BS EN ISO 11608-4:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics
Hardcopy , PDF
English
28-08-2025
| Committee |
CH/84
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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, Clause14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.
| Standards | Relationship |
| DIN EN ISO 11608-4:2022-09 | Equivalent |
| I.S. EN ISO 11608-4:2022 | Equivalent |
| EN ISO 11608-4:2022 | Identical |
| ISO 11608-4:2022 | Identical |
| EN ISO 11608-4:2022 | Equivalent |
| ISO 11608-4:2022 | Equivalent |
| UNE-EN ISO 11608-4:2022 | Equivalent |
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