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

The ISO 11040-4 standard specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods for tubing-glass barrels for injection preparations, and sterilized subassembled syringes ready for filling.

The test methods include:

• Test methods for syringe barrels
• Glide force test method to evaluate syringe lubrication
• Needle penetration test
• Test methods for closure systems
• Dye solution tightness test