医疗器械CE认证标准有哪些？

医疗器械CE认证标准有哪些？医疗器械产品测试标准所有的医用电气设备 Allthemedicalelectricalequipment IEC/EN60601-1 2nd Ed, IEC/EN60601-1 3rd Ed 体外诊断设备 In vitrodiagnostic (IVD)equipment IEC/EN61010-..

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医疗器械CE认证标准有哪些？

发布时间：2020-12-29 热度：

医疗器械CE认证标准有哪些？

医疗器械产品	测试标准
所有的医用电气设备 Allthemedicalelectricalequipment	IEC/EN60601-1 2nd Ed, IEC/EN60601-1 3rd Ed
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	IEC/EN 60601-1, 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
多功能病人监护仪 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 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	IEC/EN/UL60601-1, ISO13544
牙科椅 DentistChairs	ISO6875
脑电图机 Electroencephalograph	IEC/EN60601-2-26
心电监护设备 Diagnostic electrocardiographicdevices	EC11,EC13
诊断和治疗用激光设备Diagnostic and therapeuticlaserequipment	IEC/EN60601-2-22, IEC60825-1
电子肌动描记器及诱发反应electromyographs and evoked responseequipment	IEC/EN60601-2-40