ISO 8536-6:2016

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

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Referenced standards

ISO 15378:2015ISO 15510:2014ISO 2230:2002ISO 3302-1:2014ISO 3302-2:2008ISO 48:2010ISO 7619-1:2010ISO 8536-1:2011ISO 8536-3:2009ISO 8871-1:2003ISO 8871-4:2006ISO 8871-5:2016
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ISO 8536-6:2016

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

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.

Edition2016
Standard Part No6
Published Date2016
Published ByInternational Standardization Organisation
Page Count16