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ILNAS-EN ISO 1135-4:2015 Edition 12/2015
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
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  • 34.20 / copy
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Abstract

ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    03/10/2013   date of ratification (dor)    24/07/2015
end of the vote on the project    03/03/2014   date of anouncement (doa)    31/03/2016
start of the vote on the final project    23/04/2015   date of publication (dop)    30/06/2016
end of the vote on the final project    23/06/2015   date of withdrawal (dow)    30/06/2016


Publication Official Journal
of the Grand-Duchy of Luxembourg
03/05/2016
Reference Mémorial A N° 77

Relations

Evolutions

Relations to older standards
ILNAS-EN ISO 1135-4:2012

Relations to international standards
ISO 1135-4 
ISO 1135-4 
ISO 1135-4 
ISO 1135-4:2015 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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