Alcance
ISO 11040-4:2015 applies totubing-glass barrels (single-chamber design) for injection preparations, andsterilized 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.