本文件规定了ISO 8362-1和ISO 8362-4所涵盖的注射瓶封盖的形状、尺寸、材料、性能要求和标签。 尺寸要求不适用于涂有阻隔层的封闭件。 本文档中指定的封盖仅供一次性使用。 注:药品在生产和储存过程中的效力、纯度、稳定性和安全性会受到主要包装的性质和性能的强烈影响。

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. 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.