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ILNAS-EN ISO 11608-5:2023 Edition 03/2023
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
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  • 36.2 / copy
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    17/11/2022   date of ratification (dor)    10/03/2023
end of the vote on the project    09/02/2023   date of anouncement (doa)    30/06/2023
start of the vote on the final project    01/07/2024   date of publication (dop)    30/09/2023
end of the vote on the final project    26/08/2024   date of withdrawal (dow)    30/09/2023


Publication Official Journal
of the Grand-Duchy of Luxembourg
08/09/2023
Reference Mémorial A N° 572

Relations

Relations to older standards
ILNAS-EN ISO 11608-5:2012

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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