| 标准号： |
ISO 80601-2-12-2011 |
| 英文名称： |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 中标分类： |
医药卫生劳动保护>>手术室设备 |
| 发布日期： |
2011-04-15 |
| 发布单位： |
IX-ISO |
| 标准状态： |
请与本站工作人员进行确认 |
| ICS分类： |
麻醉、呼吸和复苏设备>>麻醉、呼吸和复苏设备 |
| 起草单位/标准公告： |
ISO/TC 121 |
| 正文语言： |
英语 |
| 页数： |
88P.;A4 |
| 附注： |
This document is recommended by the issuing body of IEC 62D/879/FDIS (2010-11), IEC 62D/894/FDIS (2010-12), IEC 60601-2-12 (2001-10), IEC 60601-2-12 (2001-10) which was withdrawn without replacement. / Note: Applies in conjunction with IEC 60601-1 (2005-12). |
| 被代替标准： |
ISO/FDIS 80601-2-12-2010 |
| 引用标准： |
IEC 60601-1-2005;IEC 60601-1-2-2007;IEC 60601-1-6-2010;IEC 60601-1-8-2006;IEC 61672-1-2002;ISO 32-1977;ISO 594-1-1986;ISO 594-2-1998;ISO 3744-2010;ISO 4135-2001;ISO 4871-1996;ISO 5356-1-2004;ISO 5359-2008;ISO 5367-2000;ISO 7000-2004;ISO 7010;ISO 7010-2003;ISO 7396-1-2007;ISO 8185-2007;ISO 8836-2007;ISO 9360-1-2000;ISO 9360-2-2001;ISO 10079-1-1999;ISO 10079-3-1999;ISO 10524-1-2006;ISO 11195-1995;ISO 14937-2009;ISO 15223-1-2007;ISO 17664-2004;ISO 23328-1-2003;ISO 23328-2-2002;ISO 80601-2-13;ISO 80601-2-55;IEC 60068-2-27-2008;IEC 60068-2-31-2008;IEC 60068-2-64-2008;ISO 60529-1989;IEC 60601-1-11-2010;IEC 60601-2-2-2009;IEC 62304-2006;IEC 62366-2007 |
| 采用关系： |
DIN EN ISO 80601-2-12-2012,IDT;ABNT NBR ISO 80601-2-12-2014,IDT;BS EN ISO 80601-2-12-2011,IDT;EN ISO 80601-2-12-2011,IDT;NF S95-118-2011,IDT;S95-118PR,IDT;SN EN ISO 80601-2-12-2011,IDT;OEVE/OENORM EN ISO 80601-2-12-2012,IDT;PN-EN ISO 80601-2-12-2011,IDT;SS-EN ISO 80601-2-12-2011,IDT;UNE-EN ISO 80601-2-12-2011,IDT;GOST R ISO 80601-2-12-2013,IDT;DS/EN ISO 80601-2-12-2011,IDT;UNI EN ISO 80601-2-12-2011-2011,IDT;STN EN ISO 80601-2-12-2011,IDT;CSN EN ISO 80601-2-12-2011,IDT;DS/EN ISO 80601-2-12-2011,IDT;NEN-EN-ISO 80601-2-12-2011 en-2011,IDT |
| 内容提要（CN）： |
事故预防;调节;送风;报警;α辐射线;人工呼吸;组装;袋;β辐射;生物适应性;呼吸;呼吸装置;呼吸设备;充电;夹件;等级;清洁处理;兼容性;校正(误差);组件;连接;恒电流;控制仪器;转角;封盖物;排除污染;缺陷;定义(术语);设计;介电强度;放电;消毒;长距通信;接地导线;接地;接地线端子;边;电力系统;电击;电气事故;电气工程;医用电气设备;电气安全性;电磁学;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;设备安全性;故障;过滤器;防火;火灾危险;柔性管;γ辐射;搬运;热传导;湿润剂;液压装置;红外线辐射;输入电流;检验;使用说明书;仪器;强化护理设备;强化护理病房;中断;钻模;激光辐射;布置;泄漏量;清晰度;极限;液体;光辐射;肺通气机;标志;质量(物质);测量仪器;机械安全性;力学;医用呼吸器;医疗设备;医学科学;医疗技术学;微波炉辐射;潮气;中子射线;噪声;护理;职业安全性;操作;引出端;溢水口;氧;供氧;包装件;纸;装置部件;患者辅助电流;气动力学;电位均衡;功率消耗;动力传动系统;精密度;压力;压力释放;压力容器;保护(装置);防电击;保护覆盖层;保护装置;辐射防护;电阻器;呼吸作用;呼吸器;安全性;安全性工程;安全性要求;分离;信号;声能;规范(验收);稳定性;灭菌;材料强度;应力;物质;表面;系统接地;温度;拉力;试验;试验条件;超声波学;紫外线辐射;使用;振动;能见度;体积;警告;工作数据;工作场所安全性;X射线 |
| 内容提要（EN）： |
Accident prevention;Adjustments;Air supply;Alarm;Alpha radiation;Artificial respiration;Assembling;Bags;Beta radiation;Biocompatibility;Breathing;Breathing apparatus;Breathing equipment;Chargings;Clamps;Classes;Cleaning;Compatibility;Compensation (errors);Components;Connections;Continuous current;Control instruments;Corners;Covers;Decontaminations;Defects;Definitions;Design;Dielectric strength;Discharge;Disinfections;Distant transmission;Earth conductors;Earthing;Earthing conductor terminations;Edge;Electric power systems;Electric shock;Electrical accidents;Electrical engineering;Electrical medical equipment;Electrical safety;Electromagnetism;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmental conditions;Environmental testing;Equipment;Equipment safety;Failure;Filters;Fire prevention;Fire risks;Flexible pipes;Gamma-radiation;Handling;Heat exchange;Humectants;Hydraulics;Infrared radiation;Input current;Inspection;Instructions for use;Instruments;Intensive care equipment;Intensive-care ward;Interruptions;Jigs;Laser radiation;Layout;Leakage;Legibility;Limitations;Liquids;Luminous radiation;Lung ventilators;Marking;Mass;Measuring instruments;Mechanical safety;Mechanics;Medical breathing apparatus;Medical equipment;Medical sciences;Medical technology;Microwave radiation;Moisture;Neutron radiation;Noise;Nursing;Occupational safety;Operation;Outlets;Overflows;Oxygen;Oxygen supply;Packages;Paper;Part of a device;Patient auxiliary current;Pneumatics;Potential equalization;Power consumption;Power transmission systems;Precision;Pressure;Pressure releases;Pressure vessels;Protection;Protection against electric shocks;Protection coverings;Protective devices;Radiation protection;Resistors;Respiration;Respirators;Safety;Safety engineering;Safety requirements;Separation;Signals;Sound energy;Specification (approval);Stability;Sterilization (hygiene);Strength of materials;Stress;Substances;Surfaces;System earthing;Temperature;Tensile force;Testing;Testing conditions;Ultrasonics;Ultraviolet radiation;Use;Vibrations;Visibility;Volume;Warnings;Working data;Workplace safety;X-rays |
| 归属： |
国际 |
|
