Could I help you?
Reduced price! ISO 11608-4:2022 View larger

ISO 11608-4:2022

M00028067

New product

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

standard by International Organization for Standardization, 04/01/2022

More details

In stock

$118.80 tax incl.

-56%

$270.00 tax incl.

More info

Full Description

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.