Status : Published
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Abstract

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

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.

General information

  • Status
     : Published
    Publication date
     : 2023-01
    Stage
    : International Standard published [60.60]
  • Edition
     : 4
    Number of pages
     : 12
  • 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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