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.
Status: PublishedPublication date: 2016-12
Edition: 3Number of pages: 16
Technical Committee: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
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A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)
Corrigenda / AmendmentsUnder development