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Norm
ÖNORM EN ISO 13408-6
Issue date: 2013 12 01
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (consolidated version)
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers
guidance on qualification, bio-decontamination, validation,...
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Withdrawn
: 2021 10 15
Publisher:
Austrian Standards International
Format:
Digital | 28 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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 isolator systems used for
aseptic processing of health care products.
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.
ÖNORM EN ISO 13408-6
2021 10 15
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
Norm
ÖNORM EN ISO 13408-6
2013 12 01
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013...
Norm
↖
ÖNORM EN ISO 13408-6
2011 09 15
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Norm
ÖNORM EN 13824
2005 02 01
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
Norm
Norm
ISO 13408-4:2005
Issue date :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Issue date :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Norm
ISO/IEC 90003:2004
Issue date :
2004 02 11
Software engineering — Guidelines for the application of ISO 9001:2000 to computer software
Final Draft
ISO/IEC FDIS 90003
Issue date :
2014 05 28
Software engineering — Guidelines for the application of ISO 9001:2008 to computer software
Norm
ISO 13408-1:2008
Issue date :
2008 06 10
Aseptic processing of health care products — Part 1: General requirements
Norm
ISO 13408-4:2005
Issue date :
2005 10 28
Aseptic processing of health care products — Part 4: Clean-in-place technologies
Norm
ISO 13408-5:2006
Issue date :
2006 11 15
Aseptic processing of health care products — Part 5: Sterilization in place
Norm
ISO 14644-7:2004
Issue date :
2004 10 07
Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Norm
ISO/IEC 90003:2014
Issue date :
2014 12 09
Software engineering — Guidelines for the application of ISO 9001:2008 to computer software
Norm
ÖNORM EN ISO 13408-6
Issue date :
2021 10 15
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
Norm
ISO 13408-6:2005
Issue date :
2005 06 20
Aseptic processing of health care products — Part 6: Isolator systems