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ISO 11040-4:2015

Historical Revision

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

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11040
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 76
Publish Date Document Id Type View
Not Available ISO 11040-4:2024 Revision
Not Available ISO 11040-4:2015 Revision