BS ISO 16038:2017

BS 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.


Cross References:
ISO 13485
ISO 14971
ISO 4074:2015
ISO 23409:2011 Ed 1
ISO 9000
ISO 2859-1
ISO 16142-1
ISO 10993-1
ISO 29941
ISO/TR 8550 (all parts)
ISO 29943-1
EN 455-3
ISO/IEC 17025
ASTM D3492
ISO 15223 (all parts)
ISO 14155
ISO 2859-10
ISO 11346
EN 980
ISO 10993-5
ISO 9000
ISO 9001
ASTM D6499-03
ISO 16037
ISO 10993-10
ASTM D5712 - 99
ISO 80000-1:2009 Ed 1


All current amendments available at time of purchase are included with the purchase of this document.