November 11, 2015
UNITED STATES - The American Society for Testing and Materials (ASTM) released ASTM D3492 - 15 Standard Specification for Rubber Contraceptives (Male Condoms) The standard specifies the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use, and establishes the following requirements that need to be identified by the manufacturer:
- Sampling plan
- Sample handling
- Process controls
- Lot
- Dimensional test for length, width, and thickness
- Determination of tensile properties of rubber contraceptives such as breaking force, tensile strength, and ultimate elongation, as is and subjected to accelerated aging test
- Air burst properties such as burst pressure and burst volume
- Leakage
The standard does not cover the following:
- Specifications for lubricants or other dressing materials that may be applied to condoms
- Safe and proper use of condoms