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DIN ISO 11040-4:2025-04

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2024)

Fecha edición: 2025-04-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: 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.
Keywords: Anaesthetic equipment|Bottlings|Containers|Definitions|Design|Designations|Dimensions|Disposable|Equipment for single use|Filled|Glass cylinders|Glassware|Injection containers|Injection preparations|Marking|Materials|Medical devices|Medical instruments|Packages|Parenteral infusion equipment|Performance requirements|Quality|Single use syringes|Specification (approval)|Syringe bodies|Syringes|Testing
ICS: 11.040.25 - Jeringuillas, agujas y catéteres
CTN:

Equivalencia Internacional

Idéntica ISO 11040-4:2024

Reemplazo Normas

Reemplaza a DIN ISO 11040-4:2017-07

Reemplaza a DIN ISO 11040-4:2023-05

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