization.Iftherearenoallergicresponsesinatestpanelof200subjectswithexposurescomparabletothoseofthepopulation,thentherecouldbeasmanyas1.5allergicreactionsper100users.1.7Allmedicaldevicesmustbesafeandeffectivefortheirintendeduse.Sincemedicaldevicessuchasglovescomeincontactwithhumantissue,theyshouldbetestedforbiocompatibilityinanimalsfirst.Thehumanrepeatinsultpatchtest(RIPT)isonetestthatcanbeusedtotestrubberglovesforskinsensitizationtochemicalsusedinthemanufactureofgloves.1.7.1SincevariousformsoftheRIPTexist,asinglestandardizedtestmethodthatoutlinesthetestingprotocol,scoringsystem,andthecriteriaforskinsensitizationshouldbedeveloped.1.8Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C48
【国际标准分类号】:11_140
【页数】:7P.;A4
【正文语种】: