International Standard
ISO 8536-6:2025
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
Reference number
ISO 8536-6:2025
Edition 4
2025-03
© ISO 2025
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Published (Edition 4, 2025)

ISO 8536-6:2025

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Format
CHF 98
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Abstract

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 be strongly affected by the nature and performance of the primary packaging.

General information

  • Status
     : Published
    Publication date
     : 2025-03
    Stage
    : International Standard published [60.60]
  • Edition
     : 4
    Number of pages
     : 16
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.20 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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