Full Description

1.1This 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 3.2.

1.2This 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.

1.3The 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.

1.4The 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.

1.5The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.

1.6It 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.

1.7Regulatory bodies may require additional information, such as clinical data, to support the condom sizes subject to this standard.

1.8The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.