GB 12264-1990
Replaced
GB/T 43050-2023
Active
National standards
GB/T 43050-2023 Preparation and quality management of fluids for haemodialysis and related therapies—General requirements
GB/T 43050-2023 Preparation and quality management of fluids for haemodialysis and related therapies—General requirements
Basic Information
Standard Code:
GB/T 43050-2023
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2023-09-07
Implement Date:
2025-04-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用体外循环设备标准化技术委员会(SAC/TC 158)
Pages:
76 pages
Scope
本文件规定了当透析用液体的制造设备完成安装及交付后，透析用液体使用者的责任。
本文件中所指的透析用液体包括：
a) 用于制备透析液和置换液的透析用水（见3.17）；
b) 在使用者设施中配制浓缩物时使用的透析用水；
c) 浓缩物；
d) 最终的透析液和置换液。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、山东威高血液净化制品股份有限公司、贝恩医疗设备(广州)有限公司、广州康盛生物科技股份有限公司、北京迈淩医疗技术发展有限公司、费森尤斯医药研发(上海)有限公司
Drafting Persons:
何晓帆、胡相华、徐苏华、吴少海、谢妍、黄敏菊、傅音波、蒋顺忠、杨正根、佟凯、黄阳、史振伟、尹良红、卢翰生、温少君、涂荣
Referenced Standards
YY/T 0793.1-2022 Preparation and quality management of fluids for haemodialysis and related therapies—Part 1:Water treatment equipment for haemodialysis applications and related therapies
YY/T 0793.4-2022 Preparation and quality management of fluids for haemodialysis and related therapies—Part 4:Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-3:2019
ISO 23500-4:2019
Adopt standards
ISO 23500-1:2019
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced