SENSITIVITY OF WATER LEAK TESTS FOR LATEX CONDOMS

As part of quality assurance testing, latex condoms are often screened for pinholes using water leak tests. This report analyzes the sensiti vity of two similar tests, both requiring that a condom be filled with 300 mL of water and then examined visually for leakage. One test, a F ood and Drug Administration protocol, specifies that the condom be fil led vertically, the open end pinched off, and then rolled horizontally on a towel. The second test, developed by the American Society for Te sting and Materials, is the same, except the condom is not rolled, mer ely placed in a horizontal position and examined. Detectability of a d efect is dependent on the pressure developed within the condom, wettab ility of the condom surface by the water, thickness, and expansion of the condom. Three brands and nine different models were studied to det ermine the range of values for these variables and the sensitivity of the tests were then calculated. Sensitivity (minimum hole size detecta ble) varies from approximately 100 mum radius to 3 mum radius. Note th at the smallest defect observable is larger than the HIV virus.