Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

The ISO 11040-6 standard specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.

Testing includes:

• 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