DIN EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
active, Most Current
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| Organization: | DIN |
| Publication Date: | 1 July 2013 |
| Status: | active |
| Page Count: | 28 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This part of ISO 13408 specifies the requirements for isolator
systems used for aseptic processing and offers guidance on
qualification, bio-decontamination,
This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
This part of ISO 13408 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.
Document History
November 1, 2021
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
A description is not available for this item.
May 1, 2019
Aseptic processing of health care products - Part 6: Isolator systems (ISO/DIS 13408-6:2019); German and English version prEN ISO 13408-6:2019
A description is not available for this item.
DIN EN ISO 13408-6
July 1, 2013
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of...
September 1, 2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
A description is not available for this item.