Volume 29, Issue 2 (March 2001)

    Comparison of ISO/FDA and ASTM Condom Water Leak Test Methods

    (Received 2 October 2000; accepted 20 November 2000)

    CODEN: JTEOAD

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    Abstract

    This research compares the ISO/FDA and ASTM water leak test methods for detecting defects in latex and synthetic condoms. Detection rates of standardized defects are quantified for four condom materials. The overall detection rate of the ISO/FDA method (53.4%) averages 12.3% higher than the ASTM method (41.1%) and is higher for each of the four condom materials. Detection rates for both test methods vary significantly by condom material. The ISO/FDA method is effective in detecting 30 μm laser defects in polyurethane and latex condoms (79.9 and 69.7%, respectively), but is not very effective in baggy and high elongation condoms (24.4 and 39.7%). Due to the limited number of condoms tested, only four combinations of material, defect type, and hole location showed statistically significant differences in detection rates for ISO/FDA versus ASTM methods. Data produced by this research may help harmonize the ASTM and ISO/FDA water leak test methods.


    Author Information:

    Kerr, LN
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Boivin, WS
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Hamilton, SL
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Mailhot, SA
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    O'Malley, LG
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Boyd, SM
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Pierdominici, VJB
    Mechanical engineer, physicist, mechanical engineer, chemical engineer, electronics technician, biomedical engineer, and computer engineer, Food and Drug Administration, Winchester Engineering and Analytical Center, Winchester, MA

    Bushar, HF
    Statistician, Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Rockville, MD


    Stock #: JTE12245J

    ISSN: 0090-3973

    DOI: 10.1520/JTE12245J

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    Author
    Title Comparison of ISO/FDA and ASTM Condom Water Leak Test Methods
    Symposium , 0000-00-00
    Committee D11