DANSK DSF/ISO/DIS 11040-4 PDF

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.