用户需求文件姓名/职务签名日期作者审核批准目录1.介绍....................................................................................................................................................................42.目的和范围........................................................................................................................................................43.缩写列表............................................................................................................................................................44.设备标准............................................................................................................................................................55.用户需求............................................................................................................................................................55.1热风循环烘箱URS·生产工艺要求....................................................................................................65.2热风循环烘箱URS·厂房设施及公用系统要求................................................................................65.3热风循环烘箱URS·设备要求............................................................................................................75.4热风循环烘箱URS·性能要求..........................................................................................................105.5热风循环烘箱URS·QA要求............................................................................................................125.6热风循环烘箱URS·RAM（维修服务）及保修要求.....................................................................125.7热风循环烘箱URS·清洗消毒要求..................................................................................................135.8热风循环烘箱URS·EHS要求..........................................................................................................145.9热风循环烘箱URS·FAT＆SAT要求................................................................................................155.10热风循环烘箱URS·包装运输验货要求.......................................................................................165.11热风循环烘箱URS·文件资料要求...............................................................................................165.12热风循环烘箱URS·备品零件要求...............................................................................................175.13热风循环烘箱URS·安装调试要求...............................................................................................175.14热风循环烘箱URS·培训要求......................................................................................................185.15热风循环烘箱URS·时间要求......................................................................................................195.16热风循环烘箱URS·其他要求......................................................................................................195.17热风循环烘箱URS·附机要求......................................................................................................20用户需求文件设备名称：热风循环烘箱页码：2/141.介绍抗肿瘤药制剂车间，现采购新的热风循环烘箱，本文件是为该设备而编写的用户需求标准。2.目的和范围目的：本文件旨在从项目和系统的角度阐述用户的需求，主要包括相关法规符合度和用户的...
