ISO 8871-5:2025Published

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing

Éléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique — Partie 5: Exigences fonctionnelles et essais

Abstract / 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

Replaces

ISO 8871-5:2016WithdrawnElastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testingInternational Standard · Published 13 Oct 2016 · ISO/TC 76