医疗器械欧盟CE认证标准介绍

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 vitrodiagnostic (IVD)equipment

　　IEC/EN61010-1,

　　IEC/EN61010-2-101

　　医用电气系统 Medical electricalsystems

　　IEC/EN60601-1-1

　　警报系统 alarm systemsinmedicalelectrical

　　equipmentandmedical 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 NeuromuscularStimulationDevice 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,padsandmattresses,

　　ntended forheatinginmedicaluse

　　IEC/EN60601-2-35

　　诊断超声设备 DiagnosticUltrasonicDevice

　　IEC/EN 60601-1,

　　IEC/EN60601-2-37

　　治疗超声设备 TherapeuticUltrasonic Device

　　EN60601-2-5

　　医院电动床 HospitalElectricBed

　　IEC/EN60601-2-38,

　　IEC/EN60601-2-52

　　流动心电图机 Ambulatoryelectrocardiographicsystems

　　IEC/EN60601-2-47,EC38

　　多功能 MultifunctionPatient 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

　　ISO7176Serial,

　　EN12183,EN12184,

　　GB18029serial

　　拐杖/助行器 WalkingSticks/WalkingAids

　　ISO11199serial,

　　ISO11334serial,

　　EN1985,BS5205,

　　BS497,BS5181,

　　JIST9204

　　洗澡椅/便器椅 ShowerChairs/SanitaryChairs

　　BSEN12182,AS3973

　　残疾人辅助器具 TechnicalAids forDisabledPersons

　　BSEN12182

　　医用温度计 ClinicalTermometer

　　IEC/EN12470-3,

　　IEC/EN12470-5,

　　ASTME1965,

　　ASTM_F1992

　　雾化器 Nebulizer

　　ISO13544

　　牙科椅 DentistChairs

　　ISO6875

　　脑电图机 Electroencephalograph

　　IEC/EN60601-2-26