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Normas DIN – AENOR
DIN EN ISO 11608-5:2020-05

DIN EN ISO 11608-5:2020-05

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2020); German and English version prEN ISO 11608-5:2020 / Note: Date of issue 2020-03-27*Intended as replacement for DIN EN ISO 11608-5 (2013-01).

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2020); Version allemande et anglaise prEN ISO 11608-5:2020 / Attention: Date de parution 2020-03-27*Prévu pour remplacer DIN EN ISO 11608-5 (2013-01).

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2020); Deutsche und Englische Fassung prEN ISO 11608-5:2020 / Achtung: Erscheinungsdatum 2020-03-27*Vorgesehen als Ersatz für DIN EN ISO 11608-5 (2013-01).

Fecha:
2020-05 /Active
Equivalencias internacionales:

ISO/DIS 11608-5 (2020-02)

prEN ISO 11608-5 (2020-02)

Resumen:
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
Keywords:
Automatic, Automation, Cannulas, Data of the manufacturer, Definitions, Designations, Dosage, Drug administration, Drugs, Hypodermic needles, Injection instruments, Injection syringes, Injectors, Instructions for use, Medical devices, Medical equipment, Medical technology, Medicine, Needles, Performance requirements, Replaceability, Specification (approval), Testing, User information
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