预填充注射器第4部分:可注射的玻璃管和可填充的无菌分装注射器

[中文适用范围]： 本文件规定了材料、尺寸、质量和性能要求以及相关测试方法。本文件还规定了无菌分装注射器的组成部分。本文件适用于 — 用于注射制剂的管式玻璃筒（单室设计），以及 — 无菌分装注射器。根据本文件，玻璃筒和无菌分装注射器仅供一次性使用。分装注射器的组成部件（如柱塞塞和柱塞杆）不在本文件的范围内。注意：可能适用国家或地区法规，如欧洲药典、美国药典或日本药典。 [外文原描述]： This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This document also specifies components that are part of the sterilized subassembled syringe ready for filling. This document is applicable to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document. NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.