EN 12296:1998
Current
The latest, up-to-date edition.
18-03-1998
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) |
| 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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