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Standard

ISO 11040-4:2024

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Abstract

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 information

  • Standard from ISO
  • Published:
  • Edition: 4
  • Version: 1
  • Document type: IS
  • Pages
  • ICS 11.040.25
  • ISO TC ISO/TC 76

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