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ILNAS-EN ISO 8536-4:2013 Edition 02/2013
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)
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  • 34 / copy
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Abstract

ISO 8536‑4:2010 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 ISO 8536‑4:2010 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. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

Status

Standard - Superseded

Origin

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

Implementation

start of the vote on the project      date of ratification (dor)    08/01/2013
end of the vote on the project      date of anouncement (doa)    31/05/2013
start of the vote on the final project    28/04/2014   date of publication (dop)    31/08/2013
end of the vote on the final project    29/09/2014   date of withdrawal (dow)    31/08/2013


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/06/2013
Reference

Relations

Evolutions
ILNAS-EN ISO 8536-4:2020
ILNAS-EN ISO 8536-4:2013/A1:2013

Relations to older standards
ILNAS-EN ISO 8536-4:2010

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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