【英文标准名称】:Plasticscollapsiblecontainersforhumanbloodandbloodcomponents-Part2:Graphicalsymbolsforuseonlabelsandinstructionleaflets
【原文标准名称】:人类血液及血液成分用塑料可折叠容器.第2部分:用于标签和说明手册上的图形符号
【标准号】:ISO3826-2-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC76
【标准类型】:()
【标准水平】:()
【中文主题词】:附录手册;血液;输血;组件;血液容器;定义;图形符号;加标签;标签;作标记;医疗设备;医疗产品;医学科学;医疗技术学;包装件;塑料袋;塑料容器;符号
【英文主题词】:Accompanyingleaflets;Blood;Bloodtransfusions;Components;Containersforblood;Definitions;Graphicsymbols;Labelling;Labels;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Plasticbags;Plasticcontainers;Symbols
【摘要】:ThispartofISO3826addressessymbolsthatmaybeusedtoconveycertainitemsofinformationrelatedtomedicaldevicesdedicatedtobloodcollectionprocessesandstorage.Theinformationmayberequiredonthedeviceitself,aspartofthelabel,orprovidedwiththedevice.Manycountriesrequirethattheirownlanguagebeusedtodisplaytextualinformationwithmedicaldevices.Thisraisesproblemstodevicemanufacturersandusers.ThesymbolsspecifiedinthispartofISO3826donotreplacecurrentnationalregulatoryrequirements.Manufacturersseektotakecostsoutoflabellingbyreducingorrationalizingvariants.Thisresultsinamajorproblemoftranslation,designandlogisticswhenmultiplelanguagesareincludedonasinglelabelorpieceofdocumentation.Asothermedicaldevices,bloodmedicaldevices,labelledinanumberofdifferentlanguages,canexperienceconfusionanddelayinlocatingtheappropriatelanguage.ThispartofISO3826proposessolutionstotheseproblemsthroughtheuseofinternationallyrecognizedsymbolswithpreciselydefinedmeanings.ThispartofISO3826isprimarilyintendedtobeusedbymanufacturersofmedicaldevicesdedicatedtothebloodcollection,processstorageanddistribution,whomarketidenticalproductsincountrieshavingdifferentlanguagerequirementsformedicaldevicelabelling.ThispartofISO3826mayalsobeofassistancetodifferentstagesofthebloodsupplychain,e.g.:--distributorsofbloodcollectiondevices(manualorautomated)orotherrepresentativesofmanufacturers;--bloodcentresanddistributioncentrestosimplifyandsecuretheoperatingprocedures.Theuseofthesesymbolsisprimarilyintendedforthemedicaldeviceratherthanthetherapeuticproduct.ThispartofISO3826doesnotspecifyrequirementsrelatingtothesizeandcolourofsymbolsalthoughthesymbolsspecifiedhavebeenspeciallydesignedsoastobeclearlylegiblewhenreproducedinthespacetypicallyavailableonthelabelsofbloodtreatmentandtransfusiondevices,andalsosoastobesuitableforon-lineprinting.SeveralofthesymbolsspecifiedinthispartofISO3826maybesuitableforapplicationinotherareasofmedicaltechnology.
【中国标准分类号】:C44
【国际标准分类号】:01_080_20;11_040_20
【页数】:11P;A4
【正文语种】:英语