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  • EN 12469:2000

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    Biotechnology - Performance criteria for microbiological safety cabinets

    Available format(s): 

    Language(s): 

    Published date:  24-05-2000

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Hazards
    5 Performance classes
    7 Safety requirements
    8 Marking and packaging
    9 Documentation
    Annex A (informative) Guidance on materials, design
                          and manufacture
    Annex B (normative) Test method for leakage of carcass
                          for class I and II MSCs
    Annex C (normative) Test methods for the retention
                          efficiency at the front aperture
    Annex D (informative) Aerosol challenge test method for
                          installed HEPA filter system
                          leakage detection
    Annex E (normative) Test method for product
                          protection for class II MSCs
    Annex F (normative) Test method for cross contamination
                          protection for class II MSCs
    Annex G (informative) Method of measurement of volumetric
                          airflow rate
    Annex H (informative) Design of MSCs and airflow velocities
                          in MSCs
    Annex J (informative) Recommendations for decontamination,
                          cleaning and fumigation of MSCs and
                          filters
    Annex K (informative) Recommendations for routine maintenance
                          of MSCs
    Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard specifies basic requirements for microbiological safety cabinets (MSCs) with respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with microorganisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 610101-1, EN 292-1 and EN 292-2 (see Bibliography (1), (2) and (3)).

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

    Committee CEN/TC 332
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    PREN 14175-3 : DRAFT 2017 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    S.R. CWA 17253-2:2018 JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES
    BS EN 15458:2014 (published 2014-08) Paints and varnishes. Laboratory method for testing the efficacy of film preservatives in a coating against algae
    14/30292470 DC : 0 BS EN 15457 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    VDI 2083 Blatt 16.1:2010-08 CLEANROOM TECHNOLOGY - BARRIER SYSTEMS (ISOLATORS, MINI-ENVIRONMENTS, SEPARATIVE DEVICES) - EFFECTIVENESS AND CERTIFICATION
    14/30292467 DC : 0 BS EN 15458 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    UNE-EN 15458:2014 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against algae
    VDI 4258 Blatt 1:2017-03 Bioaerosols and biological agents - Generation of test bioaerosols - Basics and requirements for test bioaerosols
    DIN EN 15457 E : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    14/30302515 DC : 0 BS EN 14175-3 - FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    01/122562 DC : DRAFT JULY 2001 BS EN 14175-1 - FUME CUPBOARDS - PART 1: TERMS AND DEFINITIONS
    VDI/VDE 3516-2 : 1981 VALIDATION IN THE GXP AREA - SMALL MANUFACTURING AND TESTING DEVICES
    VDI 6300-1 : 2016 GENETIC ENGINEERING OPERATIONS IN GENETIC ENGINEERING FACILITIES - GUIDANCE ON SAFE OPERATION OF GENETIC ENGINEERING FACILITIES
    DIN EN 15458 E : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    UNI EN 15458 : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    VDI 2083-3 : 2005 CLEANROOM TECHNOLOGY - METROLOGY AND TEST METHODS
    DIN EN 15457:2014-11 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against fungi
    02/123878 DC : DRAFT OCT 2002 BS EN 14175-3 - FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    00/124544 DC : DRAFT NOV 2000 BS EN 14056 - LABORATORY FURNITURE - RECOMMENDATIONS FOR DESIGN AND INSTALLATION
    UNI EN 15457 : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    DIN EN 14175-3:2004-03 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    PREN 14175-1 : DRAFT 2001 FUME CUPBOARDS - PART 1: TERMS AND DEFINITIONS
    06/30152769 DC : 0 BS EN 15457 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    BS EN 15457:2014 (published 2014-08) Paints and varnishes. Laboratory method for testing the efficacy of film preservatives in a coating against fungi
    BS ISO 15190:2003 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    17/30365068 DC : 0 BS EN 14175-3 - FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    CSA Z15190 : 2005 : R2015 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    01/122563 DC : DRAFT JULY 2001 BS EN 14175-2 - FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
    I.S. EN 15457:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    PREN 15457 : DRAFT 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    CSA Z15190 : 2005 : R2010 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    CSA Z15190 : 2005 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
    EN 14175-3 : 2003 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    BS EN 14175-3:2003 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    BS PD6632(1998) : 1998 BIOTECHNOLOGY - LABORATORIES FOR RESEARCH, DEVELOPMENT AND ANALYSIS - GUIDANCE ON THE SELECTION OF EQUIPMENT NEEDED FOR BIOTECHNOLOGY LABORATORIES ACCORDING TO THE DEGREE OF HAZARD
    PREN 15458 : DRAFT 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    I.S. EN 15458:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    BIS IS 16122 : 2013 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS
    06/30152772 DC : 0 BS EN 15458 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
    PREN 14175-2 : DRAFT 2001 FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
    ISO 15190:2003 Medical laboratories Requirements for safety
    DIN EN 15458:2014-11 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against algae
    I.S. EN 14175-3:2004 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
    DIN EN 12128:1998-05 BIOTECHNOLOGY - LABORATORIES FOR RESEARCH, DEVELOPMENT AND ANALYSIS - CONTAINMENT LEVELS OF MICROBIOLOGY LABORATORIES, AREAS OF RISK, LOCALITIES AND PHYSICAL SAFETY REQUIREMENTS
    BS EN 14175-1 : 2003 FUME CUPBOARDS - PART 1: VOCABULARY
    BS EN 14056:2003 (published 2003-04) Laboratory furniture. Recommendations for design and installation
    ISO 7218:2007 Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations
    BS EN 13312-3 : 2001 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR PIPING AND INSTRUMENTATION - PART 3: SAMPLING AND INOCULATION DEVICES
    ISO 14644-7:2004 Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    BS EN ISO 7218 : 2007 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS
    BS EN 14175-2 : 2003 FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
    BS EN ISO 14644-7 : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE DEVICES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS AND MINI-ENVIRONMENTS)
    DIN EN ISO 7218:2014-09 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS (ISO 7218:2007 + AMD 1:2013, CORRECTED VERSION 2014-04-15)
    I.S. EN ISO 7218:2007 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS (ISO 7218:2007)
    DIN EN 14175-2:2003-08 FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
    EN 12128:1998 Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements
    EN 13312-3 : 2001 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR PIPING AND INSTRUMENTATION - PART 3: SAMPLING AND INOCULATION DEVICES
    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
    EN 14056 : 2003 LABORATORY FURNITURE - RECOMMENDATIONS FOR DESIGN AND INSTALLATION
    EN 14175-1 : 2003 FUME CUPBOARDS - PART 1: VOCABULARY
    EN 14175-2 : 2003 FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
    EN ISO 7218 : 2007 COR 2014 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS (ISO 7218:2007/AMD 1:2013, CORRECTED VERSION 2014-04-15)
    EN 15457:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
    EN 15458:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE

