医疗器械产品

测试标准

所有的医用电气设备
All the medical electrical equipment

IEC/EN 60601-1 2nd Ed & IEC/EN60601-1 3rd Ed

体外诊断设备In vitro diagnostic
(IVD) equipment

IEC/EN61010-1，IEC/EN61010-2-101

医用电气系统Medical electrical systems

IEC/EN 60601-1-1

警报系统alarm systems in medical electrical
equipment and medical electrical systems

IEC/EN 60601-1-8

高频手术设备High frequency surgical
equipment

IEC/EN 60601-2-2

神经和肌肉刺激器
Neuromuscular Stimulation Device

IEC/EN 60601-2-10

麻醉系统Anaesthetic systems

IEC/EN 60601-2-13

内窥镜Endoscopic equipment

IEC/EN 60601-2-18

心电图机Electrocardiographs

IEC/EN/UL  60601-1, IEC/EN 60601-2-25, IEC/EN 60601-2-51

无创血压监护Automated non-invasive sphygmomanometers

IEC/EN 60601-2-30

医用电热毯，褥和垫
Blankets, pads and mattresses, intended for heating in medical use

IEC/EN 60601-2-35

诊断超声设备Diagnostic Ultrasonic Device

IEC/EN  60601-1, IEC/EN 60601-2-37

治疗超声设备Therapeutic Ultrasonic Device

IEC/EN  60601-1, EN 60601-2-5

医院电动床Hospital Electric Bed

IEC/EN 60601-2-38, IEC/EN 60601-2-52

流动心电图机
Ambulatory electrocardiographic systems

IEC/EN 60601-2-47，EC38

多功能病人监护仪Multifunction Patient Monitor

IEC/EN/UL 60601-1,  IEC/EN 60601-2-27,  IEC/EN 60601-2-30,  IEC/EN 60601-2-34, IEC/EN 60601-2-49,  ISO 9919, EN 12470-4

电子血压计Sphygmomanometer

EN1060-1, EN 1060-3，SP10

轮椅/电动代步车Wheelchairs / Electric Scooters

ISO 7176 Serial,EN 12183, EN 12184, GB 18029 serial

拐杖/ 助行器Walking Sticks / Walking Aids

ISO 11199 serial, ISO 11334 serial, EN 1985, BS 5205, BS 497, BS 5181, JIS T 9204

洗澡椅/ 便器椅Shower Chairs Sanitary Chairs

BS EN 12182, AS 3973

残疾人辅助器具
Technical Aids for Disabled Persons

BS EN 12182

医用温度计Clinical Termometer

IEC/EN 12470-3，IEC/EN 12470-5,ASTM E1965, ASTM_F1992

雾化器Nebulizer

IEC/EN/UL 60601-1, ISO 13544

牙科椅Dentist Chairs

ISO 6875

脑电图机Electroencephalograph

IEC/EN 60601-2-26

心电监护设备Diagnostic
electrocardiographic devices

EC11，EC13

诊断和治疗用激光设备Diagnostic and therapeutic laser equipment

IEC/EN 60601-2-22，IEC60825-1

电子肌动描记器及诱发反应electromyographs and evoked
response equipment

IEC/EN 60601-2-40