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Normas DIN – AENOR
DIN ISO 11040-6:2020-10

DIN ISO 11040-6:2020-10

Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019); Text in German and English / Note: Date of issue 2020-09-11

Seringues préremplies - Partie 6: Cylindres en plastique pour produits injectables et seringues pré-assemblées stérilisées préremplissables (ISO 11040-6:2019); Texte en allemand et anglais / Attention: Date de parution 2020-09-11

Vorgefüllte Spritzen - Teil 6: Spritzenzylinder aus Kunststoff für Injektionspräparate und sterilisierte, für die Abfüllung vorgefertigte Spritzen (ISO 11040-6:2019); Text Deutsch und Englisch / Achtung: Erscheinungsdatum 2020-09-11

Fecha:
2020-10 /Active
Equivalencias internacionales:

ISO 11040-6 (2019-01)

Relación con otras normas DIN:

Reemplazada por: DIN ISO 11040-6:2021-05

Resumen:
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer 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 and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.
Keywords:
Anaesthesiology, Biological characteristics, Chemical properties, Containers, Definitions, Design, Dimensions, Disposable, Equipment for single use, Injection instruments, Injection syringes, Injections, Marking, Materials, Medical instruments, Medical sciences, Medical technology, Packages, Parenteral infusion equipment, Physical properties, Plastic containers, Plastics, Single use syringes, Syringe bodies, Syringes
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