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ILNAS-EN ISO 8536-4:2020 Edition 01/2020
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)
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Abstract

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    15/03/2018   date of ratification (dor)    17/10/2019
end of the vote on the project    07/06/2018   date of anouncement (doa)    30/04/2020
start of the vote on the final project    23/05/2019   date of publication (dop)    31/07/2020
end of the vote on the final project    18/07/2019   date of withdrawal (dow)    31/07/2020


Publication Official Journal
of the Grand-Duchy of Luxembourg
27/08/2020
Reference Mémorial A N° 711

Relations

Relations to older standards
ILNAS-EN ISO 8536-4:2013
ILNAS-EN ISO 8536-4:2013/A1:2013

Relations to international standards
ISO 8536-4 
ISO 8536-4:2019 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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