EN ISO 13408-6:2011
Withdrawn
Withdrawn
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Amended by
Published date
06-29-2011
Publisher
Withdrawn date
12-31-2011
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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.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| I.S. EN ISO 13408-6:2011 | Equivalent |
| DIN EN ISO 13408-6:2011-09 | Equivalent |
| BS EN ISO 13408-6 : 2011 | Equivalent |
| UNE-EN ISO 13408-6:2011 | Identical |
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