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醫(yī)療器械CE認(rèn)證標(biāo)準(zhǔn)有哪些?

瀏覽次數(shù): | 2020-12-29 14:01

佛山億博機(jī)械CE認(rèn)證中心是一家專業(yè)做機(jī)械產(chǎn)品CE認(rèn)證, 已有超過(guò)十年的檢測(cè)認(rèn)證經(jīng)驗(yàn),機(jī)械CE認(rèn)證請(qǐng)認(rèn)準(zhǔn)億博檢測(cè),服務(wù)熱線:135-3022-3279



醫(yī)療器械產(chǎn)品 測(cè)試標(biāo)準(zhǔn)
所有的醫(yī)用電氣設(shè)備 Allthemedicalelectricalequipment  IEC/EN60601-1 2nd Ed,
IEC/EN60601-1 3rd Ed
體外診斷設(shè)備 In vitrodiagnostic (IVD)equipment IEC/EN61010-1,
IEC/EN61010-2-101
醫(yī)用電氣系統(tǒng) Medical electricalsystems IEC/EN60601-1-1
警報(bào)系統(tǒng) alarm systemsinmedicalelectrical
 equipmentandmedical electrical systems
IEC/EN60601-1-8
高頻手術(shù)設(shè)備 High frequency surgical equipment IEC/EN60601-2-2
神經(jīng)和肌肉刺激器 NeuromuscularStimulationDevice IEC/EN60601-2-10
麻醉系統(tǒng) Anaesthetic systems IEC/EN60601-2-13
內(nèi)窺鏡 Endoscopic equipment IEC/EN60601-2-18
心電圖機(jī) Electrocardiographs IEC/EN/UL 60601-1, 
IEC/EN60601-2-25, 
IEC/EN60601-2-51
無(wú)創(chuàng)血壓監(jiān)護(hù) Automated non-invasive sphygmomanometers IEC/EN60601-2-30
 醫(yī)用電熱毯,褥和墊 Blankets,padsandmattresses,
ntended forheatinginmedicaluse
IEC/EN60601-2-35
診斷超聲設(shè)備 DiagnosticUltrasonicDevice IEC/EN 60601-1,
IEC/EN60601-2-37
治療超聲設(shè)備 TherapeuticUltrasonic Device IEC/EN 60601-1, 
EN60601-2-5
醫(yī)院電動(dòng)床 HospitalElectricBed IEC/EN60601-2-38, 
IEC/EN60601-2-52
流動(dòng)心電圖機(jī) Ambulatoryelectrocardiographicsystems IEC/EN60601-2-47,EC38
多功能病人監(jiān)護(hù)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
電子血壓計(jì) Sphygmomanometer EN1060-1,EN1060-3,SP10  
EN1060-1,EN1060-3,SP10  
輪椅/電動(dòng)代步車 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
殘疾人輔助器具 TechnicalAids forDisabledPersons BSEN12182
醫(yī)用溫度計(jì) ClinicalTermometer IEC/EN12470-3, 
IEC/EN12470-5, 
ASTME1965, 
ASTM_F1992
霧化器 Nebulizer IEC/EN/UL60601-1,
ISO13544
牙科椅 DentistChairs ISO6875
腦電圖機(jī) Electroencephalograph IEC/EN60601-2-26
心電監(jiān)護(hù)設(shè)備 Diagnostic electrocardiographicdevices EC11,EC13
診斷和治療用激光設(shè)備Diagnostic and therapeuticlaserequipment IEC/EN60601-2-22, 
IEC60825-1
電子肌動(dòng)描記器及誘發(fā)反應(yīng)electromyographs and evoked responseequipment IEC/EN60601-2-40


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劉巧 2009年進(jìn)入億博檢測(cè)技術(shù)有限公司,擔(dān)任高級(jí)技術(shù)顧問(wèn)。
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