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YY 0793.2-2023: Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water for haemodialysis and related therapies
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Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water for haemodialysis and related therapies
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YY 0793.2-2023
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| YY 0793.2-2011 | English | 559 |
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Technical requirements of water treatment equipments for haemodialysis applications and related therapies. Part 2: For single-bed haemodialysis
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YY 0793.2-2011
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Basic data | Standard ID | YY 0793.2-2023 (YY0793.2-2023) | | Description (Translated English) | Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water for haemodialysis and related therapies | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 18,114 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2026-12-01 | | Older Standard (superseded by this standard) | YY 0572-2015 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the minimum requirements for water used in the preparation of dialysis concentrates, dialysis fluids (for hemodialysis, hemodiafiltration or hemofiltration). This standard applies to water used in the preparation of dialysis concentrates and dialysis liquids (for hemodialysis, hemodiafiltration or hemofiltration). This standard does not cover the use of water treatment equipment and the operation of mixing the treated water with concentrate to produce the final dialysate. These operations are performed by dialysis professionals. This standard does not apply to dialysate regeneration systems. | YY 0793.2-2023: Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water for haemodialysis and related therapies
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ICS 11.040.40
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0572-2015
Fluids for hemodialysis and related treatments
Preparation and quality control Part 2.
Hemodialysis and related therapeutic water
Published on November 22, 2023, implemented on December 1, 2026
The State Drug Administration issued
Table of Contents
Preface I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test methods 3
Appendix A (Informative) Technical differences between this document and ISO 23500-3.2019 and their causes 5
Appendix B (Informative) Basic basis for the formation and regulation of this document 6
Reference 11
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is Part 2 of the Preparation and Quality Management of Fluids for Hemodialysis and Related Therapeutic Uses.
Preparation and Quality Management of Liquids has been published in the following sections.
--- Part 1.Water treatment equipment for hemodialysis and related treatments (YY/T 0793.1-2022);
--- Part 2.Water for hemodialysis and related treatments (YY 0793.2-2023);
--- Part 4.Quality of dialysate for hemodialysis and related therapies (YY/T 0793.4-2022).
This document replaces YY 0572-2015 "Water for Hemodialysis and Related Treatments". Compared with YY 0572-2015, in addition to structural adjustments and
In addition to editorial changes, the main technical changes are as follows.
--- Changed the scope (see Chapter 1, Chapter 1 of YY 0572-2015);
--- Deleted the terms and definitions of "intervention level", "total chlorine" and "dialysis water" (see 3.1 to 3.3 of YY 0572-2015);
--- Added quality requirements for dialysis water (see 4.1);
--- Added fungi requirements (see 4.2);
--- Deleted the requirements for dialysis water in hemodialysis machine reprocessing (see 4.2 of YY 0572-2015);
--- Added the maximum allowable amount and total chlorine explanation in Table 1 (see 4.3);
--- Deleted the verification and monitoring of dialysis water (see 5.1 of YY 0572-2015);
--- The microbiological detection method has been changed (see 5.1, 5.2 of YY 0572-2015);
--- Changed the analytical methods for some chemical pollutants (see 5.3, 5.3 of YY 0572-2015).
This document is modified to adopt ISO 23500-3.2019 “Preparation and quality management of fluids for hemodialysis and related therapies Part 3.Blood
Water for Dialysis and Related Therapeutic Use.
Compared with ISO 23500-3.2019, this document has the following structural adjustments.
--- Combine 4.2 "Chemical pollutant requirements" and 4.2.1 "General requirements" in ISO 23500-3.2019 and include them in 4.3 "Chemical
In the "Contaminant Requirements", the content of 4.2.2 Organic carbon, pesticides and other chemicals was deleted;
---Include 4.3 “Microbiological requirements” in ISO 23500-3.2019 in 4.2 “Microbiological requirements” of this document;
--- Combine 5.1 "Microbiological tests for dialysis water" and 5.2 "Microbiological content test methods" in ISO 23500-3.2019 and include
In 5.1 “Microbiological Detection Methods” of this document;
---Include 5.3 “Detection methods for chemical pollutants” in ISO 23500-3.2019 into 5.2 “Detection methods for chemical pollutants” in this document.
"Law";
--- Added Appendix A.
This document has many technical differences compared to ISO 23500-3.2019.
A list of technical differences and their causes is given in Appendix A.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2005 as YY 0572-2005, first revised in.2015;
---This is the second revision, and the standard number is changed to YY 0793.2-2023.
