ISO 11608-4:2022 医用针头注射系统 要求和试验方法 第4部分：含电子元件的针式注射

标准编号：ISO 11608-4:2022

中文名称：医用针头注射系统 要求和试验方法 第4部分：含电子元件的针式注射

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

发布日期：2022-04

标准范围

本文件规定了针基注射系统（NISs）的要求和测试方法，该系统包含有或没有软件（NIS Es）的电子设备。包含电子元件的针头注射系统可以一次性使用或重复使用，并且可以在与其他设备进行电气/导电连接的情况下或不进行电气/导电连接的情况下进行操作。该系统旨在通过自我给药或由其他操作员（如医务人员或医疗保健提供者）给患者给药。本文件适用于根据NIS/NIS-E预期用途物理连接至NIS或NIS-E的电子附件。本文件还适用于根据NIS/NIS-E预期用途与NIS或NIS-E进行电气/导电连接的电子附件。本文件未规定可编程NIS中的软件要求-E注？IEC 60601-1:2005+AMD1:2012+AMD2:2020，第14条涉及软件生命周期过程。本文件未规定网络安全要求。

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.

标准预览图