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ILNAS-EN ISO 8871-4:2006 Edition 06/2006
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
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Abstract

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    14/04/2005   date of ratification (dor)    05/06/2006
end of the vote on the project    14/09/2005   date of anouncement (doa)    30/09/2006
start of the vote on the final project    02/03/2006   date of publication (dop)    31/12/2006
end of the vote on the final project    02/05/2006   date of withdrawal (dow)    31/12/2006


Publication Official Journal
of the Grand-Duchy of Luxembourg
27/07/2006
Reference

Relations

Relations to older standards
ILNAS-EN ISO 8871:1997/A1:1999
ILNAS-EN ISO 8871:1997

Relations to international standards
ISO/NP 8871-4 
ISO 8871-4:2006 
ISO 8871-4:2006 
ISO 8871-4:2006 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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