EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

Publication date:   May 16, 2024

General information

60.60 Standard published   Apr 3, 2024

CEN

CEN/BT

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE            The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8362-2:2015

WITHDRAWN
EN ISO 8362-2:2015/A1:2022

NOW

PUBLISHED
EN ISO 8362-2:2024
60.60 Standard published
Apr 3, 2024