Applicable medical devices:
This standard applies to systems intended for use with needles and either replaceable or non-replaceable containers. The containers covered by the standard can be single or multi-dose syringe-based and cartridge-based systems – filled either by the manufacturer or by the user.
Testing capabilities to ISO 11608-5 include:
- Drug product preparation (e.g. Reconstitution)
- Needle preparation
- Air removal
- Priming
- Dose setting
- Actuation
- Needle insertion
- Injection of the medicinal product
- Disabling the nis-auto
- Needle retraction
- Needle shielding
- Needle hiding
- Sharps injury protection
- Needle removal
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 11608-5.
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