EN 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)
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.
EN ISO 11608-4:2022 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