医疗器械技术文档清单

医疗器械技术文档清单医疗器械技术文档清单（DMRLIST）器材规格，包括适当的图样、成分、配方、零件规格及软体规格Devicespecificationsincludingappropriatedrawings,composition,formulation,componentspecifications,andsoftwarespecifications技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)设计输入ProductDesignInputPLPDI-XXXX-XXFORMCHECKBOXDHFFolder2)产品规格ProductDesignSpecificationPLPDS-XXXX-XXFORMCHECKBOXDHFFolder3)零件规格ComponentEvaluationReportXXXX-XXXXXFORMCHECKBOXDMRFolder4)塑胶件配方表FormulationControlReportXXXX-XXXFORMCHECKBOXDMRFolder5)图纸DrawingXXXX-XXXXXFORMCHECKBOXDMRFolder6)软件SoftwareFORMCHECKBOX7)使用该产品的适用标准AppropriateStandardXXXXXXXXXFORMCHECKBOXStandardFolder医疗器械技术文档清单全文共医疗器械技术文档清单全文共4页，当前为第1页。制程规格，包括适当的设备规格、生产方法、生产程序、及行产环境规格Productionprocessspecificationsincludingtheappropriateequipmentspecifications,productionmethods,productionprocedures,andproductionenvironmentspecifications技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)主要生产设备清单TheAppropriateEquipmentListPLPIE-MLT-XXXFORMCHECKBOXDMRFolder2)产品作业流程ProduceFlowChartPLC-XXXX-XXFORMCHECKBOXDMRFolder3)排拉表ProduceLinelayoutPLL-XXXX-XXFORMCHECKBOXDMRFolder3)产品工艺文件ManualEngineeringInstructionsMEI-XXXX-XXXFORMCHECKBOXDMRFolder4)产品的批号规定LotNoDefineInstructionEI-XXXXFORMCHECKBOXDMRFolder5)产品的灭菌方法和确认SterilizationmeansandvalidationFORMCHECKBOXDMRFolder6)灭菌验证SterilizationverificationFORMCHECKBOXDMRFolder7)培训程序ProcedureforTrainingPLQSP601FORMCHECKBOXQSPFolder8)一万级无尘房监控指引CleanroommonitorinstructionPLPIE-CWI-008FORMCHECKBOXCWIFolder9)设备维修与保养程序ProcedureforMaintenanceandRepairofDevicesPLQSP602FORMCHECKBOXQSPFolder10)制程控制程序ProcedureforProcessControlPLQSP704FORMCHECKBOXQSPFolder13)无尘房日常维护保养工作指示InstructionforCleanRoomMaintainPLPIE-CWI-039FORMCHECKBOXCWIFolder14)医疗产品转拉清拉工作指示InstructionforlinechangePLQAD-CWI-087FORMCHECKBOXCWIFolder医疗器械技术文档清单全文共医疗器械技术文档清单全文共4页，当前为第2页。品质保证程序及规格，包括允收基准及所使用的品保设备Qualityassuranceproceduresandspecificationsincludingacceptancecriteriaandthequalityassuranceequipmenttobeused技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)品质保证计划QualityAssurancePlanPLQAP-XXXX-XXFORMCHECKBOXDMRFolder2)产品质量控制工作指示QualityControlInstructionQCI-XXXX-XXFORMCHECKBOXDMRFolder3)产品测试计划ProductTestPlanPLPTP-XXXX-XXFORMCHECKBOXDMRFolder4)接受标准与检验方法PLQAD-XXXX-XXFORMCHECKBOXDMRFolder5)计量校准控制程序ProcedureforManagementandCalibrationPLQSP708FORMCHECKBOXQSPFolder6)来料检验和测试程序ProcedureforInspectionandTestofIncomingMaterialsPLQSP803FORMCHECKBOXQSPFolder7)制程检验与测试程序ProcedureforInspectionandTestofProcessPLQSP804FORMCHECKBOXQSPFolder8)最终检验与测试程序ProcedureforFinalInspectionandTestPLQSP810FORMCHECKBOXQSPFolder包装及标签规格，包括所使用的方法及程序Packagingandlabelingspecifications,includingmethodsandprocessesused技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)产品的标签、语言规定ProductLabeling,LanguagePLQAD-CWI-XXXFORMCHECKBOXDMRFolder2)标签LabelingFORMCHECKBOXDMRFolder3)使用说明书ManualFORMCHECKBOXDMRFolder4)包装作业指导书InstructionforpackageMEI-XXXX-XXFORMCHECKBOXDMRFolder5)医疗产品包装标识、标签、说明书控制工作指示Packing、Labeling、ManualcontrolinstructionPLQAD-CWI-086FORMCHECKBOXCWIFolder医疗器械技术文档清单全文共医疗器械技术文档清单全文共4页，当前为第3页。安装、保养、及服务程序和方法Installation,maintenance,andservicingproceduresandmethods技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1）货仓物料储存仓位指示StoremanagementInstructionPLSTO-CWI-00