1.1 本规范涵盖了由天然胶乳制成的一次性使用的单独包装男用避孕套的最低要求。本规范不包括可能应用于避孕套的润滑剂或其他敷料的规范，除非另有说明 3.2 . 1.2 本规范旨在帮助购买者获得质量一致的避孕套。安全和正确使用避孕套不在本规范范围内。 1.3 本规范的适用性作为设计指南和参考测试规范。它不是避孕套生产操作的常规质量控制规范。 1.4 本规范中的附录包括重要信息，如仪器或材料的信息，这些信息是本规范的强制性部分，但过于详细，无法包含在正文中。 1.5 本规范中的附录包含的信息仅供参考，不是本规范的强制性部分。 1.6 对于任何不符合本标准规范的避孕套设计，制造商应负责确定测试方法并证明该方法的适当性，以确保购买者和具有管辖权的政府监管机构的避孕套质量。 1.7 监管机构可能需要额外的信息，如临床数据，以支持符合本标准的避孕套尺寸。 1.8 以国际单位制表示的数值应视为标准。括号中给出的值仅供参考。

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 3.2 . 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.