BS EN ISO 9919-2009 医疗电气设备.医用脉冲血氧仪基本安全性和必要性能的详细要求

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                   【英文标准名称】:     Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)            【原文标准名称】:     医疗电气设备.医用脉冲血氧仪基本安全性和必要性能的详细要求            【标准号】:     BS EN ISO 9919-2009            【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】: 报警;α辐射;麻醉设备;组装;β辐射;生物适应性;血细胞计数;壳体;呼吸设备;充电;化学分析和测试;夹件;清洁处理;兼容性;元部件;连接件;恒电流;转角;封盖物;缺陷与故障;定义(术语);测定;介电强度;放电;消毒;接地导线;接地线端子;边;电力系统;电的;医用电气设备;电气安全性;电磁兼容性;电医学;静电学;电磁兼容性(EMC);外壳;能量;环境条件;环境测试;设备安全性;防火;γ辐射;血红蛋白;血红蛋白含量;液压装置;红外线辐射;输入电流;中断;激光束;布置;极限;液体;发光辐射;质量(物质);测量仪器;力学;医疗器械;医疗设备;医学科学;医疗技术学;潮气;中子射线;噪声;引出端;溢水口;光电血氧计;血样定量法;氧饱和;纸;患者辅助电流;性能要求;气动力学;电位均衡;功率消耗;精密度;压力;压力容器;防电击;保护覆盖层;保护装置;保护措施;脉冲;脉冲血氧计;辐射防护;安全性;安全工程;安全性要求;饱和;分离;信号;声能;规范(验收);稳定性;灭菌;材料强度;应力;表面;系统接地;温度;测试;超声波学;紫外线辐射;使用;振动;工作数据;X射线【英文主题词】: Alarm;Alpha radiation;Anaesthetic equipment;Assembling;Beta radiation;Biocompatibility;Blood counts;Bodies;Breathing equipment;Chargings;Chemical analysis and testing;Clamps;Cleaning;Compatibility;Components;Connections;Continuous current;Corners;Covers;Defects;Definitions;Determinations;Dielectric strength;Discharge;Disinfections;Earth conductors;Earthing conductor terminations;Edge;Electric power systems;Electrical;Electrical medical equipment;Electrical safety;Electromagnetic compatibility;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmental conditions;Environmental testing;Equipment safety;Fire prevention;Gamma-radiation;Haemoglobin;Haemoglobin content;Hydraulics;Infrared radiation;Input current;Interruptions;Laser beams;Layout;Limitations;Liquids;Luminous radiation;Mass;Measuring instruments;Mechanics;Medical devices;Medical equipment;Medical sciences;Medical technology;Moisture;Neutron radiation;Noise;Outlets;Overflows;Oximeters;Oximetry;Oxygen saturationaperatient auxiliary currenterformance requirementsneumaticsotential equalizationower consumptionrecisionressureressure vesselsrotection against electric shocks;Protection coverings;Protective devices;Protective measures;Pulse;Pulse oximeters;Radiation protection;Safety;Safety engineering;Safety requirements;Saturation;Separation;Signals;Sound energy;Specification (approval);Stability;Sterilization (hygiene);Strength of materials;Stress;Surfaces;System earthing;Temperature;Testing;Ultrasonics;Ultraviolet radiation;Use;Vibrations;Working data;X-rays【摘要】: IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment (add at the end of 1.1):This International Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender.These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulseoximeter probes and probe cable extenders, that has been reprocessed.The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care.* This International Standard is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient.This International Standard is not applicable to pulse oximeter equipment solely intended for foetal use.This International Standard is not applicable to remote or slave (secondary) devices that display SpO values that are located outside of the patient environment.The requirements of this International Standard which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.【中国标准分类号】: C39【国际标准分类号】: 11_040_10【页数】: 98P.;A4【正文语种】: 英语