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.
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsPublished
Will be replaced byUnder development