Standard No.:	YY/T 0793.4-2022
English Name:	Preparation and quality management of fluids for hacmodialysis andrelated therapics—Part 1:Water treatment equipment for haemodialysis applications and related therapies
Chinese Name:	血液透析和相关治疗用液体的制备和质量管理 第4部分：血液透析和相关治疗用透析液质量
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2022-07-01
Implemented on:	2023-7-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	15500 words
Translation Price(USD):	240.0
Delivery:	via email in 1~5 business day

本文件规定了用于血液透析和相关治疗用透析液的最低质量要求。
本文件不适用于透析液制备用水；
血液透析及相关治疗用浓缩物；
制备透析液所用的设备；
基于吸附的透析液再生系统，该系统可再生和再循环少量透析液；
采用预包装溶液的连续性血液净化治疗系统；
腹膜透析液；
腹膜透析设备；
在线血液滤过或在线血液透析滤过的置换液；
非在线配制的血液透析滤过和血液滤过的置换液。