BS EN ISO 8359-2009 医用氧气浓缩器.安全性要求(ISO 8359-1996)

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                   【英文标准名称】:     Oxygen concentrators for medical use - Safety requirements(ISO 8359:1996)            【原文标准名称】:     医用氧气浓缩器.安全性要求(ISO 8359-1996)            【标准号】:     BS EN ISO 8359-2009            【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;α辐射;组装;β辐射;生物适应性;壳体;呼吸装置;呼吸设备;充电;夹件;分类;清洁处理;色码;组件;浓缩器;连接;恒电流;转角;封盖物;缺陷与故障;定义(术语);介电强度;消毒;接地导线;接地线端子;边;电力系统;电击;电气安全性;电磁兼容性;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;爆炸危险;防爆;失效;防火;消防;火险;防火安全性;γ辐射;气体;格栅;高温防护;液压装置;指示;红外线辐射;内部的空气;输入电流;批注;检验;使用说明书;仪器;中断;激光束;布置;液体;光辐射;作标记;质量(物质);机械安全性;医用呼吸器;医疗器械;医疗设备;医用气体;医学科学;医疗技术学;药用植物;微波炉辐射;潮气;噪声;职业安全;操作说明书;引出端;溢水口;氧;供氧设备;氧浓度;纸;患者辅助电流;气动力学;电位均衡;功率消耗;精密度;压力;压力容器;保护(装置);危险防护;保护覆盖层;保护装置;辐射防护;安全性;安全工程;安全性要求;分离;声音;声能;规格;规范(验收);规范;稳定性;灭菌;材料强度;应力;供应;表面;系统接地;技术数据单;温度;试验组织;测试;热防护;超声波学;紫外线辐射;使用;振动;工作数据【英文主题词】: Accident prevention;Alpha radiation;Assembling;Beta radiation;Biocompatibility;Bodies;Breathing apparatus;Breathing equipment;Chargings;Clamps;Classification;Cleaning;Colour codes;Components;Concentrators;Connections;Continuous current;Corners;Covers;Defects;Definitions;Dielectric strength;Disinfections;Earth conductors;Earthing conductor terminations;Edge;Electric power systems;Electric shock;Electrical safety;Electromagnetic compatibility;Electrostatics;EMC;Enclosures;Energy;Environmental conditions;Environmental testing;Equipment safety;Explosion hazard;Explosion protection;Failure;Fire prevention;Fire protection;Fire risks;Fire safety;Gamma-radiation;Gases;Grids;Heat protection;Hydraulics;Indications;Infrared radiation;Inner atmosphere;Input current;Inscription;Inspection;Instructions for use;Instruments;Interruptions;Laser beams;Layout;Liquids;Luminous radiation;Marking;Mass;Mechanical safety;Medical breathing apparatus;Medical devices;Medical equipment;Medical gases;Medical sciences;Medical technology;Medicinal plants;Microwave radiation;Moisture;Noise;Occupational safety;Operational instructions;Outlets;Overflows;Oxygen;Oxygen breathing apparatus;Oxygen concentrationaperatient auxiliary currentneumaticsotential equalizationower consumptionrecisionressureressure vesselsrotectionrotection against danger;Protection coverings;Protective devices;Radiation protection;Safety;Safety engineering;Safety requirements;Separation;Sound;Sound energy;Specification;Specification (approval);Specifications;Stability;Sterilization (hygiene);Strength of materials;Stress;Supply;Surfaces;System earthing;Technical data sheets;Temperature;Test set-ups;Testing;Thermal protection;Ultrasonics;Ultraviolet radiation;Use;Vibrations;Working data【摘要】: NOTE 1 See the rationale in annex P.IS0 8359 is one of a series of International Standards based on IEC 601-1. In IEC 601-1 (the “General Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.The scope and object given in clause 1 of IEC 601-1 :1988 apply, except that 1.1 shall be replaced by the following:This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators intendedto supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing absorbers (see Introduction), as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.【中国标准分类号】: C46【国际标准分类号】: 11_040_10【页数】: 38P.;A4【正文语种】: 英语