标准号：ISO 23500-2011
实施状态：作废
中文名称：血液透析及相关治疗用液体的制备和质量管理指南
英文名称：Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
发布日期：2011-05-15
被替代标准：ISO 23500-2014
代替标准：ISO/FDIS 23500-2011
采用标准：BS ISO 23500-2011,IDT
起草单位：ISO/TC 150
标准简介：1.1 General
This International Standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for
haemodialysis and related therapies and substitution fluid for use in online therapies, such as
haemodiafiltration and haemofiltration. As such, this International Standard functions as a recommended
practice.
1.2 Inclusions
This International Standard addresses the user's responsibility for the dialysis fluid once the equipment used
in its preparation has been delivered and installed. For the purposes of this International Standard, the dialysis
fluid includes water used for the preparation of dialysis fluid and substitution fluid, water used for the
preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and
substitution fluid.
Included in the scope of this International Standard are
a) the quality management of equipment used to treat and distribute water used for the preparation of
dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the
point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis
facility, and
c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE Because water used to prepare dialysis fluid is commonly prepared and distributed using the same equipment
as the water used to reprocess dialysers, water used to reprocess dialysers is also covered by this International Standard.
1.3 Exclusions
Excluded from the scope of this International Standard are sorbent-based dialysis fluid regeneration systems
that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement
therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis.
文件格式：PDF
文件大小：704.98KB
文件页数：90
（以上信息更新时间为：2019-11-22）
ISO 23500-2011 血液透析及相关治疗用液体的制备和质量管理指南.pdf
(704.98 KB)
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