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以下是医疗器械欧盟认证标准一览表:
所有的医用电气设备:
- IEC/EN60601-1 2nd Ed,
- IEC/EN60601-1 3rd Ed
体外诊断设备:
- 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/EN60601-1-1
警报系统 alarm systems in medical electrical equipment and medical electrical systems:
- IEC/EN60601-1-8
高频手术设备:
- High frequency surgical equipment
- IEC/EN60601-2-2
神经和肌肉刺激器:
- Neuromuscular Stimulation Device
- IEC/EN60601-2-10
麻醉系统:
- Anaesthetic systems
- IEC/EN60601-2-13
内窥镜:
- Endoscopic equipment
- IEC/EN60601-2-18
心电图机:
- Electrocardiographs
- IEC/EN/UL 60601-1,
- IEC/EN60601-2-25,
- IEC/EN60601-2-51
无创血压监护:
- Automated non-invasive sphygmomanometers
- IEC/EN60601-2-30
医用电热毯,褥和垫 Blankets, pads and mattresses, intended for heating in medical use:
- IEC/EN60601-2-35
诊断超声设备:
- Diagnostic Ultrasonic Device
- IEC/EN 60601-1,
- IEC/EN60601-2-37
治疗超声设备:
- Therapeutic Ultrasonic Device
- IEC/EN 60601-1,
- EN60601-2-5
医院电动床:
- Hospital Electric Bed
- IEC/EN60601-2-38,
- IEC/EN60601-2-52
流动心电图机:
- Ambulatory electrocardiographic systems
- IEC/EN60601-2-47,EC38
多功能病人监护仪:
- Multifunction Patient Monitor
- IEC/EN/UL60601-1,
- IEC/EN60601-2-27,
- IEC/EN60601-2-30,
- IEC/EN60601-2-34,
- IEC/EN60601-2-49,
- ISO9919,EN12470-4
电子血压计:
- Sphygmomanometer
- EN1060-1,EN1060-3,SP10
轮椅/电动代步车:
- Wheelchairs/Electric Scooters
- ISO7176 Serial,
- EN12183,EN12184,
- GB18029 Serial
拐杖/助行器:
- Walking Sticks/Walking Aids
- ISO11199 Serial,
- ISO11334 Serial,
- EN1985,BS5205,
- BS497,BS5181,
- JIST9204
洗澡椅/便器椅:
- Shower Chairs/Sanitary Chairs
- BSEN12182,AS3973
残疾人辅助器具:
- Technical Aids for Disabled Persons
- BSEN12182
60601-2-40