ISO 11608-4:2022
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
Referenced standards
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Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
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, Clause?14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.
| Edition | 2022 |
|---|---|
| Standard Part No | 4 |
| Published Date | 2022 |
| Published By | International Standardization Organisation |
| Page Count | 63 |