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BSI
BS EN 12460:1998

BS EN 12460:1998

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-15-1998

Publisher

British Standards Institution

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 of a risk analysis
Annex B (informative) Bibliography

Provides guidance on the selecting and analysing of biotechnological equipment and subsequent assembly into a plant so as to reach the appropriate biosafety containment levels. Covers verification of installation, operation and maintenance. In addition, it is applicable when a new process or significant changes are introduced into an existing plant, and if the biotechnological process includes hazardous or potentially hazardous microorganisms and/or if the emitting of such microorganisms into the working place and/or environment are restricted.

Committee
BTI/1
DevelopmentNote
Supersedes 96/123502 DC. (08/2005)
DocumentType
Standard
Pages
10
PublisherName
British Standards Institution
Status
Current
Supersedes

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
EN 12460:1998 Identical
UNE-EN 12460:1998 Identical
NF EN 12460 : 1998 Identical
DIN EN 12460:1998-04 Identical

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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Hardcopy - English
PDF - English
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