Name: EN 12460:1998
Brand: CEN

Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

Published date

18-02-1998

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Definitions
3 Procedure for selection of equipment
4 Verification of performance in practice
5 Control
6 Documentation
Annex A (informative) Examples for a risk analysis
Annex B (informative) Bibliography

This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.

Committee	CEN/TC 233
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
NBN EN 12460 : 1998	Identical
NEN EN 12460 : 1998	Identical
SN EN 12460 : 1998	Identical
I.S. EN 12460:1998	Identical
UNI EN 12460 : 2000	Identical
NS EN 12460 : 1ED 1999	Identical
BS EN 12460:1998	Identical
UNE-EN 12460:1998	Identical
NF EN 12460 : 1998	Identical
PN EN 12460 : 2002	Identical
DIN EN 12460:1998-04	Identical

BS EN 13311-5:2001	Biotechnology. Performance criteria for vessels Kill tanks
BS EN 13091:2000	Biotechnology. Performance criteria for filter elements and filtration assemblies
EN 13311-4:2001	Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
EN 13311-1:2001	Biotechnology - Performance criteria for vessels - Part 1: General performance criteria
EN 12884:1999	Biotechnology - Performance criteria for centrifuges
EN 13311-5:2001	Biotechnology - Performance criteria for vessels - Part 5: Kill tanks
EN 13312-1:2001	Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria
EN 12690:1999	Biotechnology - Performance criteria for shaft seals
BS EN 12884:1999	Biotechnology. Performance criteria for centrifuges
BS EN 12885:1999	Biotechnology. Performance criteria for cell disrupters
BS EN 13311-1:2001	Biotechnology. Performance criteria for vessels General performance criteria
BS EN 13311-4:2001	Biotechnology. Performance criteria for vessels Bioreactors
BS EN 13095:2000	Biotechnology. Performance criteria for off-gas systems
BS EN 12690:1999	Biotechnology. Performance criteria for shaft seals
EN 13092:1999	Biotechnology - Equipment - Guidance on sampling and inoculation procedures
EN 13095:1999	Biotechnology - Performance criteria for off-gas systems

EN 12297:1998	Biotechnology - Equipment - Guidance on testing procedures for sterilizability
EN 12298:1998	Biotechnology - Equipment - Guidance on testing procedures for leaktightness
EN 1050 : 1996	SAFETY OF MACHINERY - PRINCIPLES FOR RISK ASSESSMENT
EN 1620:1996	Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
EN 1619:1996	Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
EN 12296:1998	Biotechnology - Equipment - Guidance on testing procedures for cleanability

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EN 12460:1998

Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory