BS ISO 16038:2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality of design
5 Quality of manufacture
6 Quality in procurement
7 Quality in testing
8 Important parameters to consider when using
  ISO 4074 and ISO 23409
9 Sampling
Bibliography

Gives 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.

This document provides guidance on using ISO4074 and ISO23409 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 ISO4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.