The testing is conducted according to established ASTM methods and FDA guidance. The personal lubricant compatibility consists of testing against latex and/or non-latex condoms to evaluate the compatibility with the condom material, according to method ASTM D7661-10. The compatibility is determined by the percentage change of air burst parameters (burst volume and burst pressure) and tensile parameters (break force and elongation) between the treated and untreated condoms.
The results of the testing following this standard usually affect lubricant labeling with respect to condom use. This testing required for the FDA 510(k) pre-market notification submission of personal lubricants. The condoms testing suite at EMSL Analytical, inc. consists of evaluation of the air burst and tensile parameters. These tests are used for evaluation of both latex and synthetic condoms and are performed in compliance with ASTM D3492-08 (for natural rubber latex condoms) and ASTM D6324-11 (for synthetic condoms).
Example of reporting for Personal Lubricants Testing per FDA requirements:
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