被代替 YY 0598-2006
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:2006-08-29
实施日期:2007-08-01
分类信息
研制信息

归口单位: 中国药品生物制品检定所

起草单位: 百特(中国)投资有限公司、 中国药品生物制品检定所医疗器械检验中心

起草人: 冯晓明、 潘志成、 王健、 母瑞红、 柯林楠、 黄清泉、 奚廷斐

标准简介

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、浓缩物的处理、度量和标示,容器的要求和浓缩物质量检验所需的各项测试。本标准适用于血液透析或血液透析滤过用透析液的浓缩物。本标准不适用于治疗中浓缩物与透析用水配成最终使用浓度的混合过程。本标准不适用透析液的再生系统

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最后更新时间 2025-08-30