BS EN 13091:2000
Current
The latest, up-to-date edition.
Biotechnology. Performance criteria for filter elements and filtration assemblies
Hardcopy , PDF
English
15-03-2000
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Hazards
5 Performance classes
6 Classification and verification of performance
7 Marking and packaging
8 Documentation
Annex A (informative) Guidance on test methods
Bibliography
Defines performance criteria for filter elements and filtration assemblies used for biotechnological processes regarding the potential risks of microorganisms used for the worker and environment. Applicable where the intended use of the filter elements of filtration assemblies includes hazardous or possibly hazardous microorganisms used for biotechnological processes, and/or when exposure of the worker or environment is restricted for safety reasons,
| Committee |
BTI/1
|
| DevelopmentNote |
Supersedes 97/126795 DC (03/2005)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
| Standards | Relationship |
| I.S. EN 13091:2000 | Identical |
| UNI EN 13091 : 2001 | Identical |
| NEN EN 13091 : 2000 | Identical |
| UNE-EN 13091:2000 | Identical |
| NS EN 13091 : 1ED 2000 | Identical |
| NBN EN 13091 : 2000 | Identical |
| SN EN 13091 : 2000 | Identical |
| NF EN 13091 : 2000 | Identical |
| EN 13091:1999 | Identical |
| DIN EN 13091:2000-02 | Identical |
| EN 12297:1998 | Biotechnology - Equipment - Guidance on testing procedures for sterilizability |
| EN 12298:1998 | Biotechnology - Equipment - Guidance on testing procedures for leaktightness |
| EN ISO 4288:1997 | Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture (ISO 4288:1996) |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| FED-STD-209 Revision E:1992 | AIRBORNE PARTICULATE CLEANLINESS CLASSES IN CLEANROOMS AND CLEAN ZONES |
| EN 12460:1998 | Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk |
| EN 1620:1996 | Biotechnology - Large-scale process and production - Plant building according to the degree of hazard |
| EN 1672-2:2005+A1:2009 | Food processing machinery - Basic concepts - Part 2: Hygiene requirements |
| EN 1619:1996 | Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| EN 12296:1998 | Biotechnology - Equipment - Guidance on testing procedures for cleanability |
| BS 3928:1969 | Method for sodium flame test for air filters (other than for air supply to I.C. engines and compressors) |
| EN 1070 : 1998 | SAFETY OF MACHINERY - TERMINOLOGY |
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