EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Publication date:   Sep 25, 2006

General information

60.60   Standard published   Jun 15, 2006

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8871:1997

WITHDRAWN
EN ISO 8871:1997/A1:1999

NOW

PUBLISHED
EN ISO 8871-4:2006
60.60 Standard published
Jun 15, 2006

REVISED BY

IN_DEVELOPMENT
prEN ISO 8871-4 rev