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EN ISO 8871-5:2025

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)

Publication date:   May 19, 2025

General information

60.60   Standard published   Mar 26, 2025

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.
NOTE            Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8871-5:2016

NOW

PUBLISHED
EN ISO 8871-5:2025
60.60 Standard published
Mar 26, 2025