现行 YY/T 1708.4-2021
医用诊断X射线影像设备连通性符合性基本要求 第4部分:数字减影血管造影X射线机 医用诊断X射线影像设备连通性符合性基本要求 第4部分:数字减影血管造影X射线机 Basic requirements of communication and conformance for medical X-ray image equipment—Part 4:Digital subtraction angiography equipment
发布日期:2021-09-06
实施日期:2022-09-01
分类信息
研制信息

归口单位: 全国医用电器标准化技术委员会医用X射线设备及用具分技术委员会(SAC/TC 10/SC 1)

起草单位: 佳能医疗系统(中国)有限公司、 国家药品监督管理局医疗器械技术审评中心、 乐普(北京)医疗装备有限公司、 西门子(深圳)磁共振有限公司、 辽宁省医疗器械检验检测院

起草人: 李巍、 张宇晶、 周秀成、 康杰、 肖亚辉、 赵佳洋

标准简介

本标准在第1部分的基础上规定了数字减影血管造影X射线机(简称DSA)及其相关的软件组件的连通性符合性的术语定义、要求和试验方法。本标准适用于具有可通过数字介质存储或通过网络传输健康数据且具有数字减影功能的医用血管造影X射线机设备及其相关组件。本标准不适用于不具备数字介质存储和网络传输健康数据功能或不具备数字减影功能的医用血管造影X射线机设备及其相关组件

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最后更新时间 2025-09-02