Overview

This document has been prepared by Technical Committee ISO/TC 157 "Non-systemic contraceptives and STI barrier prophylactics" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" the secretariat of which is held by DIN. The responsible German body is Working Committee NA 063-01-04 AA "Kondome und Intrauterinpessare" ("Condoms and intrauterine devices") at the DIN Standards Committee Medicine. This standard specifies requirements and test methods to be applied for male condoms made from natural rubber latex, and currently is submitted to the second parallel enquiry. Numerous clinical studies have confirmed that male latex condoms are effective in helping to prevent pregnancy and reduce the risk of transmission of most STIs including HIV. In order to help ensure that condoms are effective, it is essential that condoms have the following characteristics: fit the penis properly, are free from holes, have adequate physical strength, are correctly packaged to protect them during storage, and are correctly labelled to facilitate their use. All these issues are addressed in this International Standard.

Document: references other documents

Responsible national committee

NA 176-04-10 AA - Condoms and intrauterine devices  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 157/WG 11 - Packaging integrity