DIN Standards Committee Heating and Ventilation Technology and their Safety
DIN ISO 11040-4
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
Vorgefüllte Spritzen - Teil 4: Spritzenzylinder aus Glas für Injektionspräparate und sterilisierte und vormontierte Spritzen zur Abfüllung (ISO 11040-4:2015)
Overview
This part of ISO 11040 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. This part of ISO 11040 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 this part of ISO 11040 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040. Based on the diameter of the prefilled syringes, appropriate components, such as rubber plungers, tip caps, needle shields, and other closure systems can also be standardized. In conjunction with the right sealing components, they offer a system for (parenteral) injectable use. The producers of filling machines can apply this part of ISO 11040 to achieve a degree of standardization in the equipment of the machines.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-04 AA - Packaging systems for loading and application of medical devices
Responsible international committee
ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
