ISO 16038:2017 PDF

Scope: 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 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.

ISO 16038:2017 Referenced Document

ISO 13485 *， 2018-05-15 Update
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 23409:2011 Male condoms - Requirements and test methods for condoms made from synthetic materials
ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods
ISO 9000 Quality management systems - Fundamentals and vocabulary [French version]

2017 ISO 16038:2017 Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
2005 ISO 16038:2005 Rubber condoms - Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms