ISO 11040-4:2015

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

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.

Edition	2015
Standard Part No	4
Published Date	2015
Published By	International Standardization Organisation
Page Count	52