ISO-16038 › 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.
To find similar documents by classification:
11.200 (Birth control. Mechanical contraceptives)
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Document Number
ISO 16038:2017
Revision Level
2ND EDITION
Status
Current
Publication Date
Nov. 1, 2017
Committee Number
ISO/TC 157