ISO’s work on condoms is carried out by ISO technical committee ISO/TC 157 on non-systemic contraceptives and STI barrier prophylactics. The standards it develops aim to ensure that condoms fit the penis properly, are free from holes, have adequate physical strength so as not to break during use, are correctly packaged for protection during storage and are correctly labeled.
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.
A key standard is ISO 4074:2002, Natural rubber latex condoms – Requirements and test methods, which provides the basis for much of the world’s trade in condoms. ISO 4074 is widely used by procurement agencies and HIV prevention and family planning agencies, and is referenced extensively by the World Health Organization in its purchasing specifications for condoms.
“Over the past decade, manufacturers of latex condoms have continued to make product improvements based on research and development findings, and on changes in ISO 4074, which is used in buyer’s purchasing specifications,” explains Dr. Eng Long Ong, Chair of ISO/TC 157, in an article on the subject published in ISO Focus magazine.
He adds that part of its success relies on the involvement of all key stakeholders, “Given the need to protect public health and safety, medical products are subject to stringent regulations. Condom manufacturers must ensure that their products meet regulatory requirements for efficacy, quality and suitability. Regulators include the US Food and Drug Administration, the European Commission and the procurement specifications of donor agencies providing free or low cost condoms. The involvement of regulatory agencies in the work of ISO/TC 157 is essential.”
ISO Secretary-General Rob Steele comments, “Millions of people have died as a result of AIDS, and millions more continue to live with HIV. One step for tackling this epidemic is giving people access to information about how to prevent contagion. But another equally important step is ensuring that people can rely on this information. If condoms are to be effective tools for responding to the epidemic, we must make sure that low quality products do not enter the market. ISO standards provide requirements based on internationally agreed levels of performance, which are available to all countries around the world. By complying with ISO standards, manufacturers can demonstrate to consumers and regulators that their products are fit for use.”
World AIDS Day is organized annually on 1 December by the World AIDS Campaign to raise awareness about the epidemic, honour those who have died, draw attention to key issues for a successful response and inspire positive action. This year, the theme of the event is “Universal access and human rights.” UN Secretary-General Ban Ki-moon has warned that many countries are seeing reduced access to essential HIV information, prevention tools, treatments and services, and has emphasized the important need to uphold human rights as part of the response to tackling the epidemic.
- Non-systemic contraceptives and STI barrier prophylactics
- ISO 4074:2002 [Withdrawn]Natural latex rubber condomsRequirements and test methods