医疗器械技术文档清单.doc

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1、医疗器械技术文档清单（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.NoApplyornot保存位置Location　1)设计输入ProductDesignInputPLPDI-XXXX-XX　DHFFolder　2)产品规格ProductDesig

2、nSpecificationPLPDS-XXXX-XX　DHFFolder　3)零件规格ComponentEvaluationReportXXXX-XXXXX　DMRFolder　4)塑胶件配方表FormulationControlReportXXXX-XXX　DMRFolder5)图纸DrawingXXXX-XXXXXDMRFolder6)软件Software　7)使用该产品的适用标准AppropriateStandardXXXXXXXXXStandardFolder　　　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Productionprocesss

3、pecificationsincludingtheappropriateequipmentspecifications,productionmethods,productionprocedures,andproductionenvironmentspecifications技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location　1)主要生产设备清单TheAppropriateEquipmentListPLPIE-MLT-XXX　DMRFolder　2)产品作业流程ProduceFlowChartPLC-XXXX-XX　DMR

4、Folder3)排拉表ProduceLinelayoutPLL-XXXX-XXDMRFolder　3)产品工艺文件ManualEngineeringInstructionsMEI-XXXX-XXX　DMRFolder　4)产品的批号规定LotNoDefineInstructionEI-XXXX　DMRFolder　5)产品的灭菌方法和确认Sterilizationmeansandvalidation　DMRFolder　6)灭菌验证Sterilizationverification　DMRFolder　7)培训程序ProcedureforTrainingPLQSP601　QSP

5、Folder　8)一万级无尘房监控指引CleanroommonitorinstructionPLPIE-CWI-008　CWIFolder　9)设备维修与保养程序ProcedureforMaintenanceandRepairofDevicesPLQSP602　QSPFolder　10)制程控制程序ProcedureforProcessControlPLQSP704　QSPFolder　13)无尘房日常维护保养工作指示InstructionforCleanRoomMaintainPLPIE-CWI-039　CWIFolder　14)医疗产品转拉清拉工作指示Instruction

6、forlinechangePLQAD-CWI-087　CWIFolder　　　1、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Location　1)品质保证计划QualityAssurancePlanPLQAP-XXXX-XX　DMRFolder　2)产品质量控制工作

7、指示QualityControlInstructionQCI-XXXX-XX　DMRFolder　3)产品测试计划ProductTestPlanPLPTP-XXXX-XX　DMRFolder　4)接受标准与检验方法PLQAD-XXXX-XX　DMRFolder　5)计量校准控制程序ProcedureforManagementandCalibrationPLQSP708　QSPFolder　6)来料检验和测试程序ProcedureforInspectionandTestofIncomingMa