Standard name: Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
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
- Dose setting
- Needle insertion
- Injection of the medicinal product
- Disabling the nis-auto
- Needle retraction
- Needle shielding
- Needle hiding
- Sharps injury protection
- Needle removal
Other ISO 11608 Sections include:
- ISO 11608-2: 2022 Needles
- ISO 11608-3: 2022 Finished containers
- ISO 11608-4: 2022 Electronic and electromechanical pen-injectors
- ISO 11608-5: 2022 Automated functions
Part 2, 3 and 5 of ISO 11608 series specifies common test methods to support performance requirements for sterile double-ended needles and containers intended for use in conjunction with needle-based injection systems and the automated function of NISs.
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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