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Glavni meni

ISO 11040-4:2024

Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
3. 6. 2024.

Опште информације

60.60     3. 6. 2024.

ISO

ISO/TC 76

Međunarodni standard

11.040.25  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11040-4:2015

POVUČEN
ISO 11040-4:2015/Amd 1:2020

TRENUTNO

OBJAVLJEN
ISO 11040-4:2024
60.60 Standard objavljen
3. 6. 2024.