ISSN: 0090-3973
Page Count: 5

Sensitivity of Water Leak Tests for Latex Condoms
Herman, BA
Physicist, physicist, and biomedical engineer, Division of Physical Sciences, Center for Devices and Radiological Health, U.S. Food and Drug Administration, MD

Carey, RF
Physicist, physicist, and biomedical engineer, Division of Physical Sciences, Center for Devices and Radiological Health, U.S. Food and Drug Administration, MD

Rinaldi, JE
Physicist, physicist, and biomedical engineer, Division of Physical Sciences, Center for Devices and Radiological Health, U.S. Food and Drug Administration, MD

(Received 6 February 1992; accepted 9 September 1992)

Abstract

As part of quality assurance testing, latex condoms are often screened for pinholes using water leak tests. This report analyzes the seasitivity 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 Food and Drug Administration protocol, specifies that the condom be filled vertically, the open end pinched off, and then rolled horizontally on a towel. The second test, developed by the American Society for Testing and Materials, is the same, except the condom is not rolled, merely placed in a horizontal position and examined. Detectability of a defect is dependent on the pressure developed within the condom, wettability of the condom surface by the water, thickness, and expansion of the condom. Three brands and nine different models were studied to determine the range of values for these variables and the sensitivity of the tests were then calculated. Sensitivity (minimum hole size detectable) varies from approximately 100 μm radius to 3 μm radius. Note that the smallest defect observable is larger than the HIV virus.

Keywords:
latex, condoms, leakage tests

Paper ID: JTE11755J
DOI: 10.1520/JTE11755J
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