EN 12298:1998
Current
Current
The latest, up-to-date edition.
Biotechnology - Equipment - Guidance on testing procedures for leaktightness
Published date
18-03-1998
Publisher
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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) |
| 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) |
| 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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