EN 12460:1998
Current
The latest, up-to-date edition.
Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
18-02-1998
Foreword
1 Scope
2 Definitions
3 Procedure for selection of equipment
4 Verification of performance in practice
5 Control
6 Documentation
Annex A (informative) Examples for a risk analysis
Annex B (informative) Bibliography
This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.
| Committee |
CEN/TC 233
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NBN EN 12460 : 1998 | Identical |
| NEN EN 12460 : 1998 | Identical |
| I.S. EN 12460:1998 | Identical |
| NS EN 12460 : 1ED 1999 | Identical |
| BS EN 12460:1998 | Identical |
| NF EN 12460 : 1998 | Identical |
| PN EN 12460 : 2002 | Identical |
| DIN EN 12460:1998-04 | Identical |
| UNE-EN 12460:1998 | Identical |
| BS EN 13311-5:2001 | Biotechnology. Performance criteria for vessels Kill tanks |
| BS EN 13091:2000 | Biotechnology. Performance criteria for filter elements and filtration assemblies |
| EN 13311-4:2001 | Biotechnology - Performance criteria for vessels - Part 4: Bioreactors |
| EN 13311-1:2001 | Biotechnology - Performance criteria for vessels - Part 1: General performance criteria |
| EN 12884:1999 | Biotechnology - Performance criteria for centrifuges |
| 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 |
| BS EN 12884:1999 | Biotechnology. Performance criteria for centrifuges |
| BS EN 12885:1999 | Biotechnology. Performance criteria for cell disrupters |
| BS EN 13311-1:2001 | Biotechnology. Performance criteria for vessels General performance criteria |
| BS EN 13311-4:2001 | Biotechnology. Performance criteria for vessels Bioreactors |
| BS EN 13095:2000 | Biotechnology. Performance criteria for off-gas systems |
| BS EN 12690:1999 | Biotechnology. Performance criteria for shaft seals |
| EN 13092:1999 | Biotechnology - Equipment - Guidance on sampling and inoculation procedures |
| EN 13095:1999 | Biotechnology - Performance criteria for off-gas systems |
| EN 12297:1998 | Biotechnology - Equipment - Guidance on testing procedures for sterilizability |
| EN 12298:1998 | Biotechnology - Equipment - Guidance on testing procedures for leaktightness |
| EN 1050 : 1996 | SAFETY OF MACHINERY - PRINCIPLES FOR RISK ASSESSMENT |
| EN 1620:1996 | Biotechnology - Large-scale process and production - Plant building according to the degree of hazard |
| EN 1619:1996 | Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures |
| EN 12296:1998 | Biotechnology - Equipment - Guidance on testing procedures for cleanability |