ISO 8536-6:2016 医用输液器具 第6部分：冷冻干燥用关闭输液瓶

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

ISO 8536-6:2016规定了与药物和生物材料冷冻干燥（或冻干）相关的输液瓶封口类型的形状、尺寸、材料、性能要求和标签，如ISO 8536-1所述。尺寸要求不适用于涂有屏障的封闭件。本文件中规定的封盖仅供一次性使用。

ISO 8536-6:2016 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.

标准预览图