BAS EN ISO 8362-2:2025

Injekcioni spremnici i dodatna oprema – Dio 2: Zatvarači za injekcione vijale


Opšte informacije
Status: Važeći
Broj strana: 10
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum 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