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DB65/T 2873-2008 商业洗衣洗涤服务质量规范

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基本信息
标准名称:商业洗衣洗涤服务质量规范
发布日期:2008-01-01
实施日期:2008-04-20
首发日期:
作废日期:
主管部门:新疆维吾尔自治区质量技术监督局
出版社:中国标准出版社
出版日期:2008-04-20
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所属分类: 农业 林业 林业 木材竹材防腐 农业 农业和林业
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【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】:


MIL-T-5237E, MILITARY SPECIFICATION: TAPE, TEXTILE; WEBBING, TEXTILE; RAYON (04 SEP 1990)., This specification covers rayon tape and webbing