NBN ISO 16038:2021

This document provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be
considered during the development, manufacture, quality verification and procurement of condoms. It
encompasses the aspects of quality management systems in the design, manufacture and delivery of
condoms with an emphasis on performance, safety and reliability.
Male condoms are either made from essentially natural rubber latex, in which case the requirements of
ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural
rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the
aspects applicable to both types of condoms with specific clarifications where appropriate.