医疗器械技术文档清单.doc

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