Infusion equipment for medical use -- Part 6: Freeze drying closures for infusion bottles
Это стандарт пересмотрен ISO 8536-6:2016
ISO 8536-6:2009 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are 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 ISO 8536-6:2009 are intended for single use only.