prBAS EN ISO 8362-2:2025
Injection containers and accessories - Part 2: Closures for injection vials
General information
Status:Project
Number of pages:13
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:08.10.2024
Forseen date for next stage code:09.10.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.20, Transfusion, infusion and injection equipment
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN ISO 8362-2:2024, identical
ISO 8362-2:2024, identical
Relation to BAS standards
Work material
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