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ILNAS-EN ISO 8536-13:2016 Edition 10/2016
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
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  • 21.2 / copy
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Abstract

ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    25/06/2015   date of ratification (dor)    17/09/2016
end of the vote on the project    25/09/2015   date of anouncement (doa)    31/01/2017
start of the vote on the final project    23/06/2016   date of publication (dop)    30/04/2017
end of the vote on the final project    16/08/2016   date of withdrawal (dow)    30/04/2017


Publication Official Journal
of the Grand-Duchy of Luxembourg
18/11/2016
Reference Mémorial A N° 230

Relations

Evolutions
prEN ISO 8536-13

Relations to international standards
ISO 8536-13 
ISO 8536-13:2016 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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