受控文件未經(jīng)批準(zhǔn)不得復(fù)印第6頁共9頁模板編號：變更評估表ChangeassessmentForm變更編號ChangeNo.：FORMCHECKBOXECR23-02-2011FORMCHECKBOXPCNFORMCHECKBOXTCN（一）變更描述Changedescription變更標(biāo)題Changetitle：是否為臨時更改？Temporarychange:FORMCHECKBOX否NFORMCHECKBOX是Y，有效期/量Validperiodorvalidquantity：N/A變更負(fù)責(zé)人Changeowner：負(fù)責(zé)人部門Ownerdepartment：申請日期ApplicationDate：變更等級Changecriticality:FORMCHECKBOX較小MinorFORMCHECKBOX重要MajorFORMCHECKBOX重大Critical（二）變更評估Changeassessment序號No.變更來源Changesource變更點(diǎn)Changepoint變更理由Changereason變更方案Changeplan變更影響分析Changeanalysis風(fēng)險(xiǎn)評估Riskevaluation受影響范圍Affectedscope物料管理部CPU風(fēng)扇停產(chǎn)改代供應(yīng)商反饋CPU風(fēng)扇原型號后續(xù)會停產(chǎn)，因此需要新選型滿足要求的CPU風(fēng)扇硬件：新選型同品牌A70型號風(fēng)扇，新風(fēng)扇與舊風(fēng)扇規(guī)格差異如下：風(fēng)量由31.5CFM增加至36.7CFM；靜態(tài)風(fēng)壓由1.77H2O增加至1.79H2O；額定電流由0.2A降低至0.109A；功率由2.4W降低至1.3W；高度由55mm增加至57mm；其余規(guī)格一致。硬件：輸出新選型風(fēng)扇規(guī)格書設(shè)轉(zhuǎn)：升版整機(jī)BOM，更改CPU風(fēng)扇料號，風(fēng)扇安裝結(jié)構(gòu)并未改變，高度2mm的增加，不涉及裝配方法的更改測試：進(jìn)行功能測試，詳見《R-02-20061-01變更測試報(bào)告》產(chǎn)品安全：對變更后的樣機(jī)進(jìn)行安規(guī)EMC測試，輸出《R-02-20063-01安規(guī)、EMC測試報(bào)告（ECR23-02-2011）》FORMCHECKBOX涉及，參見：FORMCHECKBOX不涉及，說明理由：新選型風(fēng)扇散熱能力優(yōu)于原型號，固定方式可兼容，不影響產(chǎn)品功能和性能，不涉及臨床和安全風(fēng)險(xiǎn)。（國內(nèi)）、（國際NMPA證地區(qū)）受控文件未經(jīng)批準(zhǔn)不得復(fù)印第9頁共9頁模板編號：（三）有源器械影響分析評估列表Impactassessmentchecklistofactivedevice評估模塊Assessmentmodule評估內(nèi)容Assessmentcontent影響Affected不影響Notaffected受影響變更點(diǎn)Impactedchangepoint整體評估OverallevaluationDMR、DHF清單DMR,DHFlistFORMCHECKBOXFORMCHECKBOX1-4、6-10用戶需求、設(shè)計(jì)輸入U(xiǎn)RS,DesigninputFORMCHECKBOXFORMCHECKBOXN/A軟件Software軟件代碼、安裝包、操作界面Softwarecode,Installpackage,OperationinterfaceFORMCHECKBOXFORMCHECKBOX2-4子方向驗(yàn)證SubdirectionverificationFORMCHECKBOXFORMCHECKBOX2-4硬件Hardware產(chǎn)品PCB、PCBA、元器件、FPGA、插裝圖PCB,PCBA,Components,FPGA,PlugindiagramFORMCHECKBOXFORMCHECKBOX10子方向驗(yàn)證SubdirectionverificationFORMCHECKBOXFORMCHECKBOX10結(jié)構(gòu)Structure產(chǎn)品結(jié)構(gòu)、共模件Productstructure,CommonmoduleFORMCHECKBOXFORMCHECKBOXN/A子方向驗(yàn)證SubdirectionverificationFORMCHECKBOXFORMCHECKBOXN/A設(shè)計(jì)驗(yàn)證和確認(rèn)Designverificationandvalidation可靠性及系統(tǒng)驗(yàn)證reliabilityandsystemverificationFORMCHECKBOXFORMCHECKBOX1-4、6、8-10環(huán)境EnvironmentFORMCHECKBOXFORMCHECKBOXN/A安規(guī)、EMCSafety,EMCFORMCHECKBOXFORMCHECKBOX1、2、3、8、10關(guān)鍵物料/關(guān)鍵元器件Keymaterial,KeycomponentsFORMCHECKBOXFORMCHECKBOXN/A生物相容性BiocompatibilityFORMCHECKBOXFORMCHECKBOXN/A設(shè)備和導(dǎo)管的相互影響TheinterplaybetweenequipmentandcatheterFORMCHECKBOXFORMCHECKBOXN/A臨床評估ClinicevaluationFORMCHECKBOXFORMCHECKBOXN/A工藝Process生產(chǎn)流程ProductionprocessFORMCHECKBOXFORMCHECKBOXN/ADHR模版DHRtemplateFORMCHECKBOXFORMCHECKBOX5生產(chǎn)工藝、檢驗(yàn)工藝、通用工藝、維修配件檢測工藝Productionprocess,Testprocess,Generalprocess,MaintenanceaccessoryFORMCHECKBOXFORMCHECKBOX4、7、8、9特殊過程確認(rèn)、工藝確認(rèn)/驗(yàn)證Specialprocessvalidation,Processqualification/verificationFORMCHECKBOXFORMCHECKBOXN/A法規(guī)/注冊Regulations/registration標(biāo)準(zhǔn)、法規(guī)的更新UpdateofStandardsandregulationsFORMCHECKBOXFORMCHECKBOXN/A產(chǎn)品規(guī)格變更、注冊變更Productspecifications,RegistrationchangeFORMCHECKBOXFORMCHECKBOXN/A告知主管、公告機(jī)構(gòu)Informthecompetentauthoritiesand/orthenotifiedbodyFORMCHECKBOXFORMCHECKBOXN/A物料MaterialBOMFORMCHECKBOXFORMCHECKBOX1-4、6、8、10物料變更、新增物料Materialchange,NewaddedmaterialFORMCHECKBOXFORMCHECKBOX1-4、6、8、10供應(yīng)商變更SupplierchangeFORMCHECKBOXFORMCHECKBOX2產(chǎn)品包裝方式、包材Mannerofpacking,PackingmaterialFORMCHECKBOXFORMCHECKBOXN/A產(chǎn)品標(biāo)簽、外箱標(biāo)簽Productlabel,CartoonlabelFORMCHECKBOXFORMCHECKBOXN/A操作手冊、說明書Operationmanual,UserinstructionFORMCHECKBOXFORMCHECKBOXN/A不同產(chǎn)品共用物料CommonmaterialofdifferentproductsFORMCHECKBOXFORMCHECKBOXN/A物料處置MaterialhandleFORMCHECKBOXFORMCHECKBOX1-3、6、8、10物料防護(hù)要求變更、有效期管控物料清單更改Materialprotectionrequirementchange,ValiditycontrolBOMchangeFORMCHECKBOXFORMCHECKBOX1、2、3、8、10物料計(jì)劃/銷售配置/維修備件計(jì)劃MaterialPlan,Salesconfiguration,SparepartsplanFORMCHECKBOXFORMCHECKBOXN/A產(chǎn)品配附件、耗材更改或影響其使用Productaccessories,ConsumablesoraffectinguseFORMCHECKBOXFORMCHECKBOXN/A工程更改變更維修物料兼容性分析AssessmentofcompatibilityofmaterialsinfluencedbyengineeringchangesFORMCHECKBOXFORMCHECKBOXN/A設(shè)備設(shè)施Equipmentandfacilities測試工裝、生產(chǎn)工裝、設(shè)備Testingfixture,Productionfixture,EquipmentFORMCHECKBOXFORMCHECKBOX10工裝配置文件ToolingconfigurationfileFORMCHECKBOXFORMCHECKBOXN/A裝配夾具、檢具、模具Assemblyfixture,Inspectiontools,MouldFORMCHECKBOXFORMCHECKBOX9廠房設(shè)施PlantfacilitiesFORMCHECKBOXFORMCHECKBOXN/A風(fēng)險(xiǎn)管理文檔Riskmanagementfile過程風(fēng)險(xiǎn)管理跟蹤表TracingtableofriskmanagementactivitiesFORMCHECKBOXFORMCHECKBOXN/A風(fēng)險(xiǎn)管理計(jì)劃和報(bào)告RiskmanagementplanandreportFORMCHECKBOXFORMCHECKBOXN/A市場/服務(wù)Market/Service培訓(xùn)資料、市場宣傳資料Trainingmaterials,MarketingmaterialsFORMCHECKBOXFORMCHECKBOXN/A告知進(jìn)口商N(yùn)otifyImporterFORMCHECKBOXFORMCHECKBOXN/A可維護(hù)性、物料兼容性Maintainability,MaterialcompatibilityFORMCHECKBOXFORMCHECKBOXN/A維修手冊、安裝手冊Maintenancemanual,InstallationmanualFORMCHECKBOXFORMCHECKBOXN/AEHS環(huán)境/健康/安全Environment/Healthy/SafetyFORMCHECKBOXFORMCHECKBOXN/A過程軟件Processsoftware系統(tǒng)數(shù)據(jù)更新UpdateofsystemdataFORMCHECKBOXFORMCHECKBOXN/A過程軟件確認(rèn)ValidationofprocesssoftwareFORMCHECKBOXFORMCHECKBOXN/A（四）評估團(tuán)隊(duì)EvaluationTeam必選職能Requiredfunctions職能Function評估人Appraiser簽名/日期Signature/Date負(fù)責(zé)人部門主管及以上質(zhì)量可選職能Optional