AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 : R201300現行
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
出版：Association for the Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 : R201300
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標準頁數：0
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.
等同采用的國際標準
ISO 13408-6 : 2005(R2014) - Identical
