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.
DS/EN ISO 13408-6-2011由丹麦标准化协会 DK-DS 发布于 2011-09-04,并于 2011-09-04 实施。
DS/EN ISO 13408-6-2011在国际标准分类中归属于: 11.080.01 消毒和灭菌综合。
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