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prSSH 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)

General information

40.20     Feb 9, 2026

40.60    May 11, 2026

DPS

DPS/KT 205

European Norm

11.040.20  

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

PUBLISHED
SSH EN ISO 8871-5:2016

NOW

IN_DEVELOPMENT
prSSH EN ISO 8871-5:2025
40.20 DIS ballot initiated: 12 weeks
Feb 9, 2026

Related project

Adopted from EN ISO 8871-5:2025 IDENTICAL

Adopted from ISO 8871-5:2025 IDENTICAL

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