T/GDMDMA 0045—2025 广东省团体标准 血液净化装置的体外循环血路的临床使用指南 T/GDMDMA 0045—2025 * 华南理工大学出版社出版发行 广州市五山路华南理工大学17号楼（510641） 责任编辑：刘绮雯 何臻卓 广州小明数码印刷有限公司印刷 * 开本：880×1230 1/16 印张：1.25 字数：31千字 2025年6月第1版 2025年6月第1次印刷 * 书号：15410 ·707 定价：35.00元 版权所有  翻印必究 如有印刷质量问题，可寄本社退换ICS 11.040.20 CCS C 30 T/GDMDMA 0045—2025团 体 标 准 血液净化装置的体外循环血路的临床 使用指南 Clinical practice guideline for extracorpor eal blood cir cuit of blood purification device 2025-05-30 发布          2025 -05-30 实施 广东省医疗器械管理学会 发 布T/GDMDMA 全国团体标准信息平台 T/GDMDMA 0045—2025 Ⅰ目 次T/GDMDMA0045—2025 前言 ···························································································································· Ⅲ 1 范围 ························································································································· 1 2 规范性引用文件 ·········································································································· 1 3 术语和定义 ····················· ··························································································· 1 4 血液净化装置的体外循环血路产品特性 ············································································ 1 4.1 结构 ···················································································································· 1 4.2 工作原理 ·············································································· ································ 3 4.3 临床使用范围 ········································································································ 3 5 血液净化装置的体外循环血路操作规范（ 以血液透析技术为例 ） ············································· 3 5.1 通用要求 ·············································································································· 3 5.2 物品准备 ············································· ································································· 4 5.3 开机自检 ·············································································································· 4 5.4 血液透析器和管路的安装 ························································································· 4 5.5 密闭式预冲 ·································································································· ········· 4 5.6 建立体外循环（ 上机） ······························································································ 4 5.7 回血下机 ·············································································································· 6 6 血液净化装置的体外循环血路不良事件及处理 ··································································· 8 6.1 体外循环血路治疗中常见不良事件及处理 ·············································· ······················ 8 6.2 不良事件报告相关要求 ·························································································· 10 参考文献 ······················································································································ 12 全国团体标准信息平台 T/GDMDMA 0045—2025 Ⅱ全国团体标准信息平台 T/GDMDMA 0045—2025 Ⅲ前言 本文件按照GB/T 1.1—2020《标准化工作导则 第1部分：标准化文件的结构和起草规则》的规定 起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由广东省药品不良反应监测中心提出。 本文件由广东省医疗器械管理学会归口。 本文件起草单位：南方医科大学第三附属医院、贝恩医疗设备（广州）有限公司、广东省药品不 良反应监测中心、健帆生物科技集团股份有限公司、中山大学附属第八医院、广东百合医疗科技股份 有限公司、广州医科大学附属第二医院、广州医科大学附属第一医院、中山大学附属第五医院、广州 市第一人民医院、中山大学孙逸仙纪念医院、暨南大学附属第一医院、中山大学附属第三医院、广州 中医药大学第一附属医院、乾德生物医疗技术有限（重庆）公司、高州市人民医院、广州中医药大学 第一附属医院白云医院。 本文件主要起草人：傅渊锋，张群，汤颖，付莎，杨铁城，梁剑波，肖洁，王成，梁鸣，徐安平， 刘璠娜，叶增纯，陈刚毅，刘爱群，李荣华，廖磊，江晓兵，邹果然，黄凯，郭德久，唐金龙，罗敏 红，肖育华，张云仙，刘舜莉，张正尧。 全国团体标准信息平台 4T/GDMDMA 0045—2025 Ⅳ全国团体标准信息平台 1T/GDMDMA 0045—2025 血液净化装置的体外循环血路的临床使用指南 1  范围 本文件明确了血液净化装置的体外循环管路的工作原理、临床使用范围，规范了临床操作、不良 事件的处理等内容。 2  规范性引用文件 下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文 件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适 用于本文件。 GB/T 13074 血液净化术语 3  术语和定义 GB/T 13074界定的以及下列术语和定义适用于本文件。 3.1  医疗器械不良事件 medical device adverse event 是指已上市的医疗器械，在正常使用情况下发生的，导致或者可能导致人体伤害的各种有害事件。 3.2  严重伤害 serious injury 是指有下列情况之一者： a） 危及生命； b） 导致机体功能的永久性伤害或者机体结构的永久性损伤； c） 必须采取医疗措施才能避免上述永久性伤害或者损伤。 4  血液净化装置的体外循环血路产品特性 4.1  结构 由血液侧管路（动脉管路、静脉管路）和其他辅助管路组成。无菌提供，一次性使用。一般红色 为动脉管路，蓝色为静脉管路。动脉管路主要由主管、支管、泵管、肝素管、透析器接头、透析器接 头帽