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医疗器械产品 |
测试标准 |
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所有的医用电气设备 Allthemedicalelectricalequipment |
IEC/EN60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
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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 |
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警报系统 alarm systemsinmedicalelectrical equipmentandmedical electrical systems |
IEC/EN60601-1-8 |
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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 |
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麻醉系统 Anaesthetic systems |
IEC/EN60601-2-13 |
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内窥镜 Endoscopic equipment |
IEC/EN60601-2-18 |
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心电图机 Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN60601-2-25, IEC/EN60601-2-51 |
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无创血压监护 Automated non-invasive sphygmomanometers |
IEC/EN60601-2-30 |
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医用电热毯，褥和垫 Blankets,padsandmattresses, ntended forheatinginmedicaluse |
IEC/EN60601-2-35 |
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诊断超声设备 DiagnosticUltrasonicDevice |
IEC/EN 60601-1, IEC/EN60601-2-37 |
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治疗超声设备 TherapeuticUltrasonic Device |
IEC/EN 60601-1, EN60601-2-5 |
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医院电动床 HospitalElectricBed |
IEC/EN60601-2-38, IEC/EN60601-2-52 |
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流动心电图机 Ambulatoryelectrocardiographicsystems |
IEC/EN60601-2-47,EC38 |
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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 |
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电子血压计 Sphygmomanometer |
EN1060-1,EN1060-3,SP10 EN1060-1,EN1060-3,SP10 |
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轮椅/电动代步车 Wheelchairs/Electric Scooters |
ISO7176Serial, EN12183,EN12184, GB18029serial |
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拐杖/助行器 WalkingSticks/WalkingAids |
ISO11199serial, ISO11334serial, EN1985,BS5205,BS497,BS5181, JIST9204 |
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洗澡椅/便器椅 ShowerChairs/SanitaryChairs |
BSEN12182,AS3973 |
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残疾人辅助器具 TechnicalAids forDisabledPersons |
BSEN12182 |
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医用温度计 ClinicalTermometer |
IEC/EN12470-3, IEC/EN12470-5, ASTME1965, ASTM_F1992 |
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雾化器 Nebulizer |
IEC/EN/UL60601-1, ISO13544 |
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牙科椅 DentistChairs |
ISO6875 |
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脑电图机 Electroencephalograph |
IEC/EN60601-2-26 |
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心电监护设备 Diagnostic electrocardiographicdevices |
EC11,EC13 |
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诊断和治疗用激光设备Diagnostic and therapeuticlaserequipment |
IEC/EN60601-2-22, IEC60825-1 |
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电子肌动描记器及诱发反应electromyographs and evoked responseequipment |
IEC/EN60601-2-40 |
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