Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

This ISO 11608-5 standard specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans. Functions to be tested may be:

• 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
• needle removal