7 it is the sum total of all validation data that provides the necessary level of assurance for aseptically produced products 7所有验证数据提供了无菌产品生产所需达到的保证水平。
2.
Sterilization of medical devices - requirements for medical devices to be designated " sterile " - requirements for aseptically processed medical devices 医疗器械的灭菌.拟被认定为无菌的医疗设备的要求.无菌处理的医疗设备的要求
3.
Sterilization of medical devices - requirements for medical devices to be designated sterile - part 2 : requirements for aseptically processed medical devices ; german version en 556 - 2 : 2003 医疗器械的消毒.对标有"消毒"字样的医疗器械的要求
4.
" sterilization of medical devices - requirements for medical devices to be designated " sterile " - part 2 : requirements for aseptically processed medical devices " 医疗器械的消毒.对标有"消毒"字样的医疗器械的要求.第2部分:经无菌处理的医疗器械的要求
5.
5 the following chapter illustrates the test procedures for the various simulation tests for aseptically produced solutions , lyophiles , suspensions , ointments and powders and summarizes the considerations to be made 5以下章节描述了不同的模拟检测所用的检测方法和需要考虑的事项，如：无菌溶液，冻干粉，乳液，膏剂和粉剂。
