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Normas DIN – AENOR
DIN EN ISO 11608-3:2011-01

DIN EN ISO 11608-3:2011-01

Needle-based injection systems - Requirements and test methods - Part 3: Finished containers (ISO/DIS 11608-3:2010); German version prEN ISO 11608-3:2010 / Note: Date of issue 2011-01-24

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 3: Réservoirs finis (ISO/DIS 11608-3:2010); Version allemande prEN ISO 11608-3:2010 / Attention: Date de parution 2011-01-24

Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 3: Fertigbehälter (ISO/DIS 11608-3:2010); Deutsche Fassung prEN ISO 11608-3:2010 / Achtung: Erscheinungsdatum 2011-01-24

Fecha Anulación:
2013-01 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11608-3 (2010-12)

prEN ISO 11608-3 (2010-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11608-3:2013-01

Resumen:
This part of ISO 11608 specifies the functional and design considerations for containers to be used with Needle-based Injection Systems (NIS) which fulfil the specifications of ISO 11608-1. Containers covered in this standard include single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end user integrated in the NIS or assembled with the NIS at the time of use.
Keywords:
Carpules, Containers, Cylinders, Data of the manufacturer, Definitions, Design, Designations, Dimensions, Dosage, Drug administration, Injection instruments, Injection syringes, Injectors, Insulin, Marking, Mathematical calculations, Medical devices, Medical equipment, Medical products, Medical technology, Pen-injectors, Precision, Replaceability, Specification (approval), Technical data sheets, Testing, User information
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