GB/T 44585.1-2024

Active

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

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

Standard Type

GBT

ICS

35.240.80

CCS

C30

Status

现行

Issue Date

2024-09-29

Implementation

2026-04-01

Responsible Dept

国家药监局

Drafting Unit

N/A

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