BS EN ISO 18778-2009 呼吸设备.婴儿监视器.详细要求(ISO18778-2005)
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【英文标准名称】:Respiratoryequipment-Infantmonitors-Particularrequirements(ISO18778:2005)
【原文标准名称】:呼吸设备.婴儿监视器.详细要求(ISO18778-2005)
【标准号】:BSENISO18778-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;呼吸设备;儿童;防护等级;分类;分类系统;控制仪器;生命危险;定义(术语);设计;测定;尺寸规格;接地导线;电气器具;电接触保护;电气设备;医用电气设备;电气保护设备;电气安全性;电磁兼容性;电医学;环境条件;设备;设备安全性;特点;防火;防火安全性;医院设备;批注;检验;救生设备;作标记;测量;机械安全性;医疗器械;医疗设备;医学科学;医疗技术学;监视装置;职业安全;防电击;救护服务;安全性;安全装置;安全性工程;安全规则;安全性要求;规范(验收);监督(认可);试验环境;试验设备;测试;测试条件
【英文主题词】:Accidentprevention;Breathingequipment;Children;Classesofprotection;Classification;Classificationsystems;Controlinstruments;Dangertolife;Definitions;Design;Determinations;Dimensions;Earthconductors;Electricappliances;Electriccontactprotection;Electricalequipment;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Environmentalconditions;Equipment;Equipmentsafety;Features;Fireprevention;Firesafety;Hospitalequipment;Inscription;Inspection;Life-savingequipment;Marking;Measurement;Mechanicalsafety;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Monitoringdevice;Occupationalsafety;Protectionagainstelectricshocks;Rescueandambulanceservices;Safety;Safetydevices;Safetyengineering;Safetyregulations;Safetyrequirements;Specification(approval);Surveillance(approval);Testatmospheres;Testequipment;Testing;Testingconditions
【摘要】:IEC60601-1:1988,Clause1,appliesexceptasfollows:Amendments(addatendof1.1):1.1ThisInternationalStandardspecifiesrequirementsforthesafetyandessentialperformanceofmonitorsusedtodetectapparentlife-threateningevents1)insleepingorrestingchildrenunderthreeyearsofage.ThisInternationalStandardappliestodevicesusedinhomecareapplications.Thesemonitorsaregenerallyusedwithoutcontinualprofessionalsupervision.ThisInternationalStandardalsoappliestotheaccessories,e.g.probesandcablesnecessarytoapplythemonitortothepatient.ThisInternationalStandarddoesnotapplytomonitorsintendedforuseinhealthcarefacilities/institutions.TherequirementsofthisInternationalStandard,whichreplaceormodifytherequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995),areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.1.4Addition:NOTEPlanninganddesignofproductscomplyingwiththisStandardcanhaveenvironmentalimpactduringtheproductlifecycle.EnvironmentalaspectsareaddressedinAnnexBB.AdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:38P.;A4
【正文语种】:英语
【原文标准名称】:呼吸设备.婴儿监视器.详细要求(ISO18778-2005)
【标准号】:BSENISO18778-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;呼吸设备;儿童;防护等级;分类;分类系统;控制仪器;生命危险;定义(术语);设计;测定;尺寸规格;接地导线;电气器具;电接触保护;电气设备;医用电气设备;电气保护设备;电气安全性;电磁兼容性;电医学;环境条件;设备;设备安全性;特点;防火;防火安全性;医院设备;批注;检验;救生设备;作标记;测量;机械安全性;医疗器械;医疗设备;医学科学;医疗技术学;监视装置;职业安全;防电击;救护服务;安全性;安全装置;安全性工程;安全规则;安全性要求;规范(验收);监督(认可);试验环境;试验设备;测试;测试条件
【英文主题词】:Accidentprevention;Breathingequipment;Children;Classesofprotection;Classification;Classificationsystems;Controlinstruments;Dangertolife;Definitions;Design;Determinations;Dimensions;Earthconductors;Electricappliances;Electriccontactprotection;Electricalequipment;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Environmentalconditions;Equipment;Equipmentsafety;Features;Fireprevention;Firesafety;Hospitalequipment;Inscription;Inspection;Life-savingequipment;Marking;Measurement;Mechanicalsafety;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Monitoringdevice;Occupationalsafety;Protectionagainstelectricshocks;Rescueandambulanceservices;Safety;Safetydevices;Safetyengineering;Safetyregulations;Safetyrequirements;Specification(approval);Surveillance(approval);Testatmospheres;Testequipment;Testing;Testingconditions
【摘要】:IEC60601-1:1988,Clause1,appliesexceptasfollows:Amendments(addatendof1.1):1.1ThisInternationalStandardspecifiesrequirementsforthesafetyandessentialperformanceofmonitorsusedtodetectapparentlife-threateningevents1)insleepingorrestingchildrenunderthreeyearsofage.ThisInternationalStandardappliestodevicesusedinhomecareapplications.Thesemonitorsaregenerallyusedwithoutcontinualprofessionalsupervision.ThisInternationalStandardalsoappliestotheaccessories,e.g.probesandcablesnecessarytoapplythemonitortothepatient.ThisInternationalStandarddoesnotapplytomonitorsintendedforuseinhealthcarefacilities/institutions.TherequirementsofthisInternationalStandard,whichreplaceormodifytherequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995),areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.1.4Addition:NOTEPlanninganddesignofproductscomplyingwiththisStandardcanhaveenvironmentalimpactduringtheproductlifecycle.EnvironmentalaspectsareaddressedinAnnexBB.AdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:38P.;A4
【正文语种】:英语
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