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Aseptic Processing Of Health Care Products - Part 6: Isolator Systems
出版:Standardiserings-Kommissionen I Sverige

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基本信息
標(biāo)準(zhǔn)編號(hào): SS EN ISO 13408-6 Ed. 1 (2011)
發(fā)布時(shí)間:2011/7/12 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Standardiserings-Kommissionen I Sverige
標(biāo)準(zhǔn)頁(yè)數(shù):36
標(biāo)準(zhǔn)簡(jiǎn)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.
標(biāo)準(zhǔn)備注
Supersedes SS EN 13824. (08/2011)
本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)