Nom | Support | Langue | Disponibilité | Date d'édition | Prix | ||
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PDF |
Anglais |
Active |
31/05/2021 |
89,00 € |
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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) |
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Edité par | NBN |
Type de document | Norme |
ICS | 11.040.20 : Matériel de transfusion, de perfusion et d'injection
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Historique | No |
Mot-clé | ISO 8536-6, ISO 8536-6:2021 |