标准摘要
[中文适用范围]： 本文件规定了医用笔式注射器密封件的形状、尺寸、材料、性能要求和标签。 注：医药产品在制造和储存过程中的功效、纯度、稳定性和安全性可能会受到内包装的性质和性能的显着影响。 [外文原描述]： This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
英文名称Pen systems — Part 3: Seals for pen-injectors for medical use