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ISO 11040-4:2024

Current Revision

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

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11040
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 76
Publish Date Document Id Type View
Not Available ISO 11040-4:2024 Revision
Not Available ISO 11040-4:2015 Revision