醫(yī)療器械技術(shù)-清單

醫(yī)療器械技術(shù)-清單醫(yī)療器械技術(shù)文檔清單（DMRLIST）器材規(guī)格，包括適當?shù)膱D樣、成分、配方、零件規(guī)格及軟體規(guī)格Devicespecificationsincludingappropriatedrawings,composition,formulation,componentspecifications,andsoftwarespecifications技術(shù)文件Devicemasterrecord文件編號Doc.NoApplyornot保存位置Location1)設(shè)計輸入ProductDesignInputPLPDI-XXXX-XXDHFFolder2)產(chǎn)品規(guī)格ProductDesignSpecificationPLPDS-XXXX-XXDHFFolder3)零件規(guī)格ComponentEvaluationReportXXXX-XXXXXDMRFolder4)塑膠件配方表FormulationControlReportXXXX-XXXDMRFolder醫(yī)療器械技術(shù)-清單全文共7頁，當前為第1頁。5)圖紙醫(yī)療器械技術(shù)-清單全文共7頁，當前為第1頁。XXXX-XXXXXDMRFolder6)軟件Software7)使用該產(chǎn)品的適用標準AppropriateStandardXXXXXXXXXStandardFolder制程規(guī)格，包括適當?shù)脑O(shè)備規(guī)格、生產(chǎn)方法、生產(chǎn)程序、及行產(chǎn)環(huán)境規(guī)格Productionprocessspecificationsincludingtheappropriateequipmentspecifications,productionmethods,productionprocedures,andproductionenvironmentspecifications技術(shù)文件Devicemasterrecord文件編號Doc.NoApplyornot保存位置Location1)主要生產(chǎn)設(shè)備清單TheAppropriateEquipmentListPLPIE-MLT-XXXDMRFolder2)產(chǎn)品作業(yè)流程ProduceFlowChartPLC-XXXX-XXDMRFolder3)排拉表ProduceLinelayoutPLL-XXXX-XXDMRFolder醫(yī)療器械技術(shù)-清單全文共7頁，當前為第2頁。3)產(chǎn)品工藝文件醫(yī)療器械技術(shù)-清單全文共7頁，當前為第2頁。MEI-XXXX-XXXDMRFolder4)產(chǎn)品的批號規(guī)定LotNoDefineInstructionEI-XXXXDMRFolder5)產(chǎn)品的滅菌方法和確認SterilizationmeansandvalidationDMRFolder6)滅菌驗證SterilizationverificationDMRFolder7)培訓程序ProcedureforTrainingPLQSP601QSPFolder8)一萬級無塵房監(jiān)控指引CleanroommonitorinstructionPLPIE-CWI-008CWIFolder9)設(shè)備維修與保養(yǎng)程序ProcedureforMaintenanceandRepairofDevicesPLQSP602QSPFolder10)制程控制程序ProcedureforProcessControlPLQSP704QSPFolder醫(yī)療器械技術(shù)-清單全文共7頁，當前為第3頁。13)無塵房日常維護保養(yǎng)工作指示InstructionforCleanRoomMaintain醫(yī)療器械技術(shù)-清單全文共7頁，當前為第3頁。PLPIE-CWI-039CWIFolder14)醫(yī)療產(chǎn)品轉(zhuǎn)拉清拉工作指示InstructionforlinechangePLQAD-CWI-087CWIFolder品質(zhì)保證程序及規(guī)格，包括允收基準及所使用的品保設(shè)備Qualityassuranceproceduresandspecificationsincludingacceptancecriteriaandthequalityassuranceequipmenttobeused技術(shù)文件Devicemasterrecord文件編號Doc.NoApplyornot保存位置Location1)品質(zhì)保證計劃QualityAssurancePlanPLQAP-XXXX-XXDMRFolder2)產(chǎn)品質(zhì)量控制工作指示QualityControlInstructionQCI-XXXX-XXDMRFolder3)產(chǎn)品測試計劃ProductTestPlanPLPTP-XXXX-XXDMRFolder醫(yī)療器械技術(shù)-清單全文共7頁，當前為第4頁。4)醫(yī)療器械技術(shù)-清單全文共7頁，當前為第4頁。PLQAD-XXXX-XXDMRFolder5)計量校準控制程序ProcedureforManagementandCalibrationPLQSP708QSPFolder6)來料檢驗和測試程序ProcedureforInspectionandTestofIncomingMaterialsPLQSP803QSPFolder7)制程檢驗與測試程序ProcedureforInspectionandTestofProcessPLQSP804QSPFolder8)最終檢驗與測試程序ProcedureforFinalInspectionandTestPLQSP810QSPFolder包裝及標簽規(guī)格，包括所使用的方法及程序Packagingandlabelingspecifications,includingmethodsandprocessesused技術(shù)文件Devicemasterrecord文件編號Doc.NoApplyornot保存位置Location醫(yī)療器械技術(shù)-清單全文共7頁，當前為第5頁。1)產(chǎn)品的標簽、語言規(guī)定醫(yī)療器械技術(shù)-清單全文共7頁，當前為第5頁。PLQAD-CWI-XXXDMRFolder2)標簽LabelingDMRFolder3)使用說明書ManualDMRFolder4)包裝作業(yè)指導書InstructionforpackageMEI-XXXX-XXDMRFolder5)醫(yī)療產(chǎn)品包裝標識、標簽、說明書控制工作指示Packing、Labeling、ManualcontrolinstructionPLQAD-CWI-086CWIFolder安裝、保養(yǎng)、及服務(wù)程序和方法Installation,maintenance,andservicingproceduresandmethods技術(shù)文件Devicemasterrecord文件編號Doc.NoApplyornot保存位置Location1）貨倉物料儲存?zhèn)}位指示StoremanagementInstructionPLSTO-C