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医疗器械CE认证标准有哪些？
发布时间：2020-12-29
| 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 |
亿博检测高级销售顾问certified engineer
刘巧 联系方式：13686173586 座机：0755-27958201
邮箱：liuqiao@ebotek.cn
地址：深圳市宝安区西乡街道银田工业区侨鸿盛文化创意园A栋219-220
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