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SRPS ISO 13408-6:2010

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

Apr 26, 2010
95.99   Withdrawal of Standard   Apr 30, 2014

General information

95.99     Apr 30, 2014

ISS

Z076

International Standard

11.080.01  

English  

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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WITHDRAWN
SRPS ISO 13408-6:2010
95.99 Withdrawal of Standard
Apr 30, 2014

REVISED BY

WITHDRAWN
SRPS EN ISO 13408-6:2014

Related project

Adopted from ISO 13408-6:2005