ISO/PRF 8536-6

Projet

Projet au stade approbation.

Remplacera ISO 8536-6:2016

Résumé

ISO 8536-6:2016 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.

Informations générales

État actuel
: Projet

Stade
: Texte final reçu ou FDIS enregistré pour approbation formelle [50.00]
Edition
: 4
Comité technique :
ISO/TC 76

ICS :
11.040.20
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