Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion pumps (as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.