医疗器械技术文档
(DMRLIST) 1、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.No Applyornot 保存位置Location 1)设计输入ProductDesignInput PLPDI-XXXX-XX FORMCHECKBOX DHFFolder 2)产品规格ProductDesignSpecification PLPDS-XXXX-XX FORMCHECKBOX DHFFolder 3)零件规格ComponentEvaluationReport XXXX-XXXXX FORMCHECKBOX DMRFolder 4)塑胶件配方
FormulationControlReport XXXX-XXX FORMCHECKBOX DMRFolder 5)图纸Drawing XXXX-XXXXX FORMCHECKBOX DMRFolder 6)软件Software FORMCHECKBOX 7)使用该产品的适用标准AppropriateStandard XXXXXXXXX FORMCHECKBOX StandardFolder 2、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.No Applyornot 保存位置Location 1)主要生产设备清单TheAppropriateEquipmentList PLPIE-MLT-XXX FORMCHECKBOX DMRFolder 2)产品作业
ProduceFlowChart PLC-XXXX-XX FORMCHECKBOX DMRFolder 3)排拉表ProduceLinelayout PLL-XXXX-XX FORMCHECKBOX DMRFolder 3)产品工艺文件ManualEngineeringInstructions MEI-XXXX-XXX FORMCHECKBOX DMRFolder 4)产品的批号规定LotNoDefineInstruction EI-XXXX FORMCHECKBOX DMRFolder 5)产品的灭菌方法和确认Sterilizationmeansandvalidation FORMCHECKBOX DMRFolder 6)灭菌验证Sterilizationverification FORMCHECKBOX DMRFolder 7)培训程序ProcedureforTraining PLQSP601 FORMCHECKBOX QSPFolder 8)一万级无尘房监控指引Cleanroommonitorinstruction PLPIE-CWI-008 FORMCHECKBOX CWIFolder 9)设备维修与保养程序ProcedureforMaintenanceandRepairofDevices PLQSP602 FORMCHECKBOX QSPFolder 10)制程控制程序ProcedureforProcessControl PLQSP704 FORMCHECKBOX QSPFolder 13)无尘房日常维护保养工作指示InstructionforCleanRoomMaintain PLPIE-CWI-039 FORMCHECKBOX CWIFolder 14)医疗产品转拉清拉工作指示Instructionforlinechange PLQAD-CWI-087 FORMCHECKBOX CWIFolder 3、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.No Applyornot 保存位置Location 1)品质保证
QualityAssurancePlan PLQAP-XXXX-XX FORMCHECKBOX DMRFolder 2)产品质量控制工作指示QualityControlInstruction QCI-XXXX-XX FORMCHECKBOX DMRFolder 3)产品测试计划ProductTestPlan PLPTP-XXXX-XX FORMCHECKBOX DMRFolder 4)接受标准与检验方法 PLQAD-XXXX-XX FORMCHECKBOX DMRFolder 5)计量校准控制程序ProcedureforManagementandCalibration PLQSP708 FORMCHECKBOX QSPFolder 6)来料检验和测试程序ProcedureforInspectionandTestofIncomingMaterials PLQSP803 FORMCHECKBOX QSPFolder 7)制程检验与测试程序ProcedureforInspectionandTestofProcess PLQSP804 FORMCHECKBOX QSPFolder 8)最终检验与测试程序ProcedureforFinalInspectionandTest PLQSP810 FORMCHECKBOX QSPFolder 4、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.No Applyornot 保存位置Location 1)产品的标签、语言规定ProductLabeling,Language PLQAD-CWI-XXX FORMCHECKBOX DMRFolder 2)标签Labeling FORMCHECKBOX DMRFolder 3)使用说明书Manual FORMCHECKBOX DMRFolder 4)包装作业指导书Instructionforpackage MEI-XXXX-XX FORMCHECKBOX DMRFolder 5)医疗产品包装标识、标签、说明书控制工作指示Packing、Labeling、Manualcontrolinstruction PLQAD-CWI-086 FORMCHECKBOX CWIFolder 5、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.No Applyornot 保存位置Location 1)货仓物料储存仓位指示StoremanagementInstruction PLSTO-CWI-005 FORMCHECKBOX CWIFolder 2)搬运、贮存、包装、防备和交付程序ProcedureforHandling,Storage,Packaging,PreservationandDelivery PLQSP707 FORMCHECKBOX CWIFolder