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  • EN 866-1 : 1997

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS

    Available format(s): 

    Superseded date:  01-07-2006

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 General requirements
    5 Test organisms and their preparation for the
        manufacture of inoculated carriers
    6 Carriers and their inoculation
    7 Packaging and labelling of inoculated carriers for
        distribution
    8 Preparation of biological indicators from inoculated
        carriers
    9 Packaging and labelling of biological indicators
    10 Determination of test organism resistance
    Annexes
    A (normative) Determination of growth inhibition by
        carriers exposed to the sterilization process
    B (normative) Determination of test organism resistance
    C (informative) Relationship between the components of
        biological test systems
    D (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements for manufacturing biological systems for use in testing sterilizers and sterilizing processes.

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

    Committee TC 102
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    BS EN 866-7:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers
    BS EN 12347:1998 Biotechnology. Performance criteria for steam sterilizers and autoclaves
    EN 12740:1999 Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste
    EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
    99/124125 DC : DRAFT NOV 1999 BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS
    DIN EN 866-3:1997-05 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 3: PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    EN 866-6 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 6 - PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS
    BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
    BS EN 866-4:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in irradiation sterilizers
    BS EN 12740:1999 Biotechnology. Laboratories for research, development and analysis. Guidance for handling, inactivating and testing of waste
    BS EN 866-8:2000 Biological systems for testing sterilizers and sterilization processes Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers
    BS EN 866-6:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in dry heat sterilizers
    EN 866-8 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 8 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS
    EN 866-3 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
    EN 866-5 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 5 - PARTICULAR SYSTEMS FOR USE IN LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS
    EN 866-7 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 7 - PARTICULAR REQUIREMENTS FOR SELF-CONTAINED BIOLOGICAL INDICATOR SYSTEMS FOR USE IN MOIST HEAT STERILIZERS
    EN 866-2:1997/AC:1998 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS
    EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    EN 866-4 : 1999 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PART 4 - PARTICULAR SYSTEMS FOR USE IN IRRADIATION STERILIZERS
    02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    02/121895 DC : DRAFT APR 2002 BS EN 13060 - SMALL STEAM STERILIZERS
    BS EN 866-5:2000 Biological systems for testing sterilizers and sterilization processes Particular systems for use in low temperature steam and formaldehyde sterilizers

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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