目 录1.目的...................................................................................................................................................... 22.范围...................................................................................................................................................... 23.职责...................................................................................................................................................... 24.定义与缩略语.......................................................................................................................................34.1 定义34.2 缩略语 35.参考文件...............................................................................................................................................36.概述...................................................................................................................................................... 37. 确认前准备...............................................................................................................................................37.1 人员培训确认37.2 文件的确认37.3 仪器仪表的确认37.4 培育基及试液确认38.确认的实施...........................................................................................................................................38.1 挑战菌确认 38.2 接触碟回收率确认38.3 擦拭有效性确认38.4 挑战性确认38.5 偏差管理38.6 变更控制39 确认总结.................................................................................................................................................... 310 变更历史.................................................................................................................................................. 311 附件清单...........................................................................................................................................................3文件名称消毒剂消毒效果验证方案设计确认方案文件...
