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BS EN 12297:1998

Current
Current

The latest, up-to-date edition.

Biotechnology. Equipment. Guidance on testing procedures for sterilizability
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-15-1998

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

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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