ASTM D6324-11

New polymer materials for male condoms are being developed. This standard is intended to describe the test methods whose results shall adequately describe the design and the quality of condoms made of polyurethane material.

These test methods are not intended to be design restrictive. The condom design shall be validated prior to use.

1.1 These test methods cover and shall be used to evaluate male condoms made only of polyurethane. These test methods also describe 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 These test methods are intended to assist buyers in obtaining polyurethane condoms of consistent quality. The safe and proper use of 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 is 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 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 and health practices and determine the applicability of regulatory limitations prior to use.

A1.1.1 This annex covers the method for determining the length of polyurethane male condoms.

A2.1.1 This appendix covers the test method for determining the tensile properties of polyurethane condoms. Specimen elongation may be measured by extension indicators or displacement of gauge marks.

A4.1.1 Experience has shown that the water leakage test is most sensitive when the condom is filled while hanging vertically, its top is closed off, and the condom is placed in a horizontal position while it is examined for leaks. With this technique, the internal pressure over the entire condom surface is approximately uniform.

X1.1.1 This appendix covers the methods for determining the thickness of polyurethane male condoms.

X2.1.1 This appendix outlines a test method for determining the bursting volume and bursting pressure of polyurethane condoms. This test method is patterned after standard methods typically used in determining the air inflation properties of latex condoms. The testing apparatus and the procedure may not be appropriate for all types of polyurethane materials and product designs, and, therefore, it is inappropriate to establish a minimum requirement for volume.

X2.1.2 Following a more extensive review of existing and proposed polyurethane condom products, it may be more appropriate to categorize the marketed products by material type and design, and to develop separate test methods for each, after which, appropriate minimum requirements for volume can be established, consistent with the physical properties of the individual material types.

X3.1.1 This appendix covers the test method for determining the strength of welded seams of polyurethane condoms.