DIN EN ISO 11608-4:2016-03

This part of ISO 11608 specifies reference requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software) intended to be used with needles and with replaceable or non-replaceable containers. The electronic needle based injection system (ENIS) can be single use, reusable, and/or rechargeable. It is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for a) needle-free injectors (as covered in ISO 21649); nor b) infusion pumps (as covered in IEC 60601-2-24); nor c) devices that are capable of operating while connected to an external power supply.