Standard Specification for Rubber Contraceptives (Male Condoms)
STANDARD published on 1.7.2016
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Designation standards: ASTM D3492-16
Publication date standards: 1.7.2016
The number of pages: 16
Approximate weight : 48 g (0.11 lbs)
Country: American technical standard
Category: Technical standards ASTM
This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the following: (1) specifications for lubricants or other dressing materials that may be applied to condoms and (2) safe and proper use of condoms. The applicability of this specification is as a design guideline and a reference test specification and not to be a routine quality control specification for condom manufacturing operations. The condoms and any dressing materials applied to them shall not liberate substances that are known to be toxic, sensitizing, locally irritating, or otherwise harmful to the general population under normal conditions of use. The requirements for the following are detailed: (1) sampling plan (2) sample handling, (3) process controls, (4) lot, (5) dimensional test for length, width, and thickness, (6) determination of tensile properties of rubber contraceptives such as breaking force, tensile strength, and ultimate elongation, as is and subjected to accelerated aging test, (7) air burst properties such as burst pressure and burst volume, and (8) leakage. The concept of repeatability and reproducibility for precision and bias of the tests are defined. Requirements for package integrity, labeling, and storage are specified as well.
Keywords:
condoms, contraceptives, prophylactic, rubber,, ICS Number Code 11.200 (Birth control. Mechanical contraceptives)