ISO 16038:2017 男性避孕套 避孕套质量管理的ISO 4047和ISO 23409的使用指南

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

ISO 16038:2017提供了使用ISO 4074和ISO 23409的指南，并解决了避孕套开发、制造、质量验证和采购过程中需要考虑的质量问题。它包括安全套设计、制造和交付的质量管理体系，强调性能、安全性和可靠性。男用安全套要么基本上由天然胶乳制成，在这种情况下，ISO 4074的要求适用；要么由合成材料和/或合成材料与天然胶乳的混合物制成，在这种情况下，ISO 23409的要求适用。本文件概述了适用于这两种安全套的方面，并在适当情况下进行了具体说明。

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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