Comparison of ISO/FDA and ASTM condom water leak test methods

This research compares the ISO/FDA and ASTM water leak test methods for det ecting defects in latex and synthetic condoms. Detection rates of standardi zed 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 met hod (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 mum laser defects in polyurethane a nd 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 n umber of condoms tested, only four combinations of material, defect type, a nd hole location showed statistically significant differences in detection rates for ISO/FDA versus ASTM methods. Data produced by this research may h elp harmonize the ASTM and ISO/FDA water leak test methods.