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  • EN 12298:1998

    Current The latest, up-to-date edition.

    Biotechnology - Equipment - Guidance on testing procedures for leaktightness

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    Published date:  18-03-1998

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    1 Scope
    2 Definitions
    3 Testing
    4 Documentation
    Annex A (informative) Guidance on selection of test
            methods
    Annex B (informative) Testing procedures for leak rate
    Annex C (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard gives guidance on general testing procedures to assess the leaktightness for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the leaktightness of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

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

    Committee CEN/TC 233
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    BS EN 13311-5:2001 Biotechnology. Performance criteria for vessels Kill tanks
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    BS EN 13091:2000 Biotechnology. Performance criteria for filter elements and filtration assemblies
    EN 13312-4:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes
    EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    EN 13311-1:2001 Biotechnology - Performance criteria for vessels - Part 1: General performance criteria
    EN 12884:1999 Biotechnology - Performance criteria for centrifuges
    EN 13312-2:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 2: Couplings
    EN 13311-2:2001 Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices
    EN 12462:1998 Biotechnology - Performance criteria for pumps
    EN 13311-5:2001 Biotechnology - Performance criteria for vessels - Part 5: Kill tanks
    EN 13312-1:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria
    EN 12690:1999 Biotechnology - Performance criteria for shaft seals
    EN 13091:1999 Biotechnology - Performance criteria for filter elements and filtration assemblies
    BS EN 12460:1998 Biotechnology. Large-scale process and production. Guidance on equipment selection and installation in accordance with the biological risk
    BS EN 12884:1999 Biotechnology. Performance criteria for centrifuges
    BS EN 12885:1999 Biotechnology. Performance criteria for cell disrupters
    01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
    BS EN 13311-1:2001 Biotechnology. Performance criteria for vessels General performance criteria
    BS EN 13312-4:2001 Biotechnology. Performance criteria for piping and instrumentation Tubes and pipes
    BS EN 13311-4:2001 Biotechnology. Performance criteria for vessels Bioreactors
    BS EN 12462:1998 Biotechnology. Performance criteria for pumps
    BS EN 13311-2:2001 Biotechnology. Performance criteria for vessels Pressure protection devices
    BS EN 13312-5:2001 Biotechnology. Performance criteria for piping and instrumentation Valves
    BS EN 13312-2:2001 Biotechnology. Performance criteria for piping and instrumentation Couplings
    BS EN 13312-6:2001 Biotechnology. Performance criteria for piping and instrumentation Equipment probes
    BS EN 13311-3:2001 Biotechnology. Performance criteria for vessels Glass pressure vessels
    BS EN 13311-6:2001 Biotechnology. Performance criteria for vessels Chromatography columns
    BS EN 13095:2000 Biotechnology. Performance criteria for off-gas systems
    BS EN 12469:2000 Biotechnology. Performance criteria for microbiological safety cabinets
    BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    BS EN 12690:1999 Biotechnology. Performance criteria for shaft seals
    EN 12460:1998 Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
    EN 13312-6:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 6: Equipment probes
    EN 13095:1999 Biotechnology - Performance criteria for off-gas systems
    EN 13311-3:2001 Biotechnology - Performance criteria for vessels - Part 3: Glass pressure vessels
    EN 13312-5:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 5: Valves
    DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

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

    EN 1093-1:2008 Safety of machinery - Evaluation of the emission of airborne hazardous substances - Part 1: Selection of test methods
    EN 1093-3:2006+A1:2008 Safety of machinery - Evaluation of the emission of airborne hazardous substances - Part 3: Test bench method for the measurement of the emission rate of a given pollutant
    BS 3636:1963 Methods for proving the gas tightness of vacuum or pressurized plant
    EN 626-2:1996+A1:2008 Safety of machinery - Reduction of risk to health from hazardous substances emitted by machinery - Part 2: Methodology leading to verification procedures
    EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
    EN 626-1:1994+A1:2008 Safety of machinery - Reduction of risks to health from hazardous substances emitted by machinery - Part 1: Principles and specifications for machinery manufacturers
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