BS EN 12297:1998
Current
The latest, up-to-date edition.
Biotechnology. Equipment. Guidance on testing procedures for sterilizability
Hardcopy , PDF
English
15-09-1998
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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
Provides guidance on general test methods for assessment of the sterilizability for micro-organisms of equipment (components and units of equipment) for biotechnological processes. Applies to plants or components, eg valves and fittings, tanks, pumps, piping separating and filling devices, in addition to instrumentation in contact with process fluids.
| Committee |
BTI/1
|
| DevelopmentNote |
Supersedes 96/121001 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN 12297:1998 | Identical |
| UNI EN 12297 : 2000 | Identical |
| EN 12297:1998 | Identical |
| UNE-EN 12297:1998 | 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 |
| 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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