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EN ISO 8871-5:2016

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

Publication date:   Jan 18, 2017

General information

60.60 Standard published   Nov 23, 2016

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

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8871-5:2014

NOW

PUBLISHED
EN ISO 8871-5:2016
60.60 Standard published
Nov 23, 2016

REVISED BY

IN_DEVELOPMENT
prEN ISO 8871-5