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ISO 16038:2017

Current Date published:

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

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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Related Information

Similar Standards

  • BS EN ISO 4074:2015

    Natural rubber latex male condoms. Requirements and test methods

  • BS EN ISO 4074:2015 - TC

    Tracked Changes. Natural rubber latex male condoms. Requirements and test methods

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    Copper-bearing contraceptive intrauterine devices. Requirements and tests

  • BS ISO 11249:2018

    Copper-bearing intrauterine contraceptive devices. Guidance on the design, execution, analysis and interpretation of clinical studies

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ISO 16038:2017

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