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
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07-04-2022
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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.
| Committee |
ISO/TC 84
|
| DocumentType |
Standard
|
| Pages |
63
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11608-4:2022 | Identical |
| UNI EN ISO 11608-4:2022 | Identical |
| ÖNORM EN ISO 11608-4:2022 | Identical |
| I.S. EN ISO 11608-4:2022 | Identical |
| PN-EN ISO 11608-4:2022-11 | Identical |
| NS-EN ISO 11608-4:2022 | Identical |
| UNE-EN ISO 11608-4:2022 | Identical |
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