标准摘要
[中文适用范围]： 本文件规定了与安瓿配合使用且可被注射针头刺穿的瓶塞在功能参数方面的要求及试验方法。注：带刺尖接口的功能测试方法见ISO 8536-2、ISO 8536-6、ISO 8362-1和ISO 8362-4。 [外文原描述]： This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.
英文名称Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing