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ILNAS-EN ISO 8871-3:2004 Edition 05/2004
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)
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Abstract

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project      date of ratification (dor)    01/04/2004
end of the vote on the project      date of anouncement (doa)    31/08/2004
start of the vote on the final project    14/08/2003   date of publication (dop)    30/11/2004
end of the vote on the final project    14/02/2004   date of withdrawal (dow)    30/11/2004


Publication Official Journal
of the Grand-Duchy of Luxembourg
04/02/2005
Reference

Relations

Evolutions
ILNAS-EN ISO 8871-3:2004/A1:2019

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

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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