YY 0793.3-2023Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Concentrates for haemodialysis and related therapies (English PDF)
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
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
June 20, 2023
Implementation date
July 1, 2025
Scope
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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Document preview — YY 0793.3-2023
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This document was issued on 20 June 2023 by the National Medical Products Administration and takes effect on 1 July 2025.
It is a YY standard without the /T suffix: compliance is mandatory in China.
1 Scope
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.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
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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Related Standards
YY 0793.1-2010 — Technical requirements of water treatment equipment for haemodialysis applications and related therapies - Part 1: For multi-bed haemodialysis
YY 0793.2-2023 — Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water for haemodialysis and related therapies
YY 0793.2-2011 — Technical requirements of water treatment equipments for haemodialysis applications and related therapies - Part 2: For single-bed haemodialysis
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YY 0793.3-2023
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