ISO 16038:2017

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

Published By	Publication Date	Number of Pages
ISO	2017-11	22

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Categories: 11.200 - Birth control. Mechanical contraceptives, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2017-11
Pages Count	22
Language	English
Edition	2
File Size	378.9 KB
ICS Codes	11.200 - Birth control. Mechanical contraceptives

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ISO 16038:2017

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