EN 12347:1998
Current
The latest, up-to-date edition.
18-03-1998
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Hazards
5 Performance classification
6 Classification of steam sterilizers and autoclaves
7 Verification of performance
8 Marking and packaging
9 Documents
Annex A (informative) Bibliography
This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
| Committee |
CEN/TC 233
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN 12347 : 2000 | Identical |
| NBN EN 12347 : 1998 | Identical |
| I.S. EN 12347:1998 | Identical |
| NEN EN 12347 : 1998 | Identical |
| PN EN 12347 : 2002 | Identical |
| NF EN 12347 : 1998 | Identical |
| BS EN 12347:1998 | Identical |
| UNE-EN 12347:1998 | Identical |
| NS EN 12347 : 1ED 1999 | Identical |
| DIN EN 12347:1998-06 | Identical |
| SN EN 12347 : 1998 | Identical |
| I.S. CR 12739:1999 | BIOTECHNOLOGY - LABORATORIES FOR RESEARCH, DEVELOPMENT AND ANALYSIS - REPORT ON THE SELECTION OF EQUIPMENT NEEDED FOR BIOTECHNOLOGY LABORATORIES ACCORDING TO THE DEGREE OF HAZARD |
| EN 12738:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments |
| EN 12128:1998 | Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements |
| EN 12740:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste |
| EN 13441:2001 | Biotechnology - Laboratories for research, development and analysis - Guidance on containment of genetically modified plants |
| EN 12741:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations |
| DIN EN 12128:1998-05 | BIOTECHNOLOGY - LABORATORIES FOR RESEARCH, DEVELOPMENT AND ANALYSIS - CONTAINMENT LEVELS OF MICROBIOLOGY LABORATORIES, AREAS OF RISK, LOCALITIES AND PHYSICAL SAFETY REQUIREMENTS |
| BS EN 12738:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for containment of animals inoculated with microorganisms in experiments |
| BS EN 12740:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for handling, inactivating and testing of waste |
| BS EN 12741:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for biotechnology laboratory operations |
| BS EN 13441:2002 | Biotechnology. Laboratories for research, development and analysis. Guidance on containment of genetically modified plants |
| PD 6632:1998 | Biotechnology. Laboratories for research, development and analysis. Guidance on the selection of equipment needed for biotechnology laboratories according to the degree of hazard |
| CR 12739 : 1998 | BIOTECHNOLOGY - LABORATORIES FOR RESEARCH, DEVELOPMENT AND ANALYSIS - REPORT ON THE SELECTION OF EQUIPMENT NEEDED FOR BIOTECHNOLOGY LABORATORIES ACCORDING TO THE DEGREE OF HAZARD |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 1620:1996 | Biotechnology - Large-scale process and production - Plant building according to the degree of hazard |
| EN 866-1 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS |
| 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 867-2 : 1997 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - PROCESS INDICATORS (CLASS A) |
| EN 867-1 : 1997 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| EN 866-3 : 1997 | BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS |
| ISO 4287-1:1984 | Surface roughness — Terminology — Part 1: Surface and its parameters |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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