Name: EN 12297:1998
Brand: CEN

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

Published date

18-03-1998

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Definitions
3 Testing
4 Documentation
Annex A (informative) Guidance on selection of
sterilizability testing
Annex B (informative) Information on test methods for
sterilizability
Annex C (informative) Bibliography

This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

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

Standards	Relationship
BS EN 12297:1998	Identical
I.S. EN 12297:1998	Identical
UNI EN 12297 : 2000	Identical
UNE-EN 12297:1998	Identical
PN EN 12297 : 2002	Identical
NEN EN 12297 : 1998	Identical
NS EN 12297 : 1ED 1999	Identical
NF EN 12297 : 1998	Identical
DIN EN 12297:1998-05	Identical
SN EN 12297 : 1998	Identical
NBN EN 12297 : 1998	Identical

BS EN 13091:2000	Biotechnology. Performance criteria for filter elements and filtration assemblies
EN 12469:2000	Biotechnology - Performance criteria for microbiological safety cabinets
EN 13311-1:2001	Biotechnology - Performance criteria for vessels - Part 1: General performance criteria
EN 12884:1999	Biotechnology - Performance criteria for centrifuges
EN 12462:1998	Biotechnology - Performance criteria for pumps
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
EN 13091:1999	Biotechnology - Performance criteria for filter elements and filtration assemblies
BS EN 12460:1998	Biotechnology. Large-scale process and production. Guidance on equipment selection and installation in accordance with the biological risk
BS EN 12884:1999	Biotechnology. Performance criteria for centrifuges
BS EN 12885:1999	Biotechnology. Performance criteria for cell disrupters
BS EN 13312-1:2001	Biotechnology. Performance criteria for piping and instrumentation General performance criteria
BS EN 13311-1:2001	Biotechnology. Performance criteria for vessels General performance criteria
BS EN 12462:1998	Biotechnology. Performance criteria for pumps
BS EN 13095:2000	Biotechnology. Performance criteria for off-gas systems
BS EN 12469:2000	Biotechnology. Performance criteria for microbiological safety cabinets
BS EN 12690:1999	Biotechnology. Performance criteria for shaft seals
EN 12460:1998	Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
EN 13095:1999	Biotechnology - Performance criteria for off-gas systems

EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
EN 1619:1996	Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
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 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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EN 12297:1998

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory