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EN 13311-4:2001

Current

Current

The latest, up-to-date edition.

Biotechnology - Performance criteria for vessels - Part 4: Bioreactors

Published date

21-03-2001

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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 for determining leaktightness
        of bioreactors
Annex B (informative) Typical hazards and
        preventive measures
Bibliography

This European Standard specifies performance criteria for bioreactors 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 bioreactors 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.

Committee
CEN/TC 233
DevelopmentNote
Supersedes PREN 13311-4. (10/2005)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

BS EN 13311-3:2001 Biotechnology. Performance criteria for vessels Glass pressure vessels

EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
EN 13312-2:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 2: Couplings
EN 13311-1:2001 Biotechnology - Performance criteria for vessels - Part 1: General performance criteria
EN 13312-4:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes
EN 12460:1998 Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
EN 13312-3:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 3: Sampling and inoculation devices
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 13095:1999 Biotechnology - Performance criteria for off-gas systems
EN 13311-2:2001 Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices
EN 12490:2010 Durability of wood and wood-based products - Preservative-treated solid wood - Determination of the penetration and retention of creosote in treated wood
NFX 42 051 : 1988 BIOTECHNOLOGIES - GUIDE DE BONNES PRATIQUES DE FABRICATION INDUSTRIELLE DE SUBSTANCES CHIMIQUES ET DE PRODUITS BIOLOGIQUES OBTENUS A PARTIR DE MICROORGANISMES PATHOGENES
EN 13092:1999 Biotechnology - Equipment - Guidance on sampling and inoculation procedures
EN 13312-5:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 5: Valves

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