Active standard | Published: 06/12/2017

ISO 16038:2017-ed.2.0

Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
(Préservatifs masculins — Lignes directrices sur l’utilisation de la norme ISO 4074 et ISO 23409 sur le management de la qualité des préservatifs en latex de caoutchouc naturel et en matériau synthétiques)

Available languages: English

Available design: electronic design (pdf), Print design

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Detail information

Designation: ISO 16038:2017-ed.2.0

Publication date: 06/12/2017

Pages: 12

Country: International technical standard

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Anotation

Description / Abstract: 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.

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