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ISO 16038:2017

Current Revision

Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 16038
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 157
Publish Date Document Id Type View
Not Available ISO 16038:2017 Revision