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ISO 13408-6:2005現(xiàn)行

Aseptic processing of health care products Part 6: Isolator systems

出版：International Organization for Standardization

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基本信息
標(biāo)準(zhǔn)編號(hào)： ISO 13408-6:2005
發(fā)布時(shí)間：2005/6/20 0:00:00
標(biāo)準(zhǔn)類(lèi)別：Standard
出版單位：International Organization for Standardization
標(biāo)準(zhǔn)頁(yè)數(shù)：17
標(biāo)準(zhǔn)簡(jiǎn)介

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.

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

ISO/DIS 13408-6

等同采用的國(guó)際標(biāo)準(zhǔn)

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

本標(biāo)準(zhǔn)修訂后的版本

ISO 13408-6:2005/Amd 1:2013 -