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EN 12469:2000

Current

Current

The latest, up-to-date edition.

Biotechnology - Performance criteria for microbiological safety cabinets

Published date

24-05-2000

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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

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)).

Committee
CEN/TC 332
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
BS EN 12469:2000 Identical
NF EN 12469 : 2000 Identical
I.S. EN 12469:2000 Identical
AS 2252.3-2011 Identical
GOST R EN 12469 : 2010 Identical
NS EN 12469 : 1ED 2000 Identical
NEN EN 12469 : 2000 Identical
SN EN 12469 : 2000 Identical
NBN EN 12469 : 2000 Identical
UNE-EN 12469:2001 Identical
PN EN 12469 : 2002 Identical
UNI EN 12469 : 2001 Identical
DIN EN 12469:2000-09 Identical

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
06/30152772 DC : 0 BS EN 15458 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
BS 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
PD 6632:1998 Biotechnology. Laboratories for research, development and analysis. Guidance on the selection of equipment needed for biotechnology laboratories according to the degree of hazard
I.S. EN 15458:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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
UNI EN 15457 : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
06/30152769 DC : 0 BS EN 15457 - PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
17/30365068 DC : 0 BS EN 14175-3 - FUME CUPBOARDS - PART 3: TYPE TEST METHODS
I.S. EN 15457:2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST FUNGI
EN 14175-3:2003 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 13312-3:2001 Biotechnology. Performance criteria for piping and instrumentation Sampling and inoculation devices
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) (includes Amendment :2013)
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
VDI 4258 Blatt 1:2017-03 Bioaerosols and biological agents - Generation of test bioaerosols - Basics and requirements for test bioaerosols
VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
VDI/VDE 3516 Blatt 2:1981-07 Process analytical equipment for fluids
VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
14/30292470 DC : 0 BS EN 15457 - 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
DIN EN 15457:2014-11 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against fungi
PREN 14175-2 : DRAFT 2001 FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
ISO 15190:2003 Medical laboratories Requirements for safety
BS EN 14175-3:2003 Fume cupboards Type test methods
DIN EN 15458:2014-11 Paints and varnishes - Laboratory method for testing the efficacy of film preservatives in a coating against algae
BS EN 15458:2014 Paints and varnishes. Laboratory method for testing the efficacy of film preservatives in a coating against algae
01/122562 DC : DRAFT JULY 2001 BS EN 14175-1 - FUME CUPBOARDS - PART 1: TERMS AND DEFINITIONS
UNI EN 15458 : 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
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
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
BS ISO 15190:2003 Medical laboratories. Requirements for safety
01/122563 DC : DRAFT JULY 2001 BS EN 14175-2 - FUME CUPBOARDS - PART 2: SAFETY AND PERFORMANCE REQUIREMENTS
CSA Z15190 : 2005 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
PREN 15458 : DRAFT 2014 PAINTS AND VARNISHES - LABORATORY METHOD FOR TESTING THE EFFICACY OF FILM PRESERVATIVES IN A COATING AGAINST ALGAE
BS EN 14175-1:2003 Fume cupboards Vocabulary
BS EN 14056:2003 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 14175-2:2003 Fume cupboards Safety and performance requirements
BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
EN 14056:2003 Laboratory furniture - Recommendations for design and installation
EN 14175-1:2003 Fume cupboards - Part 1: Vocabulary
EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
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
BIS IS 16122 : 2013 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS
I.S. EN 14175-3:2004 FUME CUPBOARDS - PART 3: TYPE TEST METHODS
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
CSA Z15190 : 2005 : R2015 MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY
BS EN ISO 7218 : 2007 MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - GENERAL REQUIREMENTS AND GUIDANCE FOR MICROBIOLOGICAL EXAMINATIONS
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

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
VDI 2083 Blatt 3:2005-07 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 (ISO 3744:2010)
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
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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