Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2024)
Abstract
This document 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 document 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 document are intended for single use only. Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are out of scope. NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Where relevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this document.
Begin
2022-05-16
Planned document number
DIN ISO 11040-4
Project number
06302148
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
draft standard
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO/DIS 11040-4:2023); Text in German and English
2023-05
Order from DIN Media
