UNE 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, Corrected version 2024-12)
Sistemas de inyección por agujas para uso médico. Requisitos y métodos de ensayo. Parte 4: Sistemas de inyección por agujas electrónicas (ISO 11608-4:2022, Versión corregida 2024-12) (Ratificada por la Asociación Española de Normalización en julio de 2022.)
| Standard number: | UNE EN ISO 11608-4:2022 |
| Pages: | 71 |
| Released: | 2022-07-01 |
| Status: | Standard |
UNE EN ISO 11608-4:2022
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.