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ISO 11608-4:2022

Current Revision

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics

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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, Clause 14 addresses software life cycle processes.

This document does not specify requirements for cybersecurity.


SDO ISO: International Organization for Standardization
Document Number ISO 11608
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 84
Publish Date Document Id Type View
Not Available ISO 11608-4:2022 Revision