文稿說明講稿jasun technical file

恒摯醫(yī)療設備（）JasunMedicalEquipment(Shanghai)Co.,CETechnicalCEDraftedby編制:Reviewedby審核張ApprovedbyIdentification文件編號生效日期:JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:Chapter:AccordingtoMedicalDirective,93/42/EEC,Annex PartChapter:1AdministrativeInformation公司信 Chapter:2MDDAgreement歐代協(xié) Chapter:3ECDeclarationofConformity符合性...........................................................Chapter:4ofQualitySystem質量系統(tǒng)........................................................ Chapter:8Productlabel,manual產品和使用說明 ofConformity(product/material)產品和/或材料...................13Chapter:10Applicablestandards協(xié)調標準.................................................................14 PartChapter:12Productmanufactures(e.g.drawing,Manufactureflowchart產品的生產文件（圖紙，流程圖 Chapter:16postmarketsuvillanceSystem產品上市系統(tǒng).18Error!Bookmarknot JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:英文：JasunMedicalEquipment(Shanghai)Co.,中文：恒摯醫(yī)療設備（）英文：598KeshengRoadBlock1Shanghai201802,:Fax傳真 JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter2MDDAgreementWhentheproduct(OperatingLights)wouldbeputintoEuropeanMarketwithmyownname--?JasunMedicalEquipment(Shanghai)Co.,.?asmanufacturer,theMDDAgreementwithEUauthorizedrepresentativewillbeprovided.附件1：無影燈產品介紹；JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter3ECDeclarationofConformityECJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter4QualitySystemEN13485JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter5ProductDescriptionProductName產品名稱Typename:OperatingIntendedUse預期用途Thesurgicallightsareintendedforlocalilluminationwithintheoperatingroomand/ortreatmentroominHospital,forsupportingthepatientduringexamination.Description:描述(IncludingnnedMoreandmorelightsourcesproduceanoshadowThesystemconsistsofCanopy,Revolver,SpringBalancerand5.4.35.4.3Photo:ConfiguredprofessionalbalancerwillmakestableandreliablebalanceofthelightStreamlinedesignwithlowerairdampcoefficientmaybeusedinhigh-demandpurifyingoperatingroom.Thedevicemadeupoflight-weightedmaterialsmayprovidemoreportableandmoreflexibleoperation.Disinfectedadjustinghandlewillguaranteefaculamicro-adjustmentperformedintheprocessoftheoperationtokeepinasepsisstatus.5.4.5Accessories產品附件Disinfectionproductpackingandlifetime產品包裝和WoodenboxorCartonbox-harmlesstotheenvironmentandmayberecycled,shouldbecarriedtoappointedrecyclable Cinnamenepackingmaterials, sticbags——harmfultotheenvironment,andshouldbecarriedtoappointedinrecyclable cesandthenhandledcollectively.JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:ClassificationoftheproductProduct:OperatingClassificationaccordingtosectionIIIofAnnexIX,MDDRULEAllotheractivedevicesareinClassClassJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter7ProductSpecification1Power2Power3Input4Illuminationintensity5Color6ColorrenderingindexJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartA,Chapter:8Productlabelandmanual產品和使用JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartA,Chapter:9ofConformity(productJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:(Harmonizedstandards,internationalstandards,partlyapplicablestandards)Relevantstandards:產品相關執(zhí)行標準EN980:EN1041:2008ENISOEN60601-1:2006ENJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartAChapter11Test&VerificationReportsSeeSafetyofmedicalelectricalequipmenttestingofthedevicewasperformedinaccordancewithtechnicalstandardsapplied.Refertothefollowingprotocolsandreports.Title標準號 Number測試報告號Electricalcompatibilitytestingofthedevicewasperformedinaccordancewiththetechnicalstandardsapplied.Refertothefollowingprotocolsandreports.Title標準號 Number測試報告號 ENISO10993- .Thedevicewasevaluatedagainstthestandardsapplied.Refertothefollowingreportsforthescenariostested.Title Number Other:ifTitle Number 產品Remark:Testreportbasedonfactoryinternalstandardfortransportationand8JasunMedicalEquipment(Shanghai)Technical.Version:PartB,Chapter:12ProductsRefertothefollowingforadditional無影燈工藝流程 1JSB-HAL-2JSB-LED-3JSB-LED9-4JSB-LED600-5JSB-HAL-6JSB-LED-7JSB-LED9-8JSB-LED600-91234512.2.Materials:材料（包括化學生物材料RefertoBOMfileidentificationSeeElectricalDrawingsno.JSB-HAL-006/JSB-LED-006/JSB-LED9-006/JSB-Mechanicaldrawinglistno.JSB-HAL-006/JSB-LED-006/JSB-LED9-006/JSB- PackagingmaterialspecificationWIJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:AccordingtoMDD93/42/EECAnnex1根據(jù)MDD93/42/EECJasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartB,Chapter:14Riskysis風險分析報AccordingtoISO14971:2012ISO14971標準附件9JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:PartBChapter15clinical JasunMedicalEquipment(Shanghai)Co.,TechnicalVersion:16.PostMarketThefollowingprocedurescoverpostmarketsurveillanceandvigilancereporting:Refertothefollowing:Title NumberComintHandling Vigilancesystem 警戒事故流 (93/42/EECMDDAnnexha