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ISO 11040-4:2024

Prefilled syringes — Part 4: Glass barrels for injectables and 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 materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
—     tubing-glass barrels (single-chamber design) for injection preparations, and
—     sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE            National or regional regulations such as Ph.Eur., USP, or JP can apply.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11040-4:2015

NOW

PUBLISHED
ISO 11040-4:2024
60.60 Standard published
Jun 3, 2024