【国外标准】 Standard Specification for Rubber Contraceptives (Male Condoms)

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.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.