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Testing of prefilled syringes with plastic barrels - ISO 11040-6

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