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ISO 11040-4:2015

Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

Publication date:   Apr 2, 2015

General information

90.92 Standard to be revised   Nov 25, 2020

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

ISO 11040-4:2015 applies to

tubing-glass barrels (single-chamber design) for injection preparations, and
sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11040-4:2007

NOW

PUBLISHED
ISO 11040-4:2015
90.92 Standard to be revised
Nov 25, 2020

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11040-4:2015/Amd 1:2020

REVISED BY

IN_DEVELOPMENT
ISO/FDIS 11040-4