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Standard specifications for rubber contraceptives (condoms). American National Standard ANSI/ASTM D 3492-77.
In: American Society for Testing and Materials [ASTM]. Annual book of ASTM standards. Part 38. Philadelphia, Pennsylvania, ASTM, 1980. 13-6.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).
London, British Standards Insitute, 1979. 8 p.British Standard (BS) 3704, published in 1964 was one of the 1st standards dealing with the quality control of contraceptive devices. BS3704 had a 2nd edition in 1972, published to revise quality control techniques based on a cumulative sampling method applied to continuous production runs, to ensure that defective products did not exceed 0.5%. This document presents the 1979 revised edition of BS3704 with the requirements for condoms made of rubber latex. To test for design 1 specimen out of 10,000 must be tested for: 1) length, as determined by it being suspended over a graduate mandrel, which must not be less than 160 mm; 2) width, not less than 49 mm and not more than 56 mm; 3) thickness, no more than 0.160 mm for both smooth and textured condoms; and 4) weight, not more than 1.70 g for smooth and 1.90 g for textured condoms. 100 specimens over 10,000 must be tested for freedom from holes, as evidenced by the absence of leakage when filled with 300 ml of water and then rolled over absorbent paper. 10 specimens over 400,000, must be tested for tensile properties and for elongation at breaking point, and for color fastness. After each test a written test report is required. Rubber condoms must be packaged in sealed unit containers in such a way that the condoms are fully protected during transport and storage. Each individual container must carry the manufacturer's identification, batch number, number of contained condoms, and the date after which the condoms should not be used. Since rubber tends to deteriorate with age, condoms should not be kept in stock longer than necessary; as soon as a condom shows deterioration it should be destroyed.