ISO 25841

ISO 25841 Female condoms – Requirements and test methods

Summary

ISO 25841 provides the test methods and data requirements to evaluate viral barrier properties (i.e., blocking virus from penetration through condom) of female condoms under a simulated, worst-case condition.  A small sized virus, bacteriophage phiX174, is used as a representative virus.  The test matches the principle as described in the U.S. Food and Drug administration (FDA) Centers for Devices and Radiological Health (CDRH) guidance, “Testing Guidance for male condoms made from new material” (issued June 29, 1995), and the general test procedure as described in the Lytle, Routson and Cyr. “A simple method to test condoms for penetration by viruses.” Appl. Environ. Microbiol. 58: 3180-3182, 1992.

Typical Test Substances

• Female condoms with viral barrier properties

Outline of Test Procedure

• Fill test condom with virus; attach to the test apparatus
• Submerge condom into a container with a collection buffer
• Apply pressure and hold for 30 minutes
• Analyze the collection buffer for virus using a quantitative plaque assay

Regulatory Agencies / Purpose

• U.S. Food and Drug Administration (FDA)
• Other agencies 
• R&D and Marketing

Similar Methods

• ISO 23409 (for male condoms)
• U.S. Food and Drug administration (FDA) Centers for Devices and Radiological Health (CDRH) guidance, “Testing Guidance for male condoms made from new material” (issued June 29, 1995)