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UNE-EN ISO 13408-6:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Available format(s)

Hardcopy , PDF

Superseded date

16-02-2022

Published date

28-12-2011

Committee
CTN 111
DevelopmentNote
Supersedes UNE EN 13824. (01/2012)
DocumentType
Standard
Pages
28
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 13408-6:2005 Identical
EN ISO 13408-6:2011/A1:2013 Identical
EN ISO 13408-6:2011 Identical

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
IEST RP CC006.2 : 1997 TESTING CLEANROOMS
ISO 10648-1:1997 Containment enclosures — Part 1: Design principles
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015 Quality management systems — Requirements
ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place

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