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DIN ISO 8536-6

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)

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Organization: DIN
Publication Date: 1 September 2017
Status: active
Page Count: 23
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

DIN ISO 8536-6
September 1, 2017
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)
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...
April 1, 2017
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016); Text in German und English
A description is not available for this item.
September 1, 2012
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2009)
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...
July 1, 1996
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:1995)
A description is not available for this item.

References

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