BAS EN ISO 8362-2:2025
Injekcijski spremnici i dodatna oprema – Dio 2: Zatvarači za injekcijske bočice
Opće informacije
Status: Važeći
Broj strana: 10
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 18.06.2025
Tehnički komitet:
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 8362-2:2024, identičan
- ISO 8362-2:2024, identičan