标准编号：ISO 11040-7:2015
中文名称：预灌封注射器 第7部分：消毒未装配填补注射器用包装
英文名称：Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
发布日期：2015-04
标准范围
This part of ISO 11040 specifies the packaging system that is used to deliver sterilized subassembledsyringes ready for filling in tubs and nests.Downstream processes (processes after filling such as in house/outside transport, reprocessing) canresult in specific requirements on the packaging system used to deliver sterilized subassembled syringesready for filling. However, these requirements are not within the scope of this part of ISO 11040.NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels forinjectables 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.
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