医疗器械技术文档清单.docxVIP

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 Apply Doc.No or not 保存位置 Location 　1)设计输入 Product Design Input PLPDI-XXXX-XX 　DHF Folder 　2)产品规格 Product Design Specification PLPDS-XXXX-XX 　DHF Folder 　3)零件规格 Component Evaluation Report XXXX-XXXXX 　DMR Folder 　4)塑胶件配方表 Formulation Control Report XXXX-XXX 　DMR Folder 5)图纸 Drawing XXXX-XXXXX DMR Folder 6)软件 Software 　7)使用该产品的适用标准 Appropriate Standard XXXXXXXXX Standard Folder 　 　 　 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 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 Apply Doc.No or not 保存位置 Location 　1)主要生产设备清单 The Appropriate Equipment List PLPIE-MLT-XXX 　DMR Folder 　2)产品作业流程 Produce Flow Chart PLC-XXXX-XX 　DMR Folder 3)排拉表 Produce Line layout PLL-XXXX-XX DMR Folder 　3)产品工艺文件 Manual Engineering Instructions MEI-XXXX-XXX 　DMR Folder 　4)产品的批号规定 Lot No Define Instruction EI-XXXX 　DMR Folder 　5)产品的灭菌方法和确认 Sterilization means and validation 　DMR Folder 　6)灭菌验证 Sterilization verification 　DMR Folder 　7)培训程序 Procedure for Training PLQSP601 　QSP Folder 　8)一万级无尘房监控指引 Clean room monitor instruction PLPIE-CWI-008 　CWI Folder 　9)设备维修与保养程序 Procedure for Maintenance and Repair of Devices PLQSP602 　QSP Folder 　10)制程控制程序 Procedure for Process Control PLQSP704 　QSP Folder 　13)无尘房日常维护保养工作指示 Instruction for Clean Room Maintain PLPIE-CWI-039 　CWI Folder 　14)医疗产品转拉清拉工作指示 PLQAD-CWI-087 　CWI Folder 　　　 　 　 　 Instruction for line change 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 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 Apply Doc.No or not 保存位置 Location 　1)品质保证计划 Quality Assurance Plan PLQAP-XXXX-XX 　DMR Folder 　2)产品质量控制工作指示 Qual