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ILNAS-EN ISO 8536-14:2018 Edition 02/2018
Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
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  • 19.2 / copy
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Abstract

ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

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)    19/12/2017
end of the vote on the project    25/09/2015   date of anouncement (doa)    31/05/2018
start of the vote on the final project    23/06/2016   date of publication (dop)    31/08/2018
end of the vote on the final project    16/08/2016   date of withdrawal (dow)    28/02/2021


Publication Official Journal
of the Grand-Duchy of Luxembourg
21/03/2018
Reference Mémorial A N° 202

Relations

Relations to international standards
ISO 8536-14 
ISO 8536-14:2016 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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