ISO 8362-2:2024 注射容器及附件 第2部分：注射小瓶用瓶塞

标准编号：ISO 8362-2:2024

中文名称：注射容器及附件 第2部分：注射小瓶用瓶塞

英文名称：Injection containers and accessories — Part 2: Closures for injection vials

发布日期：2024-03

标准范围

本文件规定了ISO所涵盖的注射小瓶瓶盖的形状、尺寸、材料、性能要求和标签？8362-1和ISO？8362-4.尺寸要求不适用于带阻隔涂层的封闭件。本文件中规定的密封件仅供一次性使用。笔记？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初级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.

标准预览图