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:药品在生产和储存期间的效力、纯度、稳定性和安全性可能会受到初级包装的性质和性能的显著影响。交叉引用:ISO 7864ISO 8871-4ISO 48-4ISO 13926-1ISO 11608-3ISO 8872ISO 8871-1ISO 3302（所有部分）ISO 13926-2ISO 8871-5:2016ISO 48-2ISO 2230ISO 15378购买本文件时提供的所有当前修订版均包括在内。

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.Cross References:ISO 7864ISO 8871-4ISO 48-4ISO 13926-1ISO 11608-3ISO 8872ISO 8871-1ISO 3302 (all parts)ISO 13926-2ISO 8871-5:2016ISO 48-2ISO 2230ISO 15378All current amendments available at time of purchase are included with the purchase of this document.