标准摘要
[中文适用范围]: 本文件规定了仅限一次性使用的牙科局部麻醉剂药筒用密封件的形状、尺寸、材料、性能要求和标签。注:药品在生产和储存过程中,其效力、纯度、稳定性和安全性会受到主要包装材料性质和性能的显著影响。 [外文原描述]: This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. 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Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges