标准摘要
[中文适用范围]： 本文件规定了输液瓶封盖的形状、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）。尺寸要求不适用于阻隔涂层封盖。本文件中规定的封盖仅供一次性使用。注意：药品在制造和储存过程中的效力、纯度、稳定性和安全性可能受到初级包装的性质和性能的强烈影响。 [外文原描述]： 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 be strongly affected by the nature and performance of the primary packaging.
英文名称Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles