ISO 13408-6:2005现行
Aseptic processing of health care products Part 6: Isolator systems
出版：International Organization for Standardization
专家解读视频
ISO 13408-6:2005 specifies 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.ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
KS P ISO 13408-6:2010 - Identical
BS EN ISO 13408-6:2011 - Identical
AAMI ISO 13408-6:2005 (R2013) - Identical
NEN ISO 13408-6:2005 - Identical
