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Normas DIN – AENOR
DIN ISO 11040-4:2017-07

DIN ISO 11040-4:2017-07

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)

Seringues préremplies - Partie 4: Cylindres en verre pour produits injectables et seringues pré-assemblées stérilisées préremplissables (ISO 11040-4:2015)

Vorgefüllte Spritzen - Teil 4: Spritzenzylinder aus Glas für Injektionspräparate und sterilisierte und vormontierte Spritzen zur Abfüllung (ISO 11040-4:2015)

Fecha:
2017-07 /Active
Equivalencias internacionales:

ISO 11040-4 (2015-04)

Relación con otras normas DIN:
Resumen:
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.
Keywords:
Anaesthetic equipment, 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, Single use syringes, Specification (approval), Syringe bodies, Syringes, Testing
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