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【英文标准名称】:StandardPracticetoEnhanceIdentificationofDrugNamesonLabels
【原文标准名称】:增强标签上药物名称的识别的标准实施规程
【标准号】:ASTMD6398-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:D10.32
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:colorcontrasts;labeling;labels;legibility;Drugcontainers/labels;Identification;Names(ofdrugs)
【摘要】:Medicationerrorsoccurwhenusersareconfusedbythesimilarsize,shape,color,typeface,andlayoutoflabelsthatareusedforarangeofamanufacturer''sdrugswithwidelydissimilaractionsorpotencies.Thehumanvisualsystemusesshape,size,color,andtypefaceintheinitialrecognitionofalabeleddrug.(See9.1-9.3.)Theuseofthishumanvisualsystemhasbeendescribedin21CFR429.12forthelabelingofinsulin.Usingthesimilarlabeldesign,color,andtypefacethroughoutaproductlinemakesidentifyinganindividualdrugmoredifficult.Theobjectiveofthispracticeistoprovideguidanceforthedesignofdruglabelswhichwillenableuserstoeasilydistinguishbetweendrugsofdifferingactionorpotency.SeeNote1.Note18212;ForspecificrequirementsfortheselabelsandotherfeaturesoflabelsforOTChumandrugs,see21CFR201.66.1.1Thispracticecoverstheshape,size,color,layout,typeface,andbarcodingondrugcontainerlabelsintendedforprescriptionproductpackagingsuchasmightbeusedinhospitals,pharmacies,andnursingcenters.1.1.1Thispracticedoesnotapplytobulkproductshippingcontainers;in-processtransfercontainers;orprimary,secondary,ortertiaryfinishedgoodscontainers.1.2Thispracticedoesnotapplytoover-the-counterdrugproductlabeling.1.3Thispracticedoesnotapplytoretailproductlabeling.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.
【中国标准分类号】:C08
【国际标准分类号】:35_040
【页数】:3P.;A4
【正文语种】:英语