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

    IEST RP CC006.2 : 1997 TESTING CLEANROOMS
    ISO 5349:1986 Mechanical vibration — Guidelines for the measurement and the assessment of human exposure to hand-transmitted vibration
    EN 12297:1998 Biotechnology - Equipment - Guidance on testing procedures for sterilizability
    ISO 4871:1996 Acoustics Declaration and verification of noise emission values of machinery and equipment
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
    BS 848-1(1997) : 1997 FANS FOR GENERAL PURPOSES - PERFORMANCE TESTING USING STANDARDIZED AIRWAYS
    VDI 2083-3 : 2005 CLEANROOM TECHNOLOGY - METROLOGY AND TEST METHODS
    EN 292-1 : 1991 SAFETY OF MACHINERY - BASIC CONCEPTS, GENERAL PRINCIPLES FOR DESIGN - BASIC TERMINOLOGY, METHODOLOGY
    EN 12741:1999 Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations
    EN ISO 3744:2010 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS AND SOUND ENERGY LEVELS OF NOISE SOURCES USING SOUND PRESSURE - ENGINEERING METHODS FOR AN ESSENTIALLY FREE FIELD OVER A REFLECTING PLANE
    EN 12296:1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability
    EN 13091:1999 Biotechnology - Performance criteria for filter elements and filtration assemblies
    EN 292-2 : 91 AMD 1 95 SAFETY OF MACHINERY - BASIC CONCEPTS, GENERAL PRINCIPLES FOR DESIGN - TECHNICAL PRINCIPLES AND SPECIFICATION
    EN 1822-1 : 2009 HIGH EFFICIENCY AIR FILTERS (EPA, HEPA AND ULPA) - PART 1: CLASSIFICATION, PERFORMANCE TESTING, MARKING
    EN 61010-1:2010 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS (IEC 61010-1:2010)
    ISO 11201:2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections
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