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About This Item

 

Full Description

This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This document also specifies components that are part of the sterilized subassembled syringe ready for filling.

This document is applicable to
— tubing-glass barrels (single-chamber design) for injection preparations, and
— sterilized subassembled syringes ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.

NOTE: National or regional regulations such as Ph.Eur., USP, or JP can apply.
 

Document History

  1. ISO 11040-4:2024

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    Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

    • Most Recent
  2. ISO 11040-4:2015


    Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

    • Historical Version
  3. ISO 11040-4:2007


    Prefilled syringes - Part 4: Glass barrels for injectables

    • Historical Version
  4. ISO 11040-4:1996


    Prefilled syringes -- Part 4: Glass barrels for injectables

    • Historical Version