ISSN: 0090-3973
Page Count: 6

Characterization and Creation of Defects in Condoms

Kerr, LN
Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist,Winchester Engineering and Analytical Center, U. S. Food and Drug Administration,MA,

Chaput, MP
Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist,Winchester Engineering and Analytical Center, U. S. Food and Drug Administration,MA,

Boyd, SM
Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist,Winchester Engineering and Analytical Center, U. S. Food and Drug Administration,MA,

Galevi, EA
Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist,Winchester Engineering and Analytical Center, U. S. Food and Drug Administration,MA,

Millward, PA
Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist,Winchester Engineering and Analytical Center, U. S. Food and Drug Administration,MA,

(Received 10 May 2000; accepted 31 October 2000)

Abstract

Defects in condoms were examined, then characterized and compared with defects introduced using various techniques. Eighty-five percent of the condom defects examined were classified as either a hole (void in material) or a slit (puncture). Laser drilling and puncturing with a 160 μm diameter acupuncture needle artificially introduced similar types of defects. Microscopic examination of the created defects, before and after FDA water leak testing, showed that this test method does not increase the size of preexisting microscopic defects. Examination also showed that these creation techniques generated reproducible defects within a condom type, with the size of acupuncture needle defects varying less than laser drilled defects. Results of water leak testing showed that the leakage characteristics of defects are affected by the material type, the condom shape and size, the type of defect and the defect size, and the presence of lubricant.

Keywords:
condoms, water leak test, defects, defect creation, characterization, latex, synthetic, polyurethane, holes, slits

Paper ID: JTE12248J
DOI: 10.1520/JTE12248J
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