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.
EN ISO 11608-4:2007 history
2022EN ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
2007EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors