Overview
ISO/TR 19969:2018 provides laboratory guidance on sample handling and preparation for two key male condom quality tests: determination of bursting volume and pressure and testing for freedom from holes. The technical report focuses on standardized procedures to minimize handling damage that can produce false failures or inconsistent results. It is intended for laboratory use only (not for end-user instructions).
Key topics
- Scope and purpose
- Guidance to improve reproducibility of mechanical and leak testing for male condoms.
- Supports testing performed against ISO 4074 and ISO 23409.
- General precautions
- Use of protective gloves (seamless medical examination gloves recommended); remove jewellery and avoid long/sharp fingernails.
- Open individual containers by tearing (do not use scissors or sharp instruments).
- Test samples promptly after unpackaging - preferably within 1 hour, definitely within 4 hours to reduce environmental damage (UV, ozone).
- Bursting volume and pressure
- Verify pressure transducer range and calibration before testing.
- Ensure the rod/mandrel surface is smooth, undamaged, and contaminant-free.
- Unroll condoms evenly onto the mandrel using both hands with minimal stretching; set clamping device carefully to avoid knocks or slippage.
- Freedom-from-holes (water/electrical leak test)
- Two recommended unrolling methods to reduce micro-damage (finger-ring method and two-finger expansion method).
- Inspect visually for defects per ISO 4074/23409; remove temporary creases by gently trapping air (without stretching).
- Attach condoms to mount with both hands, stretching no more than required (not more than 100% as noted).
- Use coloured absorbent paper (single piece, free from joints/foreign matter) when rolling samples for water leakage inspection.
- Handling after test
- Remove and handle wet specimens gently to avoid contact damage and false hole creation; avoid excessive rubbing when wiping water drops.
Applications
- Quality control and assurance laboratories performing condom mechanical and leak tests.
- Manufacturers and R&D teams validating product performance and sample-preparation protocols.
- Conformity assessment bodies and regulatory testing facilities seeking standardized, reproducible test preparation methods.
- Interlaboratory comparison studies and accreditation bodies focused on test repeatability and precision.
Related standards
- ISO 4074 - Natural rubber latex male condoms - Requirements and test methods
- ISO 23409 - Male condoms - Requirements and test methods for condoms made from synthetic materials
Keywords: ISO TR 19969, condom testing, sample handling, bursting volume, bursting pressure, freedom from holes, water leakage test, ISO 4074, ISO 23409, laboratory guidance, condom quality.
Open preview (PDF)Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom
