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