BAS EN ISO 8536-2:2024

Infuziona oprema za medicinsku primjenu – Dio 2: Zatvarači boca za infuziju


Opšte informacije
Status: Važeći
Broj strana: 19
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Datum objave: 10.06.2024
Tehnički komitet:
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Apstrakt
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. 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 8536-2:2023, identičan
  • ISO 8536-2:2023, identičan

Veza sa BAS standardima