TZMDS 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

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TZMDS 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

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ICS35.240.80CCSC30

ZMDS

中关村医疗器械产业技术创新联盟团体标准

T/ZMDS20007-2023

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

HealthsoftwareandhealthITsystemssafety,effectivenessandsecurity

—Part1:Principlesandconcepts

（ISO81001-1:2021,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

T/ZMDS20007-2023/ISO81001-1:2021

前言································

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引言································

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III

范围································

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1.1目的································

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1.2应用领域································

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············

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

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

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

关键属性和过程 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································ ································ ································ ················ 11

4.2社会技术生态系统································ ································ ······························ 12

4.3体系··················

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TZMDS 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