The standard “ASTM D6324-11 Standard Specification for Male Condoms Made of Polyurethane” developed by the American Society for Testing and Materials (ASTM) describes the minimum requirements for individually packaged male condoms made of polyurethane. This standard also describes the minimum inspection and quality levels to be used in peer-reviewed testing. However, this standard is not intended to be a routine quality control specification for polyurethane condom manufacturing operations.
This standard is intended to assist purchasers in obtaining consistent quality male polyurethane condoms. Safe and proper use of male polyurethane condoms is beyond the scope of these test methods.
The appendices in these test methods contain important information, such as equipment or materials, that are a mandatory part of these test methods but are too detailed to be included in the main text. These appendices contain information intended to provide guidance.
Tensile properties determined by this test method are valuable for the identification and characterization of materials for control and specification purposes.
New polymer materials are being developed for male condoms. This standard is intended to define test methods whose results will adequately describe the design and quality of condoms made of polyurethane material. These test methods are not intended to be restrictive in design. Condom design should be verified prior to use.
Male condoms made of polyurethane are especially suitable for people who are allergic to latex. Polyurethane condoms help reduce the risk of contracting HIV and sexually transmitted infections during sex.
Made from a durable form of plastic, polyurethane condoms are a good alternative to latex condoms. These types of condoms are stronger than latex and are ideal for people with latex allergies.
ASTM D6324-11 is intended to provide specifications to adequately describe the design and quality of condoms made of polyurethane material. This standard is not intended to be restrictive in design. Condom design should be verified prior to use.
This standard provides test methods to validate the material of construction for a polyurethane condom and then verify that the material is suitable for the male condom by in-use performance testing. Existing products in commerce at the time this standard is published are considered to be compliant with this standard. Validation of a polyurethane condom material for line extensions will still need to be undertaken or, alternatively, individual performance user studies will need to be conducted.
Condoms are manufactured from polyurethane materials. The biocompatibility of the finished product, including any dressing material, is assessed according to ISO 10993 standard or equivalent.
Samples for testing shall be randomly selected from a defined batch. The sampling plan shall conform to the requirements listed in the table within the standard. To prevent inadvertent damage, operators shall wear gloves, finger sleeves or other suitable hand/finger coverings and shall exercise reasonable care when handling the package or polyurethane condom to minimize the possibility of damage during the test procedure. Manufacturers may use process control tests to determine polyurethane condom properties. Finished polyurethane condoms are used for qualification and referee testing.
Batch means a collection of condoms having the same design, color, shape, size and formula, manufactured continuously and at substantially the same time using the same process, raw materials or the same specifications, common equipment and packaged in the same type of individual container with the same lubricant and other additives or dressing. The maximum batch size is 500 thousand condoms.
This standard specifies a method for measuring the length of a polyurethane condom. The level of examination is given in the table within this standard. The length of the condom is measured to the nearest 1 mm using the test method described in the appendix to the standard (Annex A1). Precision and deviation for measuring length are included in ASTM D3492-16.
This standard specifies a method for measuring the width of a polyurethane condom. The level of inspection is given in the table within this standard. Using the test method described in the appendix to the standard, the width of a condom laid flat less than 30 mm from the open end is measured to the nearest 0,5 mm (Appendix A4). Precision and deviation for measuring width are included in ASTM D3492-16.
The thickness of condoms is measured after they have dried for at least 16 hours at room temperature. Any dressing (lubricant) should be carefully removed with absorbent paper. The wall thickness is measured at three points, 30 plus/minus 5 mm, 90 plus/minus 5 mm and 150 plus/minus 5 mm from the closed end of the condom, excluding the reservoir end. The thickness measuring device shall be as specified in ASTM D3767-03. The test method given in the appendix of the standard shall be used (Appendix A6). When a condom is textured, the thickness is measured in the non-textured area. Measurements are reported to the nearest 0,01 mm. Precision and bias for measuring thickness are given in ASTM D3492-16.
Polyurethane condoms that burst during testing or show any signs of leakage at the test site, including leakage, microdroplets, squirts, etc., except for leakage at a distance of 25 mm or less from the open end, are considered to have failed.
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