Draft
International Standard
ISO/DIS 11040-8
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Reference number
ISO/DIS 11040-8
Edition 2
© ISO 2025
Draft International Standard
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 11040-8:2016

Abstract

ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.

Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.

General information

  • Status
     : Under development
    Stage
    : DIS registered [40.00]
  • Edition
     : 2
    Number of pages
     : 24
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.25 
  • 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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