NBN ISO 11040-7:2024

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling (ISO 11040-7:2024)

ACTIVE

About this standard

Languages
English and French
Type
NBN
Standards committee
ISO/TC 76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use)
Status
ACTIVE
Publication date
23 October 2024
ICS Code
11.040.25 (Syringes, needles and catheters)
Withdrawn Date
Price
€ 124,00

Summary

< p class=" MsoBodyText" > < span lang=" EN-GB" > This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.< / span>


< p class=" MsoBodyText" > < span lang=" EN-GB" > 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.< / span>


< p class=" Note" > < span lang=" EN-GB" > NOTE 1< span style=" mso-tab-count: 1 " >         < / span> 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.< / span>


< p class=" Note" > < span lang=" EN-GB" > NOTE 2< span style=" mso-tab-count: 1 " >         < / span> ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.< / span>