You may be wondering : How reliable are condoms ? How should they be stored ? How long do they last before they expire ? How does one use them safely ? Are they regulated ? These and other questions are being addressed by ISO technical committee ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics, which covers all mechanical contraceptives, including male and female condoms, intra-uterine devices (IUDs) and rubber diaphragms.
The committee’s most important standard in terms of market size and use is ISO 4074:2002, Natural latex rubber condoms - Requirements and test methods. For those allergic or sensitive to natural rubber latex, help is at hand in the form of ISO 23409:2011 which defines the requirements and test methods for male condoms made from synthetic materials.
Other key standards address such areas as:
- Female condoms (ISO 25841:2011)
- Copper-bearing contraceptive IUDs (ISO 7439:2011)
- Reusable natural and silicone rubber contraceptive diaphragms (ISO 8009:2004)
- Prophylactic dams (ISO 29942:2011)
Products compliant with these ISO standards dominate the world market for mechanical contraceptives, particularly condoms.
As medical devices, mechanical contraceptives require regulation in terms of market approval, efficacy, quality and suitability for their intended purpose. This is why bodies such as the World Health Organization (WHO), the United Nations Population Fund, the global-health-solutions NGO PATH, Consumers International and social marketing agencies all participate in ISO/TC 157’s work.
In fact, the International Standards developed by this technical committee are used by procurement agencies and social marketers, and are referred to extensively by WHO in its purchasing specification for male and female condoms.
ISO will continue to develop and refine standards in line with the development of the industry, as well as produce appropriate guidance documents on clinical trials for copper IUDs, female condoms and male synthetic condoms.