Standard No.:	GB/T 44585.1-2024
English Name:	Application of risk management for medical device connecting IT-network—Part 1：Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Chinese Name:	风险管理在接入IT网络的医疗器械中的应用 第1部分：联网医疗器械或健康软件在其实施和使用中的安全、有效性和网络安全
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	35.240.80 35.240.80    IT applications in health care technology 35.240.80
Source Content Issued by:	SAMR, SAC
Issued on:	2024-09-29
Implemented on:	2026-4-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	21500 words
Translation Price(USD):	645.0
Delivery:	via email in 1~5 business day

本文件规定了在健康IT基础设施内连接健康IT系统之前、期间和之后，组织机构通过同时让适当的利益相关方参与进来的方式处理安全、有效性和网络安全这三个关键属性应用风险管理方面的一般要求。
本文件适用于联网医疗器械或健康软件在生存周期实施和使用阶段的风险管理。