Final Draft
International Standard
ISO/FDIS 8871-5
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
Reference number
ISO/FDIS 8871-5
Edition 3
© ISO 2024
Final Draft International Standard
Under development
This draft is in the approval phase.
Will replace ISO 8871-5:2016

Abstract

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

General information

  • Status
     : Under development
    Stage
    : Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
  • Edition
     : 3
    Number of pages
     : 11
  • 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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