医疗器械技术文档清单.doc

医疗器械技术文档清单（DMR LIST）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Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications技术文件Device master record文件编号Doc.NoApply or not保存位置Location1)设计输入Product Design InputPLPDI-XXXX-XXDHF Folder2)产品规格Product Design SpecificationPLPDS-XXXX-XXDHF Folder3)零件规格Component Evaluation ReportXXXX-XXXXXDMR Folder4)塑胶件配方表Formulation Control ReportXXXX-XXXDMR Folder5)图纸DrawingXXXX-XXXXXDMR Folder6)软件Software7)使用该产品的适用标准Appropriate StandardXXXXXXXXXStandard Folder2、 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Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications技术文件Device master record文件编号Doc.NoApply or not保存位置Location1)主要生产设备清单The Appropriate Equipment ListPLPIE-MLT-XXXDMR Folder2)产品作业流程Produce Flow ChartPLC-XXXX-XXDMR Folder3)排拉表Produce Line layoutPLL-XXXX-XX DMR Folder3)产品工艺文件Manual Engineering InstructionsMEI-XXXX-XXXDMR Folder4)产品的批号规定Lot No Define InstructionEI-XXXXDMR Folder5)产品的灭菌方法和确认Sterilization means and validationDMR Folder6)灭菌验证Sterilization verification DMR Folder7)培训程序Procedure for TrainingPLQSP601QSP Folder8)一万级无尘房监控指引Clean room monitor instructionPLPIE-CWI-008CWI Folder9)设备维修与保养程序Procedure for Maintenance and Repair of DevicesPLQSP602QSP Folder10)制程控制程序Procedure for Process ControlPLQSP704QSP Folder13)无尘房日常维护保养工作指示Instruction for Clean Room Maintain PLPIE-CWI-039CWI Folder14)医疗产品转拉清拉工作指示Instruction for line change PLQAD-CWI-087CWI Folder3、 品质保证程序及规格，包括允收基准及所使用的品保设备Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used技术文件Device master record文件编号Doc.NoApply or not保存位置Location1)品质保证计划Quality Assurance PlanPLQAP-XXXX-XXDMR Folder2)产品质量控制工作指示Quality Control InstructionQCI-XXXX-XXDMR Folder3)产品测试计划Product Test PlanPLPTP-XXXX-XXDMR Folder4)接受标准与检验方法PLQAD-XXXX-XXDMR Folder5)计量校准控制程序Procedure for Management and CalibrationPLQSP708QSP Folder6)来料检验和测试程序Procedure for Inspection and Test of Incoming MaterialsPLQSP803QSP Folder7)制程检验与测试程序Procedure for Inspection and Test of ProcessPLQSP804QSP Folder8)最终检验与测试程序Procedure for Final Inspection and TestPLQSP810QSP Folder4、 包装及标签规格，包括所使用的方法及程序Packaging and labeling specifications, including methods and processes used技术文件Device master record文件编号Doc.NoApply or not保存位置Location1)产品的标签、语言规定Product Labeling, LanguagePLQAD-CWI-XXXDMR Folder2)标签LabelingDMR Folder3)使用说明书ManualDMR Folder4)包装作业指导书Instruction for packageMEI-XXXX-XXDMR Folder5)医疗产品包装标识、标签、说明书控制工作指示Packing、Labeling、Manual control instructionPLQAD-CWI-086CWI Folder5、 安装、保养、及服务程序和方法Installation, maintenance, and servicing procedures and methods技术文件Device master record文件编号Doc.NoApply or not保存位置Location1）货仓物料储存仓位指示Store ma