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EN 13311-1:2001

Current

Current

The latest, up-to-date edition.

Biotechnology - Performance criteria for vessels - Part 1: General performance criteria

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
Bibliography

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.

Committee
CEN/TC 233
DevelopmentNote
Supersedes PREN 13311-1. (10/2005)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

BS EN 13311-5:2001 Biotechnology. Performance criteria for vessels Kill tanks
EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
EN 13311-2:2001 Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices
EN 13311-6:2001 Biotechnology - Performance criteria for vessels - Part 6: Chromatography columns
EN 13311-5:2001 Biotechnology - Performance criteria for vessels - Part 5: Kill tanks
BS EN 13311-4:2001 Biotechnology. Performance criteria for vessels Bioreactors
BS EN 13311-2:2001 Biotechnology. Performance criteria for vessels Pressure protection devices
BS EN 13311-3:2001 Biotechnology. Performance criteria for vessels Glass pressure vessels
BS EN 13311-6:2001 Biotechnology. Performance criteria for vessels Chromatography columns
EN 13311-3:2001 Biotechnology - Performance criteria for vessels - Part 3: Glass pressure vessels

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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