Draft
International Standard
ISO/DIS 8536-6
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
Reference number
ISO/DIS 8536-6
Edition 4
© ISO 2024
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 8536-6:2016

ISO/DIS 8536-6

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Format
CHF 63
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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.

General information

  • Status
     : Under development
    Stage
    : Full report circulated: DIS approved for registration as FDIS [40.99]
  • Edition
     : 4
    Number of pages
     : 15
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.20 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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