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Standard ÖNORM EN ISO 11608-3 1.1.2024 preview

ÖNORM EN ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)

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STANDARD published on 1.1.2024


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The information about the standard:

Designation standards: ÖNORM EN ISO 11608-3
Publication date standards: 1.1.2024
SKU: NS-1162675
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

Syringes, needles and catheters

Annotation of standard text ÖNORM EN ISO 11608-3 :

Dieses Dokument legt Anforderungen und Prüfverfahren für die Designverifizierung von Behältern und integrierten Flüssigkeitsbahnen fest, die mit kanülenbasierten Injektionssystemen (NISs, en: needle-based injection systems) nach ISO 11608-1 verwendet werden. Es ist anwendbar auf Einzeldosis- und Mehrfachdosisbehälter, die entweder vom Hersteller (Primärbehälter) oder vom Endanwender befüllt (Vorratsbehälter) (z. B. Karpulen, Spritzen) werden, sowie für Flüssigkeitsbahnen, die am Ort der Herstellung in das NIS integriert werden. Dieses Dokument ist auch anzuwenden für vorgefüllte Spritzen (siehe ISO 11040-8), wenn sie zusammen mit einem NIS verwendet werden (siehe auch den Anwendungsbereich von ISO 11608-1:2022). Dieses Dokument ist für folgende Produkte nicht anzuwenden: - sterile Subkutankanülen; - sterile Injektionsspritzen; - sterile Spritzen zum Einmalgebrauch, mit oder ohne Kanüle, für Insulin; - Behälter, die mehrere Male befüllt werden können; - zum zahnärztlichen Gebrauch vorgesehene Behälter; - Katheter oder Infusionssets, die vom Benutzer angebracht oder separat zusammengesetzt werden.

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