CSN EN ISO 11608-4

CSN EN ISO 11608-4 This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system 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 that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. This document does not specify requirements for software in programmable NIS-E. NOTE - IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.