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  • BS EN ISO 14644-7:2004

    Current The latest, up-to-date edition.

    Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  14-10-2004

    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 Requirements
    5 Design and construction
    6 Access devices
      6.1 Use
      6.2 Manual operation
      6.3 Robotic handling
    7 Transfer devices
      7.1 Use
      7.2 Selection
      7.3 Fail-safe design
    8 Siting and installing
    9 Testing and approval
      9.1 General
      9.2 Glove breach test
      9.3 Operating differential pressure
      9.4 Leak testing
      9.5 Periodic testing
    Annex A (informative) Separation continuum concept
    Annex B (informative) Air-handling systems and gas systems
    Annex C (informative) Access devices
    Annex D (informative) Examples of transfer devices
    Annex E (informative) Leak testing
    Annex F (informative) Parjo leak test method
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.

    Scope - (Show below) - (Hide below)

    This part of ISO14644 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO14644-4 and 14644-5.

    The application of this part of ISO14644 takes into account the following limitations.

    • User requirements are as agreed by customer and supplier.

    • Application-specific requirements are not addressed.

    • Specific processes to be accommodated in the separative-device installation are not specified.

    • Fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.

    This part of ISO14644 is not applicable to full-suits.

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

    Committee LBI/30
    Development Note Supersedes 01/121101 DC (11/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    12/30240811 DC : 0 BS 8568 - CLEANROOM ENERGY - CODE OF PRACTICE FOR IMPROVING ENERGY EFFICIENCY IN CLEANROOMS AND CLEAN AIR DEVICES
    PD 6609:2007 Environmental cleanliness in enclosed spaces. Guide to in situ high efficiency filter leak testing
    BS 8568:2013 Cleanroom energy. Code of practice for improving energy efficiency in cleanrooms and clean air devices

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

    EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
    ISO 10648-1:1997 Containment enclosures — Part 1: Design principles
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    EN 12307:1997 Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    BS 3636:1963 Methods for proving the gas tightness of vacuum or pressurized plant
    NFC 01 371 : 85 AMD 1 1999 ELECTROTECHNICAL VOCABULARY - CHAPTER 371: TELECONTROL
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ENV 1631 : 1996 CLEANROOM TECHNOLOGY - DESIGN, CONSTRUCTION AND OPERATION OF CLEANROOMS AND CLEAR AIR DEVICES
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    EN 12296:1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
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