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

• Published in: Journal of testing and evaluation 2001-03, Vol.29 (2), p.192-198, Article 192
• Main Authors: Kerr, LN, Boivin, WS, Hamilton, SL, Mailhot, SA, O'Malley, LG, Boyd, SM, Pierdominici, VJB, Bushar, HF
• Format: Article
• Language: English
• Subjects: Applied sciences; Exact sciences and technology; Forms of application and semi-finished materials; Latex and emulsion; Polymer industry, paints, wood; Technology of polymers
• ISSN: 0090-3973; 1945-7553
• DOI: 10.1520/JTE12245J

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.