Abstract
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.
Next version under development
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Draft
International StandardISO/DIS 8536-6
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
Reference number
ISO/DIS 8536-6
ISO/DIS 8536-6
Edition 1
© ISO 2024
Draft International Standard
ISO/DIS 8536-6
Infusion equipment for medical use
Part 6: Freeze drying closures for infusion bottles
Life cycle
-
Previously
WithdrawnISO 8536-6:2009
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Now
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Will be replaced by
Under developmentISO/DIS 8536-6
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