ISO 9919-2005 医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求

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【英文标准名称】:Medicalelectricalequipment-Particularrequirementsforthebasicsafetyandessentialperformanceofpulseoximeterequipmentformedicaluse
【原文标准名称】:医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求
【标准号】:ISO9919-2005
【标准状态】:作废
【国别】:国际
【发布日期】:2005-03
【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/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗技术学;安全;设备安全;定义;安全工程;测量仪器;测定;电气安全;血红蛋白含量;血氧计;血氧测量;脉动式血氧计;医疗设备;呼吸设备;规范(验收);电磁兼容性;电医学;安全要求;麻醉设备;饱和;血红蛋白;氧饱和;防火;医学科学;辐射防护;化学分析和试验;医用电气设备;性能要求;脉冲;血细胞计数
【英文主题词】:Alarm;Assembling;Biocompatibility;Bloodcounts;Cables;Chargings;Chemicalanalysisandtesting;Clamps;Cleaning;Compatibility;Components;Connections;Continuouscurrent;Corners;Covers;Defects;Definitions;Design;Determinations;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Electricpowersystems;Electrical;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipmentsafety;Extensioncables;Fireprevention;Haemoglobin;Haemoglobincontent;Inputcurrent;Interruptions;Layout;Limitations;Liquids;Mass;Measuringinstruments;Mechanics;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Monitors;Noise;Overflows;Oximeters;Oximetry;Oxygensaturation;Patientauxiliarycurrent;Performancerequirements;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Protectivemeasures;Pulse;Pulseoximeters;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Saturation;Sensors;Signals;Soundenergy;Specification(approval);Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Systemearthing;Temperature;Testing;Ultrasonics;Use;Vibrations;Workingdata
【摘要】:IEC60601-1:1988,Clause1applies,exceptasfollows.Amendment(addattheendof1.1):ThisInternationalStandardspecifiesparticularrequirementsforthebasicsafetyandessentialperformanceofpulseoximeterequipmentintendedforuseonhumans.Thisincludesanypartnecessaryfornormaluse,e.g.thepulseoximetermonitor,pulseoximeterprobe,probecableextender.Theserequirementsalsoapplytopulseoximeterequipment,includingpulseoximetermonitors,pulseoximeterprobesandprobecableextenders,thathasbeenreprocessed.Theintendeduseofpulseoximeterequipmentincludes,butisnotlimitedto,theestimationofarterialoxygenhaemoglobinsaturationandpulserateonpatientsinhealthcareinstitutionsaswellasonpatientsinhomecare.*ThisInternationalStandardisnotapplicabletopulseoximeterequipmentintendedforuseinlaboratoryresearchapplicationsnortooximetersthatrequiresabloodsamplefromthepatient.ThisInternationalStandardisnotapplicabletopulseoximeterequipmentsolelyintendedforfoetaluse.ThisInternationalStandardisnotapplicabletoremoteorslave(secondary)devicesthatdisplaySpO2valuesthatarelocatedoutsideofthepatientenvironment.TherequirementsofthisInternationalStandardwhichreplaceormodifyrequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.
【中国标准分类号】:C44
【国际标准分类号】:11_040_55
【页数】:81P;A4
【正文语种】:英语