标准摘要
[中文适用范围]： 本文件规定了由ISO 8362-1和ISO 8362-4涵盖的注射安瓿封口的形状、尺寸、材料、性能要求和标签。封口的尺寸要求不适用于屏障涂层封口。根据本文件规定的封口仅用于单次使用。注：药品在制造和储存过程中，其效力、纯净度、稳定性和安全性会强烈受到主要包装性质和性能的影响。 [外文原描述]： 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.
英文名称Injection containers and accessories — Part 2: Closures for injection vials