Requirements and test methods for prefilled syringes - ISO 11040-8

Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes


The ISO 11040-8 standard is applicable to aseptically filled or terminally sterilized finished prefilled syringes based on ISO 11040-4 or ISO 11040-6 with focus on quality, functional performance and safety requirements, as well as relevant test methods.

The test methods include:

  • Break loose and extrusion forces
  • Burst resistance
  • Break resistance
  • Closure system forces and torques
  • Connectivity with fluid path connectors
  • Residual volume
  • Needle penetration force
  • Needle pull-out force
  • Sharps injury protection requirements
  • Liquid leakage beyond plunger