• UNE-EN ISO 13408-6:2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  16-02-2022

    Language(s): 

    Published date:  28-12-2011

    Publisher:  Asociacion Espanola de Normalizacion

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    General Product Information - (Show below) - (Hide below)

    Committee CTN 111
    Development Note Supersedes UNE EN 13824. (01/2012)
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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