90.92 Standard to be revised Sep 27, 2024
ISO
ISO/TC 157 Non-systemic contraceptives and STI barrier prophylactics
International Standard
11.200 Birth control. Mechanical contraceptives
ISO 16038:2017 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.
WITHDRAWN
ISO 16038:2005
PUBLISHED
ISO 16038:2017
90.92
Standard to be revised
Sep 27, 2024
IN_DEVELOPMENT
ISO/AWI 16038