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Normas DIN – AENOR
DIN EN ISO 11608-1:2014-02

DIN EN ISO 11608-1:2014-02

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/FDIS 11608-1:2014); German version Fassung FprEN ISO 11608-1:2014 / Note: Date of issue 2014-01-10

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 1: Systèmes d'injection à aiguille (ISO/ FDIS 11608-1:2014); Version allemande FprEN ISO 11608-1:2014 / Attention: Date de parution 2014-01-10

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme (ISO/FDIS 11608-1:2014); Deutsche Fassung FprEN ISO 11608-1:2014 / Achtung: Erscheinungsdatum 2014-01-10

Fecha Anulación:
2015-04 /Withdrawn
Equivalencias internacionales:

FprEN ISO 11608-1 (2014-07)

ISO/FDIS 11608-1 (2014-07)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11608-1:2015-04

Resumen:
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user. Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively. Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.
Keywords:
Cannulas, Containers, Data of the manufacturer, Definitions, Design, Designations, Dosage, Drug administration, Hypodermic needles, Injection instruments, Injection syringes, Injectors, Instructions for use, Marking, Medical devices, Medical equipment, Medical products, Medical technology, Needles, Packages, Pen-injectors, Performance requirements, Precision, Replaceability, Specification (approval), Testing, User information
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