Standard specifications for rubber contraceptives (condoms). American National Standard ANSI/ASTM D 3492-77.
This document describes the requirements for condoms made of rubber latex intended for single use as specified by the American Society for Testing and Materials (ASTM) in 1977. Condoms must be manufactured from good quality rubber latex; they may be transparent, translucent, opaque, or colored. Condoms must not liberate toxic or otherwise harmful substances. The open end of condoms must end with an integral rim. 10 condoms out of a batch of 144,000 at most must be tested for design, including length, width, thickness, and mass or weight. Length must be from 160 mm to 180 mm +or- 10 depending on smooth or textured surface and on width; width must be from 49 mm to 52 mm +or- 2-3, again depending on type of surface; thickness must be 0.04 mm +or- 0.07-0.09, and maximum weight must be from 1.50 g to 1.95 g depending on smooth or textured surface. 25 condoms out of a batch of 144,000 at most must be tested for tensile properties, including tensile strength and elongation at breaking. Inspection for leakage must follow ISO 2859, General Inspection Level 1 for an acceptable quality level of 0.4%. Each condom must be filled with 300 cu cm of water and inspected for holes. Each condom must be marked with the manufacturer's name and date of manufacture. Every package must have name and address of manufacturer or distributor, and the name of the country of manufacture. Proper packaging should protect condoms for 10 years or more. Condoms should not be kept in storage longer than necessary, and should be stored in a cool place. One retest is possible before final rejection of lots not conforming to design and physical requirements. No retest is permissible for lots not conforming to test for quality assurance (leakage).