ICS11.020.20 CCSC00 团体标准 T/BRACDCHE006-2026 医疗机构医疗器械研究型病房建设规范 Specificationsfortheconstructionofmedicaldeviceresearchwardsinmedical institutions 2026-3-27发布 2026-3-27实施 北京慢性病防治与健康教育研究会 发布 全国团体标准信息平台 T/BRACDCHE006－2026 I目次 前 言...........................................................................................................................................................II 引 言.........................................................................................................................................................III 1范围.....................................................................................................................................................................1 2规范性引用文件.................................................................................................................................................1 3术语和定义.........................................................................................................................................................1 4缩略语.................................................................................................................................................................1 5基本要求.............................................................................................................................................................2 5.1医疗机构资质与要求.................................................................................................................................2 5.2研究型病房资质与要求.............................................................................................................................2 6研究型病房建设.................................................................................................................................................3 6.1筛选区建设.................................................................................................................................................3 6.2医疗区建设.................................................................................................................................................3 6.3操作区建设.................................................................................................................................................4 6.4工作区建设.................................................................................................................................................4 7研究团队组建.....................................................................................................................................................4 7.1研究型病房主任.........................................................................................................................................4 7.2主要研究者.................................................................................................................................................5 7.3研究者.........................................................................................................................................................5 7.4研究护士.....................................................................................................................................................5 7.5器械管理员.................................................................................................................................................5 7.6生物统计师.................................................................................................................................................6 7.7质控员.........................................................................................................................................................6 7.8资料管理员.................................................................................................................................................6 7.9样本管理员.................................................................................................................................................6 8制度建设...............