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Injection containers and accessories — Part 2: Closures for injection vials 注射容器和附件第2部分:注射小瓶的封口
发布日期: 2024-03-21
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.

NOTEThe 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.

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归口单位: ISO/TC 76
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