By Jennifer Gygi, Study Director, Packaging
Over the last 5+ years, the FDA has been tightening the regulations on personal lubricants to ensure they are safe since they are often used in body contact and also to ensure they do not degrade condoms. The new ASTM D7661-10 standard is the FDA approved method for determining condom compatibility. This new standard clearly lays out the required sample numbers and test methodology for demonstrating condom compatibility.
Basically, if a manufacturer claims their personal lubricant is latex and/or condom safe they need to prove it. All personal lubricants are required to have 510K approval. Manufacturers also need to do biocompatibility testing, to make sure the lubricant will not cause any bodily harm to humans.
Nelson Labs performs the ASTM D7661 Lubricant Compatibility with Condoms test. Condoms are tested in sets of 20, with a set of baseline, control, lubricant, and mineral oil for each condom brand. The condoms should be non-lubricated, non-textured and all from the same lot. A minimum of three brands of latex should be tested to claim “latex compatibility.” To claim “condom compatibility” the test should also use at least one polyisoprene and one polyurethane condom as well.
The better the condom performs overall during the testing, the more likely it is that it will do well when exposed to lubricant.