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  • BS EN 866-1:1997

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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):  Hardcopy, PDF

    Superseded date:  31-07-2006

    Language(s):  English

    Published date:  15-11-1997

    Publisher:  British Standards Institution

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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 CH/198
    Development Note Supersedes 95/121171 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes Particular systems for use in moist heat sterilizers
    BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes Particular systems for use in ethylene oxide sterilizers

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

    BS EN 28601:1992 Specification for representation of dates and times in information interchange
    BS EN 1174-1:1996 Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
    BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods
    EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN ISO 9003:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    EN 45001 : 1989 GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES
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