标准摘要
[中文适用范围]： 本文件规定了滴注玻璃瓶的设计、尺寸、材料和需求。滴注玻璃瓶适用于与药物直接接触的初级包装。 本文件适用于药房中使用的滴注玻璃瓶。与相应的封闭系统一起，它们用于包装非注射用药物制剂。 药物的效力、纯度、稳定性和安全性在其制造和储存过程中会受到初级包装的性质和性能的强烈影响。 [外文原描述]： ISO 11418-1:2016 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
英文名称Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing glass bottles