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ISO 8536-6

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

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Organization: ISO
Publication Date: 1 December 2016
Status: active
Page Count: 24
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This document 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.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Document History

ISO 8536-6
December 1, 2016
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
This document 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...
November 15, 2009
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
This part of ISO 8536 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...
April 1, 1995
Infusion Equipment for Medical Use - Part 6: Freeze Drying Closures for Infusion Bottles First Edition
A description is not available for this item.

References

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