Testing of Male condoms as per ISO 23409

A condom is an instrument that acts as a barrier between the private parts of a man and a woman during coitus. The purpose of the instrument is to prevent any kind of discharge from one partner to touch or enter the body of the other. Condoms are used to prevent pregnancy and the transfer of sexually transmitted diseases.

Durability of Condoms

Male condoms are made either from latex or from other materials such as polyurethane and polyisoprene (or lambskin). Latex condoms are thin and strong, hence are more preferred over lambskin condoms. Latex condoms are a blend of synthetic materials and rubber latex. The blend is strong enough to endure friction without breaking and thin enough to not cause any obstructions. The composition and manufacturing process of this blend has been clearly defined and when it is prepared according to that, the final product is extremely durable. But sometimes certain defects can pave the way into the manufacturing process. The result of faulty production is likely to be a defective product. In an industry like this faulty products can have serious repercussions on the manufacturing companies. Hence, the need for testing. Testing can ensure that their products conform to pre-determined standards and are durable.

ISO 23409 Standard for Condoms

The standards that the testing companies use to determine the quality of a condom are set by the ISO. International Standardization Organization (ISO) is a standardization body that prescribes standards and regulations for condom manufacturing companies to follow. These regulations are categorized under ISO 23409. These regulations are strict and they ensure the production of high-quality products. The condoms which are manufactured according to ISO 23409 are 98 per cent safe.

Testing of condoms

Testing companies test the condoms on various parameters that determine their quality and hence their utility. Following are some of the parameters –

• Test of condom sheath and retention mechanism

Each condom has a sheath and retention mechanism which is primary to the function of the instrument. The mechanism has to be specified and evaluated according to ISO, to ensure that there are no glitches that can undermine the efficiency of the product.

• Test of lubricant

The lubricant used in the condom has to be tested to determine if it is fit for its purpose. The tests determine its manufacturing date, expiry date and suitability for use.

• Test of dimensions

Each condom has specified dimensions like length and radius. These dimensions should be tested to ensure that they perform efficiently.

• Test of volume and pressure

Condoms are tested for the maximum volume and pressure they can withhold.

• Test for holes

No condom should have any physical damage (such as holes) or any other forms of wreckage. This can cause a condom to fail.

• Test for stability and shelf life

Stability and shelf life are tested according to ISO to ensure that condoms are fit for use for the entire period between the date of manufacturing and the date of expiry.

•  Test for Bio-Compatibility

The Bio-compatibility of a condom determines if they are safe for human use. Tests are done to check the compatibility of the genital tissues and material used in making condoms.

Testing these parameters according to ISO 23409 ensure that condoms are of superior quality.

• What is a condom?