ISO 29942:2011

Overview

ISO 29942:2011 - Prophylactic dams - Requirements and test methods - defines minimum requirements, sampling and test methods for prophylactic dams (polymer films used to cover the external female genitalia or anal area during sexual activity). The standard focuses on barrier performance to help prevent sexually transmitted infections (STIs), product safety (biocompatibility), physical integrity, packaging, labelling and shelf-life verification. It treats prophylactic dams as non‑sterile medical devices produced under a controlled quality system.

Key topics and technical requirements

• Scope and purpose: Requirements and test methods for prophylactic dams intended to reduce STI transmission.
• Design limits:
  • Length: 200 mm to 350 mm (sampled 13 dams/lot, Annex C).
  • Width: 150 mm to 250 mm (sampled 13 dams/lot, Annex C).
  • Thickness: mean ≤ 0.15 mm; individual readings must be between 75% and 125% of the mean (Annex D). For natural rubber latex, no reading