ISO 15223-2000 医疗器械用于医疗器械标签、作标记和提供信息的符号
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【英文标准名称】:Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labellingandinformationtobesupplied
【原文标准名称】:医疗器械用于医疗器械标签、作标记和提供信息的符号
【标准号】:ISO15223-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-04
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:产品;医疗设备;信息;图解表示法;医疗装置;加标签;医学科学;图形符号;保障;医疗技术学;医疗产品;作标记;规范(验收);医疗器械;符号
【英文主题词】:Graphicrepresentation;Graphicsymbols;Information;Labelling;Marking;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Medicaltechnology;Products;Provision;Specification(approval);Symbols
【摘要】:ThisInternationalStandardidentifiessymbolsconventionallyusedtoconveyinformationessentialforproperusetotheuserandothersforsafeandeffectiveuseofmedicaldevices.ThisInternationalStandardisprimarilyintendedtobeusedby:—manufacturersofmedicaldeviceswhomarkettheirproductsinanumberofcountrieshavingdifferentlanguagerequirementsformedicaldevicelabelling;—usersofmedicaldeviceswhodrawtheirsuppliesfromanumberofsourcesandmayhavevariedlanguagecapabilities;—thoseresponsibleforpostmarketsurveillance;—healthcareregulatoryauthorities,testingorganizations,certificationbodiesandotherorganizationsresponsibleforimplementingregulationsaffectingmedicaldevicesandhavingresponsibilityforpostmarketsurveillance.ThisInternationalStandardmayalsobeofassistanceto:—manufacturershavingtocopewithspacelimitationsonsmalllabels;—distributorsofmedicaldevicesorotherrepresentativesofmanufacturers;—healthcareauthoritiesresponsiblefortrainingaswellasthosebeingtrained.NOTEThisInternationalStandarddealswithasmallnumberofsymbolsthatmaybeusedwhenappropriateonthedeviceitself,itspackageorintheaccompanyingdocumentation.Manyotherstandards,suchasIEC60601-1,specifyadditionalsymbolsthatareapplicabletoparticularkindsorgroupsofdevices,ortoparticularsituations.
【中国标准分类号】:C04
【国际标准分类号】:01_080_20;11_040_01
【页数】:8P;A4
【正文语种】:英语
【原文标准名称】:医疗器械用于医疗器械标签、作标记和提供信息的符号
【标准号】:ISO15223-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-04
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:产品;医疗设备;信息;图解表示法;医疗装置;加标签;医学科学;图形符号;保障;医疗技术学;医疗产品;作标记;规范(验收);医疗器械;符号
【英文主题词】:Graphicrepresentation;Graphicsymbols;Information;Labelling;Marking;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Medicaltechnology;Products;Provision;Specification(approval);Symbols
【摘要】:ThisInternationalStandardidentifiessymbolsconventionallyusedtoconveyinformationessentialforproperusetotheuserandothersforsafeandeffectiveuseofmedicaldevices.ThisInternationalStandardisprimarilyintendedtobeusedby:—manufacturersofmedicaldeviceswhomarkettheirproductsinanumberofcountrieshavingdifferentlanguagerequirementsformedicaldevicelabelling;—usersofmedicaldeviceswhodrawtheirsuppliesfromanumberofsourcesandmayhavevariedlanguagecapabilities;—thoseresponsibleforpostmarketsurveillance;—healthcareregulatoryauthorities,testingorganizations,certificationbodiesandotherorganizationsresponsibleforimplementingregulationsaffectingmedicaldevicesandhavingresponsibilityforpostmarketsurveillance.ThisInternationalStandardmayalsobeofassistanceto:—manufacturershavingtocopewithspacelimitationsonsmalllabels;—distributorsofmedicaldevicesorotherrepresentativesofmanufacturers;—healthcareauthoritiesresponsiblefortrainingaswellasthosebeingtrained.NOTEThisInternationalStandarddealswithasmallnumberofsymbolsthatmaybeusedwhenappropriateonthedeviceitself,itspackageorintheaccompanyingdocumentation.Manyotherstandards,suchasIEC60601-1,specifyadditionalsymbolsthatareapplicabletoparticularkindsorgroupsofdevices,ortoparticularsituations.
【中国标准分类号】:C04
【国际标准分类号】:01_080_20;11_040_01
【页数】:8P;A4
【正文语种】:英语
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