BSI 20/30387730 DC 2020
$13.70
BS EN ISO 11608-4. Needle-based injection systems for medical use. Requirements and test methods – Part 4. Needle-based injection systems containing electronics
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 58 |
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.
This document includes relevant requirements derived from IEC 60601 series.
