全文获取ISO 11040-7－2024【原文+翻译】Prefilled syringes

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ISO 11040-7－2024当前有效最新版本
全文获取ISO 11040-7－2024【原文+翻译】
Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling
STANDARD by International Organization for Standardization , 06/01/2024
Description：
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.

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