NBN ISO 8536-6:2021

NBN ISO 8536-6:2021

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles ISO 8536-6:2016

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Détails

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. 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.
Directives : Not yet available in DB

Informations supplémentaires

Auteur Bureau de Normalisation Belge (NBN)
Edité par NBN
Type de document Norme
ICS 11.040.20 : Matériel de transfusion, de perfusion et d'injection
Historique No
Mot-clé ISO 8536-6, ISO 8536-6:2021