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About This Item

 

Full Description

ISO 11040-4:2015 applies to

  • tubing-glass barrels (single-chamber design) for injection preparations, and
  • sterilized subassembled syringes ready for filling.

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

ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040-4:2015.

 

Document History

  1. ISO 11040-4:2015

    👀currently
    viewing


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

    • Most Recent
  2. ISO 11040-4:2007


    Prefilled syringes - Part 4: Glass barrels for injectables

    • Historical Version
  3. ISO 11040-4:1996


    Prefilled syringes -- Part 4: Glass barrels for injectables

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11040-4:2015/Amd1:2020


    - Amendment 1