ICS 35.240.80
ZMDS
中关村医疗器械产业技术创新联盟团体标准
T/ZMDS 20003-2019
医疗器械网络安全风险控制 医疗器械网络
安全能力信息
Medical device security risk control
– information of medical device security capabilities
2019 -11-18发布 2019 -11-18实施
中关村医疗器械产业技术创新联盟 发布
全国团体标准信息平台
目 次
1 范围 ................................ ................................ ................................ ................................ ............................. 6
2 术语与定义 ................................ ................................ ................................ ................................ ................. 6
2.1 自动注销 AUTOMATIC LOGOFF (ALO F) ................................ ................................ ......................... 6
2.2 审核控制 AUDIT CONTROLS (AUDT) ................................ ................................ .............................. 6
2.3 授权 AUTHORIZATION (AUTH) ................................ ................................ ................................ ....... 6
2.4 安全特性配置 (CONFIGURATION OF SECURITY FEATURES - CNFS) ................................ ........... 7
2.5 网络安全产品升级( CYBER SECURITY PRODUCT UPGRADES – CSUP) ................................ ...... 7
2.6 健康数据身份信息去除( HEALTH DATA DE -IDENTIFICATION – DIDT) ................................ ...... 7
2.7 数据备份与灾难恢复( DATA BACKUP AND DISASTER RECOVERY – DTBK) ............................... 7
2.8 紧急访问( EMERGENCY ACCESS – EMRG) ................................ ................................ ................. 7
2.9 健康数据完整性与真实性 (HEALTH DATA INTEGRITY AND AUTHENTICITY – IGAU) ..................... 7
2.10 恶意软件探测与防护( MALWARE DETECTION/PROTECTION – MLDP) ................................ .... 7
2.11 网络节点鉴别( NODE AUTHENTICATION – NAUT) ................................ ................................ .... 7
2.12 人员鉴别( PERSON AUTHENTICATION – PAUT) ................................ ................................ ......... 7
2.13 物理锁( PHYSICAL LOCKS ON DEVICE – PLOK) ................................ ................................ ........... 8
2.14 第三方组件维护计划( THIRD -PARTY COMPONENTS IN PRODUCT LIFECYCLE ROADMAPS –
RDMP) ................................ ................................ ................................ ................................ .......................... 8
2.15 系统与应用软件硬化( SYSTEM AND APPLICATION HARDENING – SAHD) ............................... 8
2.16 安全指导( SECURITY GUIDES – SGUD) ................................ ................................ ...................... 8
2.17 健康数据存储保密性( HEALTH DATA STORAGE CONFIDENTIALITY – STCF) ............................. 8
2.18 传输保密性( TRANSMISSION CONFIDENTIALITY – TXCF) ................................ .......................... 8
2.19 传输完整性( TRANSMISSION INTEGRITY – TXIG) ................................ ................................ ...... 8
2.20 责任方 RESPONSIBLE ORGANIZATION ................................ ................................ .......................... 8
2.21 关键特性 KEY PROPERTIES ................................ ................................ ................................ ............. 9
3 医疗器械制造商信息披露要求 ................................ ................................ ................................ ................. 9
3.1 总则 ................................ ................................ ................................ ................................ ................ 9
3.2 产品描述信息 ................................ ................................ ................................ ................................ 9
全国团体标准信息平台
3.3 隐私数据管理 ................................ ................................ ................................ ................................ 9
3.4 网络安全能力披露 ................................ ................................ ................................ ...................... 10
3.4.1 自动注销能力 ALOF ................................ ................................ ..........
T-ZMDS 20003—2019 医疗器械网络安全风险控制 – 医疗器械网络安全能力信息
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