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BS EN 13091:2000

Current

Current

The latest, up-to-date edition.

Biotechnology. Performance criteria for filter elements and filtration assemblies

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-03-2000

€156.59
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Hazards
5 Performance classes
6 Classification and verification of performance
7 Marking and packaging
8 Documentation
Annex A (informative) Guidance on test methods
Bibliography

Defines performance criteria for filter elements and filtration assemblies used for biotechnological processes regarding the potential risks of microorganisms used for the worker and environment. Applicable where the intended use of the filter elements of filtration assemblies includes hazardous or possibly hazardous microorganisms used for biotechnological processes, and/or when exposure of the worker or environment is restricted for safety reasons,

Committee
BTI/1
DevelopmentNote
Supersedes 97/126795 DC (03/2005)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Standards Relationship
I.S. EN 13091:2000 Identical
UNI EN 13091 : 2001 Identical
NEN EN 13091 : 2000 Identical
UNE-EN 13091:2000 Identical
NS EN 13091 : 1ED 2000 Identical
NBN EN 13091 : 2000 Identical
SN EN 13091 : 2000 Identical
NF EN 13091 : 2000 Identical
EN 13091:1999 Identical
DIN EN 13091:2000-02 Identical

EN 12297:1998 Biotechnology - Equipment - Guidance on testing procedures for sterilizability
EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
EN ISO 4288:1997 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture (ISO 4288:1996)
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
FED-STD-209 Revision E:1992 AIRBORNE PARTICULATE CLEANLINESS CLASSES IN CLEANROOMS AND CLEAN ZONES
EN 12460:1998 Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
EN 1620:1996 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
EN 1672-2:2005+A1:2009 Food processing machinery - Basic concepts - Part 2: Hygiene requirements
EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 12296:1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability
BS 3928:1969 Method for sodium flame test for air filters (other than for air supply to I.C. engines and compressors)
EN 1070 : 1998 SAFETY OF MACHINERY - TERMINOLOGY

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