ICS07.080 CCSC05 团体标准 T/SATA095—2026 人成体干细胞来源肝脏类器官构建及技术 要求 ConstructionalandTechnicalRequirementsforHumanAdultStemCell-Derived LiverOrganoids 2026-03-27发布 2026-04-27实施 深圳市分析测试协会  发布 全国团体标准信息平台 全国团体标准信息平台 T/SATA095—2026 I目次 前言.................................................................................III 引言..................................................................................IV 1范围................................................................................1 2规范性引用文件......................................................................1 3术语和定义..........................................................................1 4缩略语..............................................................................2 5技术路线............................................................................3 6通用要求............................................................................3 6.1伦理要求........................................................................3 6.2生物安全要求....................................................................3 6.3数据要求........................................................................4 6.4质量要求........................................................................4 附录A（规范性）人成体干细胞来源正常肝脏和肝癌类器官的构建.............................5 A.1概述............................................................................5 A.2仪器设备及试剂耗材..............................................................5 A.2.1仪器设备....................................................................5 A.2.2耗材........................................................................5 A.2.3试剂及培养基................................................................5 A.3人正常肝脏和肝癌类器官制备......................................................6 A.3.1组织样本的保存与运输........................................................6 A.3.2组织样本的预处理............................................................6 A.3.3组织块的清洗................................................................6 A.3.4组织块的消化及组织细胞混悬液过滤............................................6 A.3.5细胞分选（可选）............................................................6 A.3.6细胞重悬及接种..............................................................7 A.3.7类器官培养..................................................................7 A.3.8类器官传代..................................................................7 A.3.9正常肝脏类器官分化..........................................................7 A.4人正常肝脏和肝癌类器官冻存和复苏................................................8 A.4.1类器官冻存..................................................................8 A.4.2类器官复苏..................................................................8 附录B（规范性）人成体干细胞来源正常肝脏和肝癌类器官构建的技术要求.....................9 B.1概述............................................................................9 B.2细胞活性........................................................................9 B.2.1要求........................................................................9 B.2.2检测方法....................................................................9 B.3类器官光学形态学特征............................................................9 全国团体标准信息平台 T/SATA095—2026 IIB.3.1要求........................................................................9 B.3.2检测方法....................................................................9 B.4类器官组织学特征................................................................9 B.4.1要求........................................................................9 B.4.2检测方法...................................................................10 B.5类器官功能学...................................................................10 B.5.1要求.......................................................................11 B.5.2检测方法...................................................................11 B.6类器官分子分型.................................................................11 B.6.1要求.......................................................................11 B.6.2检测方法...................................................................11 B