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  • EN 867-3:1997/AC:1998

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST

    Available format(s): 

    Superseded date:  01-03-2007

    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 Indicator system format
    6 Performance requirements
    7 Packaging and labelling
    8 Quality assurance
    Annex A (normative) Method for determining strength after
                        steam sterilization
    Annex B (normative) Method for the estimation of the visual
                        difference between the colour of the
                        substrate and the changed (or unchanged)
                        indicator system by determination of the
                        relative reflectance density
    Annex C (normative) Method for determining colour change on
                        exposure to dry saturated steam
    Annex D (normative) Method for determining indicator colour
                        change on exposure to dry heat
    Annex E (normative) Ageing of test samples
    Annex F (normative) Method for evaluating transfer of
                        indicator to standard test pack on
                        processing
    Annex G (normative) Method for demonstrating the shelf life
                        of the product
    Annex H (normative) Steam exposure apparatus
    Annex J (normative) Method for determining the sensitivity
                        of the indicator to the presence of air
    Annex K (normative) Air injection system
    Annex L (normative) Standard test pack

    Abstract - (Show below) - (Hide below)

    Defines criteria for an indicator for use in the Bowie and Dick test for steam sterilizers for wrapped items, such as instruments and porous metals.

    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)

    02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS EN 867-5:2001 Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    I.S. EN ISO 11140-3:2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
    AAMI ISO 11140-3 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
    AAMI ISO 11140-3 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
    BS EN 867-4:2001 Non-biological systems for use in sterilizers Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration
    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

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

    ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
    ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets
    EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
    ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
    ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
    EN 867-1 : 1997 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
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