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ILNAS-EN ISO 8871-5:2016 Edition 11/2016
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
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Abstract

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

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)    06/08/2016
end of the vote on the project    25/09/2015   date of anouncement (doa)    28/02/2017
start of the vote on the final project    05/05/2016   date of publication (dop)    31/05/2017
end of the vote on the final project    06/07/2016   date of withdrawal (dow)    31/05/2017


Publication Official Journal
of the Grand-Duchy of Luxembourg
03/02/2017
Reference Mémorial A N° 146

Relations

Evolutions
prEN ISO 8871-5

Relations to older standards
ILNAS-EN ISO 8871-5:2014

Relations to international standards
ISO 8871-5 
ISO 8871-5 
ISO 8871-5:2016 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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