标准编号：ISO 8536-6:2016
中文名称：医用输液器具 第6部分：冷冻干燥用关闭输液瓶
英文名称：Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
发布日期：2016-12
标准范围
This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this document are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
标准预览图
立即下载标准文件