YY 0793.3-2023Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Concentrates for haemodialysis and related therapies (English PDF)

YY 0793.3-2023 is the English-translated version of 血液透析和相关治疗用液体的制备和质量管理 第3部分：血液透析和相关治疗用浓缩物.

YY 0793.3 sets the requirements for the concentrates from which dialysis fluid is made, the liquid and dry acid and bicarbonate products a dialysis machine dilutes with treated water. It specifies what such a concentrate has to contain and to what tolerance, the purity of the chemicals used, the microbiological limits, the labelling that prevents the wrong concentrate being connected, and the quality management the manufacturer has to operate. An error in concentration reaches the patient directly and continuously: the electrolyte composition of the fluid across the membrane determines the electrolyte composition of the patient's blood. Being a YY standard without the /T suffix, compliance is compulsory in China. It takes effect in July 2025 and completes the series alongside Part 2 on dialysis water.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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