AAMI ISO 13408-6:2005現行
Aseptic Processing Of Health Care Products - Part 6: Isolator Systems
出版：Association for Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： AAMI ISO 13408-6:2005
標準類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標準頁數：44
標準簡介
Describes the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
本標準替代的舊標準
等同采用的國際標準
ISO 13408-6 : 2005(R2014) - Identical
