ISO 8362-2:2024

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

General information

60.60 Standard published   Mar 21, 2024

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

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WITHDRAWN
ISO 8362-2:2015

WITHDRAWN
ISO 8362-2:2015/Amd 1:2022

NOW

PUBLISHED
ISO 8362-2:2024
60.60 Standard published
Mar 21, 2024