Re-evaluation of data and requirements on condom shelf life

Condom quality is, in many countries, regulated through ISO (international standard) 4074 which prescribes a maximum shelf life of 5 years, and also a real time stability requirement to ensure the products are fit for use until the expiry date. The United Nations and other major public sector purchasers prescribe square packs made with aluminium foil. This article examines the history of, and available data on, the shelf life of condoms, and on how individual packs may affect that. It reviews data in the open literature, and that used in the development of the requirements in ISO 4074, and includes relevant data on the physical properties of condoms as a function of storage time. The change in properties is examined in the light of the 5 year shelf life limit, and the package materials and shape. The results indicate opportunities to relax the packaging and shelf life requirements on some of the products.