Condoms are highly effective in providing protection against HIV, that attacks the body’s immune system and can lead to AIDS, according to the World Health Organization (WHO). And to make sure that condoms indeed function in this capacity, they are manufactured and tested to the highest ISO standards to ensure that they don’t break or leak when used.
ISO’s work on condoms is carried out by technical committee ISO/TC 157 on non-systemic contraceptives and STI barrier prophylactics. The standards it develops aim to ensure that condoms fit properly, are free from holes, have adequate physical strength so as not to rip during use, are adequately packaged for protection during storage and are correctly labelled. They also give essential information for the condom user, including instructions for use.
For it to be effective, the quality of the condom is very important. Before any production, the raw material, the latex, already undergoes quality tests. Next, tests are carried out on random individual specimens from each batch. A batch typically represents 150 000 condoms under just one series number.
Condoms also protect from various viruses, not least hepatitis C, a liver-destroying disease. To minimize the risk of viral transmission, ISO/TC 157 has developed a new test procedure for confirming the barrier properties of materials.
“Manufacturers are required to confirm that these condoms are effective viral barriers,” explains Bill Potter from the ISO working group. He adds that the testing of condoms is done from three production lots during the validation stage for any new or modified products. Details of the tests are included in ISO 25841:2017 for female condoms (and the earlier 2011 and 2014 editions) and ISO 23409:2011 for male condoms made from synthetic materials.
Most of the products under the responsibility of ISO/TC 157 are classified as medical devices, and range from the single-use male condom to multiple-use female intra-uterine devices that provide long-term protection. These standards are being developed by ISO/TC 157, whose secretariat is currently held by DSM, the ISO member for Malaysia.
World AIDS Day is held on 1 December each year. It is an opportunity for people worldwide to unite in the fight against HIV, commemorate those who have passed on and celebrate how far we have come in conquering this deadly disease.
