|
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 6 |
|
警报系统alarm systems in medical electrical
equipment and medical electrical systems
|
IEC/EN 6 |
|
高频手术设备High frequency surgical
equipment
|
IEC/EN 6 |
|
神经和肌肉刺激器
Neuromuscular Stimulation Device
|
IEC/EN 6 |
|
麻醉系统Anaesthetic systems |
IEC/EN 6 |
|
内窥镜Endoscopic equipment |
IEC/EN 6 |
|
心电图机Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN 6 |
|
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 6 |
|
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 6 |
|
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 6 |
|
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 6 |
|
电子肌动描记器及诱发反应electromyographs and evoked
response equipment
|
IEC/EN 60601-2-40 |
