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    I.S. EN ISO 13408-6:2011

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  30-11-2021

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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)

    Development Note Supersedes I.S. EN 13824. (07/2011)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    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/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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