ISO Standard 19671 for Condom Compatibility Testing Published

With these variations in place, the immediate question is 'Should I test to ASTM D 7661 or ISO 19671’?. At this time, it seems wise to continue using the ASTM standard, as the new standard has not yet been recognised by the FDA.

Some important changes are that the ISO includes mention of topical medicinal products and measurement of their interaction with condoms. The sample size is increased from 20 to 30, but the baseline control is not present in this test programme. Also new is the requirement to ensure that the material thickness of the condoms is within the specifications of ISO 4074.

The method of application of the lubricant to the condom is completely different, using a brush-on method with a defined volume. Although this may be more realistic than the ASTM dipping and soaking method, it requires care to ensure complete application.

The acceptance criteria in the ISO standard are similar to those proposed by the FDA, albeit with a more formal definition of the statistics. The comparison, however, is to a distilled water control rather than the baseline.

Both routes still only consider latex condoms. At MET we apply the same methods to poly-urethane and polyisoprene products.

Overall the difference between the two methods are significant. It remains to be seen if the result are comparable.

More information on the personal lubricant and topical medicine testing services can be found here.