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About This Item

 

Full Description

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.
 

Document History

  1. ISO 8536-2:2023

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    Infusion equipment for medical use - Part 2: Closures for infusion bottles

    • Most Recent
  2. ISO 8536-2:2010


    Infusion equipment for medical use - Part 2: Closures for infusion bottles

    • Historical Version
  3. ISO 8536-2/Cor1:2003


    Infusion equipment for medical use - Part 2: Closures for infusion bottles - Corrigendum

    • Historical Version
  4. ISO 8536-2:2001


    Infusion equipment for medical use -- Part 2: Closures for infusion bottles

    • Historical Version