Full Description
1.1 This specification covers the minimum requirements for individually packaged male condoms made from polyurethane. This specification also describes the minimum inspection and quality levels that shall be utilized in referee tests. It is not intended to be a routine quality control specification for polyurethane condom manufacturing operations.
1.2 This specification is intended to assist buyers in obtaining male polyurethane condoms of consistent quality. The safe and proper use of male polyurethane condoms is excluded from the scope of these test methods.
1.3 The annexes in these test methods include important information, such as that on apparatus or materials, that are a mandatory part of these test methods but too detailed for inclusion in the main text.
1.4 The appendixes in these test methods contain information intended to provide guidance.
1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
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 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.