ISO 29942

Prophylactic dams – Requirements and test methods

Summary

ISO 29942 provides the test methods and data requirements to evaluate a prophylactic dam product (such as a latex membrane) for a range of properties, including viral barrier properties, biocompatibility, surface finish, tensile properties, stability and shelf-life, freedom from holes, visible defects and packaging and labeling.  The evaluation of viral barrier properties (i.e., blocking virus from penetration through the test product) is described in Annex F and the test uses bacteriophage phiX174 as a representative virus.  The test consists of placing the dame with virus fluid above it and a collection buffer below it

Typical Test Substances

• Prophylactic dams (e.g. latex membrane, etc.)

Outline of Test Procedure

• Clamp the test dam into test apparatus with O-ring 
• Introduce collection buffer to the space under the same
• Add challenge viral fluid above the dam
• Apply pressure and hold for at least 30 minutes
• Mix and 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)
• ISO 25841 (for female 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)