This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software. The needle-based injection system containing electronics can be single use, reusable, and/or rechargeable. It is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories which are intended to be physically connected to a NIS or NIS-E during the NIS/NIS-E intended use. NOTE This document includes relevant requirements derived from IEC 60601 series.