EN 12297:1998
Current
The latest, up-to-date edition.
Biotechnology - Equipment - Guidance on testing procedures for sterilizability
18-03-1998
Foreword
1 Scope
2 Definitions
3 Testing
4 Documentation
Annex A (informative) Guidance on selection of
sterilizability testing
Annex B (informative) Information on test methods for
sterilizability
Annex C (informative) Bibliography
This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability 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 |
| BS EN 12297:1998 | Identical |
| I.S. EN 12297:1998 | Identical |
| UNI EN 12297 : 2000 | Identical |
| UNE-EN 12297:1998 | Identical |
| PN EN 12297 : 2002 | Identical |
| NEN EN 12297 : 1998 | Identical |
| NS EN 12297 : 1ED 1999 | Identical |
| NF EN 12297 : 1998 | Identical |
| DIN EN 12297:1998-05 | Identical |
| SN EN 12297 : 1998 | Identical |
| NBN EN 12297 : 1998 | Identical |
| BS EN 13091:2000 | Biotechnology. Performance criteria for filter elements and filtration assemblies |
| 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 12462:1998 | Biotechnology - Performance criteria for pumps |
| 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 |
| BS EN 13312-1:2001 | Biotechnology. Performance criteria for piping and instrumentation General performance criteria |
| BS EN 13311-1:2001 | Biotechnology. Performance criteria for vessels General performance criteria |
| BS EN 12462:1998 | Biotechnology. Performance criteria for pumps |
| BS EN 13095:2000 | Biotechnology. Performance criteria for off-gas systems |
| BS EN 12469:2000 | Biotechnology. Performance criteria for microbiological safety cabinets |
| 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 13095:1999 | Biotechnology - Performance criteria for off-gas systems |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 1619:1996 | Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures |
| NFX 42 101 : 1987 | BIOTECHNOLOGIES - PROCEDURE A SUIVRE EN VUE DE TESTER L'APTITUDE D'UNE INSTALLATION DE FERMENTATION A FONCTIONNER SOUS CONDITIONS DE STERILITE |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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