Standard name: Pen-injectors for medical use - Part 4: Requirements and test methods for elecronic and electromechanical pen-injectors (ISO 11608-4:2022).
Applicable medical devices:
This standard applies to electromechanically driven injectors intended for use with needles and either replaceable or non-replaceable cartridges. The injector may be for single use or multiple-use and excludes needle-free injectors (covered in ISO 21649), infusion pumps (as covered in IEC 60601-2-24), and injectors that are operating while connected to an external power supply.
Testing capabilities to ISO 11608-4 include:
- Visual and functional inspection
- Freedom from defects - after being subjected to cyclical preconditioning, to vibration, to shock, to free fall, to leakage, to dust according to IEC 60529, to damp heat according to IEC 60068-2-3
- Dose accuracy - when subjected to standard, cool and hot atmospheres
- Dose accuracy - after being subjected to dry heat storage preconditioning
- Dose accuracy - after being subjected to cold storage preconditioning
- Dose accuracy - of pen injectors with replaceable cartridges after delivery of claimed lifetime doses
- Lifetime test
- Preconditioning of pen injectors in dry heat atmosphere, cold storage atmosphere, cyclical atmosphere, by free fall, vibration, shock and for damp heat and the influence of fluid leakage.
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 are 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 11608-4:2022.
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