UNE-EN ISO 11608-4:2022
Current
The latest, up-to-date edition.
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)
Hardcopy , PDF
English
01-07-2022
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.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
71
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11608-4:2022 | Identical |
| ISO 11608-4:2022 | Identical |
| DIN EN ISO 11608-4:2022-09 | Equivalent |
| BS EN ISO 11608-4:2022 | Equivalent |
| I.S. EN ISO 11608-4:2022 | Equivalent |
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