橡胶避孕套.关于天然橡胶胶乳避孕套质量管理的ISO 4047的使用指南

[中文适用范围]： 本文件提供了使用 ISO 4074 和 ISO 23409 的指南，并解决了安全套开发、制造、质量验证和采购过程中需要考虑的质量问题。 它涵盖了安全套设计、制造和交付的质量管理体系的各个方面，重点是性能、安全性和可靠性。 男用避孕套要么基本上由天然橡胶乳胶制成，在这种情况下，橡胶乳胶的要求适用，在这种情况下，ISO 23409 的要求适用。 本文件概述了适用于两种类型避孕套的方面，并在适当情况下进行了具体说明。 [外文原描述]： 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.