被代替 YY/T 0598-2015
血液透析及相关治疗用浓缩物 血液透析及相关治疗用浓缩物 Concentrates for haemodialysis and related therapies
发布日期:2015-03-02
实施日期:2017-01-01
分类信息
研制信息

归口单位: 全国医用体外循环设备标准化技术委员会(SAC/TC 158)

起草单位: 国家食品药品监督管理局广州医疗器械质量监督检验中心

起草人: 黄敏菊、 何燕英、 王培连

标准简介

本标准适用于血液透析及相关治疗用浓缩物。本标准规定了浓缩物的化学成分组成及其纯度,微生物污染的监测,浓缩物的处理、度量和标识,容器的要求和浓缩物质量检验所需要的各项测试等要求。本标准不适用于治疗中浓缩物与透析用水配制成最终使用浓度的混合过程和透析液的再生系统

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最后更新时间 2025-09-02