Biotechnology. Equipment. Guidance on testing procedures for sterilizability

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-09-1998

Publisher

British Standards Institution

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

Provides guidance on general test methods for assessment of the sterilizability for micro-organisms of equipment (components and units of equipment) for biotechnological processes. Applies to plants or components, eg valves and fittings, tanks, pumps, piping separating and filling devices, in addition to instrumentation in contact with process fluids.

Committee	BTI/1
DevelopmentNote	Supersedes 96/121001 DC. (08/2005)
DocumentType	Standard
Pages	14
PublisherName	British Standards Institution
Status	Current
Supersedes	96/121001 DC : FEB 96

Standards	Relationship
I.S. EN 12297:1998	Identical
UNI EN 12297 : 2000	Identical
EN 12297:1998	Identical
UNE-EN 12297:1998	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

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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BS EN 12297:1998

Biotechnology. Equipment. Guidance on testing procedures for sterilizability

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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