SSH ISO 11040-4:2015

Shiringa të mbushura paraprakisht - Pjesa 4: Cilindra qelqi për injeksione dhe shiringa të montuara paraprakisht të sterilizuara gati për mbushje

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

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.