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ILNAS-EN ISO 8536-5:2013 Edition 02/2013
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)
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Abstract

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Status

Standard - Active

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

Relations to older standards
ILNAS-EN ISO 8536-5:2011

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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