BS ISO 11040-4:2015+A1:2020 - Page 2

Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling | Status: Superseded, Withdrawn

1 Scope 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.

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 part of ISO 11040.