Skip to content
Please enter a keyword to search

  • EN 12347:1998

    Current The latest, up-to-date edition.

    Biotechnology - Performance criteria for steam sterilizers and autoclaves

    Available format(s): 

    Language(s): 

    Published date:  18-03-1998

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 233
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective