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ISO 11040-7:2024

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Publication date:   Jun 3, 2024

General information

60.60 Standard published   Jun 3, 2024

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.25   Syringes, needles and catheters

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11040-7:2015

NOW

PUBLISHED
ISO 11040-7:2024
60.60 Standard published
Jun 3, 2024