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ILNAS-EN ISO 1135-4:2012 Edition 03/2012
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)
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Abstract

ISO 1135-4:2011 specifies requirements for single-use transfusion 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 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Status

Standard - Superseded

Origin

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

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project      date of ratification (dor)    29/02/2012
end of the vote on the project      date of anouncement (doa)    30/06/2012
start of the vote on the final project    03/11/2011   date of publication (dop)    30/09/2012
end of the vote on the final project    03/02/2012   date of withdrawal (dow)    30/09/2012


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

Relations

Evolutions
ILNAS-EN ISO 1135-5:2015
ILNAS-EN ISO 1135-4:2015

Relations to older standards
ILNAS-EN ISO 1135-4:2011

Relations to international standards
ISO 1135-4 
ISO 1135-4:2012 
ISO 1135-4:2012 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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