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EN 12347:1998

Current

Current

The latest, up-to-date edition.

Biotechnology - Performance criteria for steam sterilizers and autoclaves

Published date

18-03-1998

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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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