标准摘要
[中文适用范围]： 本文件规定了一种包装系统，用于将准备灌装的灭菌分装注射器运送到桶和巢中。下游工艺（灌装后的工艺，如室内/室外运输、再加工）可能对用于运送准备灌装的灭菌分装注射器的包装系统提出特定要求。但是，这些要求不在本文件的范围内。注 1 ISO 11040-4、ISO 11040-5 和 ISO 11040-6 规定了用于注射剂的玻璃筒和准备灌装的灭菌分装注射器、柱塞塞和塑料筒。注 2 ISO 11607-2 规定了医疗器械密封和包装工艺的验证要求。 [外文原描述]： This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document. NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6. NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.
英文名称Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling