Standard name: Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016).
Applicable medical devices:
This standard section applies to aseptically filled or terminally sterilised finished prefilled syringes, which are intended for single use applications. Prefilled syringes which need to undergo an additional preparation step by the user (i.e. reconstitution) before their use aren’t included as part of this standard’s scope.
Testing 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).
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 11040-8:2016.
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