• BS EN 867-1:1997

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Non-biological systems for use in sterilizers General requirements

    Available format(s):  Hardcopy, PDF

    Superseded date:  22-02-2006

    Language(s):  English

    Published date:  15-10-1997

    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 Classification
    5 General requirements
    6 Labelling and instructions for use
    Annex A (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements for indicators not dependent for action on living organisms or their absence, for use in monitoring the presence or attainment of one or more of the variables necessary for a satisfactory sterilizing method. Does not define requirements for the using of biological systems.

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

    Committee CH/198
    Development Note Supersedes 92/57874 DC (09/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS 7893:1997 Specification for pressure sensitive adhesive closing and sealing tapes for use with sterilization packaging materials
    BS EN 867-2:1997 Non-biological systems for use in sterilizers Process indicators (Class A)

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

    BS EN 28601:1992 Specification for representation of dates and times in information interchange
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    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
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    ISO 9001:2015 Quality management systems — Requirements
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    EN 45001 : 1989 GENERAL CRITERIA FOR THE OPERATION OF TESTING LABORATORIES
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