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EN 12298:1998

Current
Current

The latest, up-to-date edition.

Biotechnology - Equipment - Guidance on testing procedures for leaktightness
Published date

18-03-1998

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

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.

Committee
CEN/TC 233
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
UNI EN 12298 : 2001 Identical
I.S. EN 12298:1998 Identical
UNE-EN 12298:1998 Identical
DIN EN 12298:1998-05 Identical
BS EN 12298:1998 Identical
NEN EN 12298 : 1998 Identical
NF EN 1221998 : 1998 Identical
NS EN 12298 : 1ED 1999 Identical
NBN EN 12298 : 1998 Identical
SN EN 12298 : 1998 Identical
PN EN 12298 : 2002 Identical

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

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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