|Number of pages||18|
1.1 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 specifications for lubricants or other dressing materials that may be applied to condoms except as noted in .
1.2 This specification is intended to assist buyers in obtaining condoms of consistent quality. The safe and proper use of condoms is excluded from the scope of this specification.
1.3 The applicability of this specification is as a design guideline and a reference test specification. It is not intended to be a routine quality control specification for condom manufacturing operations.
1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatory part of the specification but too detailed for inclusion in the main text.
1.5 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.
1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standard to determine testing methodology and substantiate the appropriateness of that methodology to assure the quality of the condoms to the purchaser and to the government regulatory authority having jurisdiction.
1.7 Regulatory bodies may require additional information, such as clinical data, to support the condom sizes subject to this standard.
1.8 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
|English title||Standard Specification for Rubber Contraceptives (Male Condoms)|