ISO 8536-6:2009 医用输液器具 第6部分：输液瓶用冷冻干燥塞

标准编号：ISO 8536-6:2009

中文名称：医用输液器具 第6部分：输液瓶用冷冻干燥塞

英文名称：Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

发布日期：2009-11

标准范围

ISO 8536-6:2009规定了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，用于药物和生物材料的冷冻干燥（或冻干）。尺寸要求不适用于涂有屏障的封闭件。ISO 8536-6:2009中规定的封盖仅用于一次性使用。

ISO 8536-6:2009 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are 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 ISO 8536-6:2009 are intended for single use only.

标准预览图