BS EN 13311-1:2001
Current
The latest, up-to-date edition.
Biotechnology. Performance criteria for vessels General performance criteria
Hardcopy , PDF
English
15-05-2001
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Foreword
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
Bibliography
Specifies performance criteria for vessels used in biotechnological processes with respect to the potential hazards to the worker and the environment from microorganisms in use.
| Committee |
BTI/1
|
| DevelopmentNote |
Supersedes 98/124253 DC. (05/2005) Reviewed and confirmed by BSI, October 2014. (09/2014)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
| Standards | Relationship |
| I.S. EN 13311-1:2001 | Identical |
| SN EN 13311-1 : 2001 | Identical |
| NS EN 13311-1 : 1ED 2001 | Identical |
| DIN EN 13311-1:2001-06 | Identical |
| EN 13311-1:2001 | Identical |
| NEN EN 13311-1 : 2001 | Identical |
| UNI EN 13311-1 : 2001 | Identical |
| UNE-EN 13311-1:2001 | Identical |
| NF EN 13311-1 : 2001 | Identical |
| NBN EN 13311-1 : 2001 | Identical |
| EN 12297:1998 | Biotechnology - Equipment - Guidance on testing procedures for sterilizability |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| 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 |
| 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 |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| 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) |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN 12296:1998 | Biotechnology - Equipment - Guidance on testing procedures for cleanability |
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