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EN 12296:1998

Current

Current

The latest, up-to-date edition.

Biotechnology - Equipment - Guidance on testing procedures for cleanability

Published date

18-03-1998

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Foreword
Introduction
1 Scope
2 Definitions
3 Testing
4 Documentation
Annex A (informative) Selection guide on test methods
        for cleanliness
Annex B (informative) Information on test methods for
        cleanliness
Annex C (informative) Bibliography

This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.

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

Standards Relationship
PN EN 12296 : 2002 Identical
NF EN 12296 : 1998 Identical
UNI EN 12296 : 2000 Identical
UNE-EN 12296:1998 Identical
NEN EN 12296 : 1998 Identical
I.S. EN 12296:1998 Identical
SN EN 12296 : 1998 Identical
DIN EN 12296:1998-05 Identical
BS EN 12296:1998 Identical
GOST R EN 12296 : 2009 Identical
NS EN 12296 : 1ED 1999 Identical
NBN EN 12296 : 1998 Identical

ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
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
01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
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 ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
EN ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
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
DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

EN ISO 9000-1 : 1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE (ISO 9000-1:1994)
EN 626-2:1996+A1:2008 Safety of machinery - Reduction of risk to health from hazardous substances emitted by machinery - Part 2: Methodology leading to verification procedures
EN 626-1:1994+A1:2008 Safety of machinery - Reduction of risks to health from hazardous substances emitted by machinery - Part 1: Principles and specifications for machinery manufacturers
ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use

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