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ISO 13408-6:2005

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

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Kehtetu alates 13.04.2021
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Staatus
Kuupäev
Tüüp
Nimetus
13.04.2021
Põhitekst
12.03.2013
Muudatus
20.06.2005
Põhitekst
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.
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