Standard name: Prefilled syringes - Part 8: Requirements and test methods for aseptically processed or terminally sterilized finished prefilled syringes (ISO 11040-8:2026).
ISO 11040-8:2016 was revised and replaced by ISO 11040-8:2026 in June 2026, introducing updated functional performance requirements, additional test methods, and a more comprehensive framework for the design verification of finished prefilled syringes.Applicable medical devices:
This standard section applies to aseptically processed or terminally sterilized finished prefilled syringes, which are intended for single use applications. ISO 11040-8:2026 does not apply to finished prefilled syringes that undergo an additional preparation step by the user before injection, such as diluent-containing syringes used for reconstitutionTesting capabilities to ISO 11040-8 include:
- Fill volume (including tolerances)
- Break loose and extrusion forces
- Resistance – burst and break of the closure system, finger flange and luer cone
- Luer lock adaptor collar pull-off force – closure systems forces
- Luer lock adaptor collar torque resistance
- Luer lock rigid tip cap unscrewing torque
- Pull-off force – tip cap and needle shield
- Connectivity with fluid connectors
- Leakage at FPFS and connectors
- Residual volume
- Needle penetration force
- Needle pull-out/off force
- Liquid leakage beyond plunger
- Deliverable volume ( Dose accuracy ISO 11608-1).
Custom Testing
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of EN ISO 11040-8:2026.
