标准编号：ISO 16038:2017
中文名称：男性避孕套 避孕套质量管理的ISO 4047和ISO 23409的使用指南
英文名称：Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
发布日期：2017-11
标准范围
This document 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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