医疗器械技术 清单

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 文件编号 技术文件Device master record Doc.No Apply 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 文件编号 技术文件Device master record 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 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 MEI-XXXX-XXX DMR Folder Instructions 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 DMR Folder means and validation 6)灭菌验证Sterilization DMR Folder verification 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 PLQSP704 QSP Folder Control 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Instruction for line change PLQAD-CWI-087 CWI Folder 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 文件编号 技术文件Device master record Doc.No Apply 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Quality Control Instruction QCI-XXXX-XX DMR Folder 3)产品测试计划Product Test Plan PLPTP-XXXX-XX DMR Folder 4)接受标准与检验方法 PLQAD-XXXX-XX DMR Folder 5)计量校准控制程序Procedure for Management and Calibration PLQSP708 QSP Folder 6)来料检验和测试程序Procedure for Inspection and Test of Incoming Materials PLQSP803 QSP Folder 7)制程检验与测试程序Procedure for Inspection and Test of Process PLQSP804 QSP Folder 8)最终检验与测试程序Procedure for Final Inspection and Test PLQSP810 QSP Folder 4、 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 文件编号 技术文件Device master record Doc.No Apply 保存位置Location or not 1)产品的标签、语言规定Product Labeling, Language PLQAD-CWI-XXX DMR Folder 2)标签Labeling DMR Folder 3)使用说明书Manual DMR Folder 4)包装作业指导书Instruction for package MEI-XXXX-XX DMR Folder 5)医疗产品包装标识、标签、说明书控制PLQAD-CWI-086 工作指示Packing、Labeling、Manual control instruction CWI Folder 5、 安装、保养、及服务程序和方法Installation, maintenance, and servicing procedures and methods 文件编号 技术文件Device master record Doc.No Apply 保存位置Location or not 1）货仓物料储存仓位指示Store PLSTO-CWI-005 CWI Folder management Instruction 2）搬运、贮存、包装、防备和交付程序PLQSP707 Procedure for Handling, Storage, CWI Folder Packaging, Preservation and Delivery