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ISO 13408-6:2005

Aseptic processing of health care products — Part 6: Isolator systems

Jun 20, 2005
95.99 Withdrawal of Standard   Apr 13, 2021

General information

95.99     Apr 13, 2021

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO 13408-6:2005
95.99 Withdrawal of Standard
Apr 13, 2021

CORRIGENDA / AMENDMENTS

WITHDRAWN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

REVISED BY

PUBLISHED
ISO 13408-6:2021