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RS ISO 11608-4: 2022
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics

Abstract

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.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11608-4: 2022	ADOPTED ISO STANDARDS	Health care technology	71	Second Edition Jul 2026	Available