标准摘要
[中文适用范围]： 本文件规定了 ISO 8536-1 中规定的输液瓶盖的形状、尺寸、材料、性能要求和标签。 尺寸要求不适用于带屏障涂层的瓶盖。 本文件中指定的封闭件仅供一次性使用。 注：医药产品在制造和储存过程中的效力、纯度、稳定性和安全性会受到内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 of closures for infusion bottles as specified in ISO 8536 - 1 . 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.
英文名称Infusion equipment for medical use — Part 2: Closures for infusion bottles