This standard was last reviewed and confirmed in 2014. Therefore this version remains current.
Abstract Preview
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.
General information
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Status : PublishedPublication date : 2005-06
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Edition : 1Number of pages : 17
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- ICS :
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Sterilization and disinfection in general
Buy this standard
| Format | Language | |
|---|---|---|
| Paper |
- CHF88
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Now under review
ISO 13408-6:2005 -
Corrigenda/Amendments
ISO 13408-6:2005/Amd 1:2013
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Will be replaced by
ISO/DIS 13408-6
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