Introduction
"Preparation and Quality Management of Fluids for Hemodialysis and Related Therapeutics" consists of 4 parts.
--- Part 1.Hemodialysis and related treatment water treatment equipment. The purpose is to establish a single water treatment device and a
Or the requirements of a water treatment system consisting of multiple of these devices.
--- Part 2.Water for hemodialysis and related treatments. The purpose is to establish requirements for hemodialysis and related water.
--- Part 3.Concentrates for hemodialysis and related therapies. The purpose is to establish requirements for concentrates for hemodialysis and related therapies.
--- Part 4.Quality of dialysate for hemodialysis and related treatments. The purpose is to establish the quality of dialysate for hemodialysis and related treatments.
Require.
The quality of hemodialysis and related water is sufficient to ensure that hemodialysis, hemodiafiltration or hemofiltration can be carried out safely and effectively.
One of the most important aspects of.
This document contains the chemical composition of water used in the preparation of dialysis concentrates, dialysis fluids (for hemodialysis, hemodiafiltration or hemofiltration).
and microbiological minimum requirements, and the steps necessary to ensure compliance with these requirements.
Hemodialysis and related treatments, such as hemodiafiltration, expose patients to weekly exposure to the semipermeable membrane of the hemodialyzer or hemodiafiltration machine.
If the water intake exceeds 500L, and the oral intake of healthy individuals rarely exceeds 12L per week, this exposure increases by more than 40 times.
Control and regular monitoring are carried out to avoid excessive levels of known or suspected harmful substances.
Awareness of the harm is still growing, and drinking water treatment technology is still developing, so this document will continue to develop and improve.
The physiological effects of organic pollutants are an important area of research; however, the impact of such pollutants on patients undergoing routine dialysis treatment is largely unknown.
Therefore, the limit values of organic contaminants in water used for the preparation of dialysis fluid, concentrate and reprocessing of hemodialyzers are unknown.
Not specified in this document.
The final dialysate consists of concentrate or salts produced, packaged and labeled in accordance with ISO 23500-4 and water conforming to the requirements of this document.
Operation of water treatment equipment and hemodialysis systems for continuous monitoring of the quality of water used to prepare the dialysate and for the concentration and
Salt handling is the responsibility of the hemodialysis center and is covered in ISO 23500-1.
dialysis, hemodiafiltration, hemofiltration) and understand the risks of each application and the safety requirements for the fluids used in each application.
This document is addressed to manufacturers and suppliers of water treatment systems and hemodialysis facilities.
Fluids for hemodialysis and related treatments
Preparation and quality control Part 2.
Hemodialysis and related therapeutic water
1 Scope
This document specifies the minimum water concentrations for the preparation of dialysis concentrates and dialysis fluids (for hemodialysis, hemodiafiltration or hemofiltration).
Low requirements.
This document applies to water used in the preparation of dialysis concentrate and dialysis fluid (for hemodialysis, hemodiafiltration or hemofiltration).
This document does not cover the use of water treatment equipment and the mixing of treated water with concentrate to produce the final dialysate.
This document does not apply to dialysate regeneration systems.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 43050 General requirements for the preparation and quality management of fluids for hemodialysis and related treatments (GB/T 43050-2023,
ISO 23500-1.2019, MOD)
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The terms and definitions defined in GB/T 43050 apply to this document.
4 Requirements
4.1 Quality requirements for dialysis water
After the water treatment system is installed, the quality of the dialysis water should be verified in accordance with the provisions of 4.2 and 4.3.Thereafter, the dialysis water should be monitored regularly.
the quality of.
NOTE. This document assumes that the water supply used for treatment is potable water of acceptable quality. If the water supply comes from another source, such as a privately owned borehole or well, the sewage
Contaminant levels will not be as tightly controlled.
4.2 Microbiological requirements
The total microbial count in dialysis water should be less than 100 CFU/mL. This should be set based on an understanding of the microbial dynamics of the system.
An intervention level, which is usually 50% of the maximum permitted level.
Endotoxin levels in dialysis water should be less than 0.25 EU/mL. An intervention level should be established, usually 50% of the maximum permissible level.
Fungi (yeast and filamentous fungi) can coexist with bacteria and endotoxins in dialysis water, but fungi in hemodialysis water systems are
More research is needed into the role of steroids in biofilm formation and their clinical significance, therefore no maximum permissible limits have yet to be established.
NOTE See B.4 for the history of these requirements.
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