ISO 16037:2002

Overview

ISO 16037:2002 - "Rubber condoms for clinical trials - Measurement of physical properties" is a practical guideline for clinical researchers and testing laboratories. It describes a set of laboratory tests and sampling recommendations to characterize the physical properties of condoms used in clinical investigations. The standard is intended to help relate clinical outcomes (acceptability, failure rates) to the design and quality of the condoms tested and is not a protocol for clinical trial design. Although written mainly for natural rubber condoms, the principles can be applied to other materials.

Key Topics

The standard specifies measurable physical properties, sample sizes and test methods to be performed prior to (and during long) clinical studies:

• Length and width
  • Measure 13 condoms per lot; record lot mean and standard deviation.
  • Width profile measured every 10 mm between 30 mm from each end.
• Thickness
  • At least 13 condoms measured in the shaft/reservoir transition with a micrometer (resolution 0.01 mm) or by weighing method (ISO 4074 formula).
• Bead (rim)
  • Measure bead length and thickness on 13 condoms.
• Air inflation (burst)
  • Inflate ≥315 condoms per lot (preferably 500); record bursting pressure and volume. For reliable defectiveness estimates test ≥2 000.
• Tensile properties
  • Cut mid-body test pieces from 20 condoms per lot; record forces at 100%, 300%, 600% elongation and at break, plus elongation at break.
• Lubricant
  • Measure lubricant mass on condom and in container for 32 specimens per lot.
• Freedom from holes and visible defects
  • Aqueous leakage test on ≥315 condoms per lot; recommend ≥2 000 for robust defect rates.
• Sampling cadence
  • Test at start of study; repeat air-inflation and tensile tests every six months for studies longer than six months.
• Manufacturer information
  • Request detailed technical specifications, stability data, and safety information.

Applications

Who uses ISO 16037 and why:

• Clinical researchers conducting condom acceptability or failure studies who need to control or document product physical properties.
• Independent testing laboratories and manufacturers for lot characterization and correlation between lab results and clinical findings.
• Regulatory and quality teams seeking reproducible, standardized measurement procedures for condom physical testing.

Keywords: ISO 16037, condom testing, rubber condoms for clinical trials, measurement of physical properties, lot testing, air inflation, tensile testing.

Related Standards

• ISO 4074 - Natural latex rubber condoms - Requirements and test methods
• ISO 37 - Rubber - Determination of tensile stress–strain properties
• ISO 10993 series, ISO 14155, ISO 14971 (referenced in bibliography for safety and clinical-device context)