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  • BS EN ISO 11140-4:2007

    Current The latest, up-to-date edition.

    Sterilization of health care products. Chemical indicators Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-03-2007

    Publisher:  British Standards Institution

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    This part of ISO11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).

    NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes.

    An indicator complying with this part of ISO11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of ISO11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.

    This part of ISO11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

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    Committee CH/198
    Development Note Supersedes BS EN 867-4. (03/2007) Supersedes 05/30116432 DC. (04/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    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
    ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
    ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
    ISO 9001:2015 Quality management systems — Requirements
    ISO/CIE 10526:1999 CIE standard illuminants for colorimetry
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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