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醫療器械產品 |
測試標準 |
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所有的醫用電氣設備 Allthemedicalelectricalequipment |
IEC/EN60601-1 2nd Ed, IEC/EN60601-1 3rd Ed |
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體外診斷設備 In vitrodiagnostic (IVD)equipment |
IEC/EN61010-1, IEC/EN61010-2-101 |
| 醫用電氣系統 Medical electricalsystems |
IEC/EN60601-1-1 |
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警報系統 alarm systemsinmedicalelectrical equipmentandmedical electrical systems |
IEC/EN60601-1-8 |
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高頻手術設備 High frequency surgical equipment |
IEC/EN60601-2-2 |
| 神經和肌肉刺激器 NeuromuscularStimulationDevice |
IEC/EN60601-2-10 |
|
麻醉系統 Anaesthetic systems |
IEC/EN60601-2-13 |
|
內窺鏡 Endoscopic equipment |
IEC/EN60601-2-18 |
|
心電圖機 Electrocardiographs |
IEC/EN/UL 60601-1, IEC/EN60601-2-25, IEC/EN60601-2-51 |
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無創血壓監護 Automated non-invasive sphygmomanometers |
IEC/EN60601-2-30 |
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醫用電熱毯，褥和墊 Blankets,padsandmattresses, ntended forheatinginmedicaluse |
IEC/EN60601-2-35 |
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診斷超聲設備 DiagnosticUltrasonicDevice |
IEC/EN 60601-1, IEC/EN60601-2-37 |
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治療超聲設備 TherapeuticUltrasonic Device |
IEC/EN 60601-1, EN60601-2-5 |
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醫院電動床 HospitalElectricBed |
IEC/EN60601-2-38, IEC/EN60601-2-52 |
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流動心電圖機 Ambulatoryelectrocardiographicsystems |
IEC/EN60601-2-47,EC38 |
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多功能病人監護儀 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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電子血壓計 Sphygmomanometer |
EN1060-1,EN1060-3,SP10 EN1060-1,EN1060-3,SP10 |
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輪椅/電動代步車 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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殘疾人輔助器具 TechnicalAids forDisabledPersons |
BSEN12182 |
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醫用溫度計 ClinicalTermometer |
IEC/EN12470-3, IEC/EN12470-5, ASTME1965, ASTM_F1992 |
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霧化器 Nebulizer |
IEC/EN/UL60601-1, ISO13544 |
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牙科椅 DentistChairs |
ISO6875 |
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腦電圖機 Electroencephalograph |
IEC/EN60601-2-26 |
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心電監護設備 Diagnostic electrocardiographicdevices |
EC11,EC13 |
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診斷和治療用激光設備Diagnostic and therapeuticlaserequipment |
IEC/EN60601-2-22, IEC60825-1 |
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電子肌動描記器及誘發反應electromyographs and evoked responseequipment |
IEC/EN60601-2-40 |
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