T_ZMDS 20007-2023 健康软件和健康IT系统安全性、有效性和网络安全— 第1部分：原则和概念.docx

学兔兔ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ标准下载ICS?35.240.80

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CCS?C30

ZMDS

中关村医疗器械产业技术创新联盟团体标准

T/ZMDS?20007-2023

健康软件和健康?IT?系统安全性、有效性和

网络安全—第?1?部分：原则和概念

Health?software?and?health?IT?systems?safety,?effectiveness?and?security

—Part1:?Principles?and?concepts

（ISO?81001-1:2021,?IDT）

2023-12-29?发布 2023-12-29?实施

中关村医疗器械产业技术创新联盟 发?布

学兔兔ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ标准下载T/ZMDS?20007-2023/ISO?81001-1:2021

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目 录

前言?·····························································································································II

引言?····························································································································III

1?范围?···························································································································1

1.1?目的?··················································································································1

1.2?应用领域?············································································································1

2?规范性引用文件?············································································································1

3?术语和定义?··················································································································1

3.1?组织、人员和角色?································································································1

3.2?关键属性和过程?···································································································3

3.3?健康信息和技术?···································································································5

3.4?风险管理?············································································································8

4?核心主题?···················································································································11

4.1?概述?·······················