ISO 11040-4:2015

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

OVERVIEW

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.

COMMENTS

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PRODUCT DETAILS

Status Withdrawn - 03 Jun 2024
Edition 2015
No. of Pages 52
ICS Classification 11.040.25 Syringes, needles and catheters
Committee ISO/TC 76
Available for Purchase For sale in Singapore only
Adoption ISO