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  • BS EN ISO 13408-6 : 2011

    Current The latest, up-to-date edition.

    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality system elements
    5 Design of isolator systems
    6 Facility requirements
    7 User requirements
    8 Validation
    9 Routine monitoring and control
    10 Personnel training
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 90/385/EEC on Active Implantable
             Medical Devices
    Annex ZB (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC on Medical Devices
    Annex ZC (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 98/79/EC on in vitro diagnostic
             medical devices

    Abstract - (Show below) - (Hide below)

    Gives 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.

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

    Committee CH/198
    Development Note Together with BS EN ISO 13408-1, 2, 3, 4 and 5, it supersedes BS EN 13824. (10/2011) 2011 Edition Re-Issued in June 2013 & incorporates AMD 1 2013. Supersedes 12/30250823 DC. (06/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    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/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    ISO 10648-1:1997 Containment enclosures — Part 1: Design principles
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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 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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