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EN ISO 8871-3:2004

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

Publication date:   Sep 25, 2006

General information

60.60 Standard published   May 26, 2004

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

Buying

Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8871:1997

WITHDRAWN
EN ISO 8871:1997/A1:1999

NOW

PUBLISHED
EN ISO 8871-3:2004
60.60 Standard published
May 26, 2004

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 8871-3:2004/A1:2019

Relations

Adopted from ISO 8871-3:2003 IDENTICAL