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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

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