T/GDMDMA 0044—2025 广东省团体标准 一次性使用血液灌流器的临床使用指南 T/GDMDMA 0044—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：2.5 字数：69千字 2025年6月第1版 2025年6月第1次印刷 * 书号：15410 ·706 定价：45.00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 0044—2025团 体 标 准 一次性使用血液灌流器的临床使用指南 Clinical practice guideline for disposable hemoperfutor 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 0044—2025 Ⅰ目 次T/GDMDMA0044—2025 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 一次性使用血液灌流器的产品特性 ·················································································· 2 4.1 结构及组成 ······································································ ····································· 2 4.2 质量标准 ·············································································································· 2 4.3 分类 ···················································································································· 3 5 血液灌流的原理 ·········································································································· 3 6 血液灌流规范化操作程序 ······························································································ 3 6.1 单纯血液灌流治疗 ·································································································· 3 6.2 组合式血液灌流联合血液透析治疗 ············································································· 6 7 血液灌流的治疗监测 ······································································ ······························ 7 7.1 出凝血功能监测 ····································································································· 7 7.2 体外循环系统监测 ·································································································· 7 7.3 生命体征的监测 ····································································································· 7 7.4 治疗毒物中毒时反跳现象监测 ··········· ········································································ 7 8 血液灌流的不良事件及处理 ··························································································· 7 8.1 常见不良事件及处理措施 ························································································· 7 8.2 不良事件报告相关要求 ·························································································· 15 附录 A（资料性） 灌流器常见型号 ····················································································· 17 附录 B（资料性） 常用吸附剂 ··························································································· 23 附录 C（资料性） 血液灌流的临床适应证和禁忌证 ································································ 24 参考文献 ····································································································· ················· 28 全国团体标准信息平台 T/GDMDMA 0044—2025 Ⅱ全国团体标准信息平台 T/GDMDMA 0044—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、健帆生物科技集团股份有限公司、广东省药品不 良反应监测中心、广州康盛生物科技股份有限公司、中山大学附属第八医院、佛山市博新生物科技有 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、重庆希尔康血液净化器材研发有限公 司、淄博康贝医疗器械有限公司、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，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，李荣华，朱梦晓，刘虎，杨雪飞，梁达星，郭德久，唐金龙，张文，王为超， 罗敏红，肖育华，张云仙，王梦杰，谢钰绚，林晓娟。 全国团体标准信息平台 4T/GDMDMA 0044—2025 Ⅳ  引言 血液灌流（ Hemope