ISO 19671 Additional Lubricants for Male Natural Rubber Latex Condoms - Effect on Condom Strength

The standard “ISO 19671 Additional lubricants for male natural rubber latex condoms - Effect on condom potency” developed by the International Organization for Standardization (ISO) describes a procedure for evaluating the efficacy or compatibility of an additional or personal lubricant with lubricated natural rubber latex male condoms. This procedure also applies to topical medications and other substances that come into contact with such condoms. This method describes the measurement of changes in the physical properties of the condom after exposure to the test substance, i.e. lubricant, topical medication, etc., and specifies pass/fail criteria for such changes.

This standard is not applicable to the assessment of compatibility of lubricants applied to condoms during manufacture. It is not directly applicable to the assessment of the compatibility of a particular condom with lubricants or other substances. Although similar principles apply, it is not directly applicable to tests using female condoms.

The test methods are applicable to condoms made from natural rubber latex and synthetic materials, but pass/fail criteria are stipulated only for natural rubber latex.

For the purposes of this standard,

• Personal lubricant refers to additional lubricants intended to be applied by the user during condom use.
• The positive control is a test substance known to deteriorate the physical properties of the condom.
• Test substance refers to a lubricant, topical medication, or other material that is tested for compatibility with condoms.
• Topical medication refers to medication that is intended for use vaginally or rectally and may come into contact with the condom during use.

In principle, this test method determines the change in tensile properties and swelling properties of condoms after 60 minutes of contact with a lubricant or other test substance included in this standard. Rupture force is the basic and most sensitive variable used in evaluating the effect of test substances.

For the tensile test, rings cut from condoms are exposed to the test substance, warmed to body temperature, rinsed of excess test substance and tested for breaking force and percentage elongation at break in accordance with standard cultivation (Annex A). These properties are compared with control rings subjected to the same procedures using distilled water instead of the test substance.

For the inflation test, the inflated sections of the condom are exposed to the test substance and then heated to body temperature. They are then subjected to the inflation test as specified in the standards “ISO 4074 Natural rubber latex male condoms - Requirements and test methods” or “ISO 23409 Male condoms - Requirements and test methods for condoms made of synthetic materials”. The results are compared with control condoms subjected to the same test using distilled water instead of the test substance.

The equipment used in these tests includes:

• Environmental chamber or oven capable of maintaining 40 degrees plus/minus 2 degrees.
• Sample containers for blow-up testing can hold a condom and seal off volatile components of the test substance, preventing them from escaping into the atmosphere (excess space in the container should be kept to a minimum).
• Sample containers for tensile testing are capable of holding a tensile sample and are capable of isolating volatile components of the test material from escaping into the atmosphere (excess space in the container should be kept to a minimum).
• Tensile testing machine and cylinder grips capable of testing ring specimens in accordance with Annex A.
• Ring cutting die, mechanical press and replaceable cutting surface for cutting ring samples from condoms in accordance with Annex A.
• Holders suitable for holding ring samples while they are coated with the test substance.
• A soft paintbrush suitable for spreading the test substance on the condom.
• Cylindrical mounting pieces suitable for covering and storing condom samples for inflation testing.
• Blow tester suitable for testing condoms in accordance with Annex H of the ISO 4074 standard.
• Syringes or pipettes for dosing the tested substance.
• Small container or cylindrical container, approximately 30 mm in diameter, for storing the test substance and moistening the paintbrushes.

The negative control test should be performed first, followed immediately by swelling and tensile tests on the test substance.

Among the numerous tests, measurements, analyses and evaluation studies that our organization has carried out for businesses in various sectors, our organization also provides testing services defined in the standard “ISO 19671 Additional lubricants for male natural rubber latex condoms - Effect on condom strength” with its trained and expert staff and advanced technological equipment.