GB/T 43050-2023Preparation and quality management of fluids for haemodialysis and related therapies - General requirements (English PDF)
血液透析和相关治疗用液体的制备和质量管理 通用要求
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
September 7, 2023
Implementation date
April 1, 2025
Scope
GB/T 43050-2023 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 通用要求.
GB/T 43050-2023 — This document is the basic standard for a series of standards for water treatment equipment, water, dialysis water, concentrates and dialysate, and provides dialysis professionals with blood Requirements related to the preparation of fluids for dialysis and related treatments.
This document does not cover clinical issues related to improper use of water, dialysis water, concentrates or dialysates.
Participating in renal replacement therapy Medical professionals should refer to the application of the fluid (such as hemodialysis, hemodiafiltration, high-flux hemodialysis, etc.) to make final decisions and understand Risks that may arise if the quality of the fluid in each treatment modality does not meet the requirements.
The concepts described in this document may change as technology develops. The requirements and recommendations put forward in the standard should be reviewed regularly for further Learn more about the role of dialysate purity in patient outcomes and the development of new technologies.
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Document preview — GB/T 43050-2023
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 1.1 General
- 1.2 Scope of application
- 1.3 Not applicable scope
- 2 Normative reference documents
- 3 Terms and Definitions
- 4 Quality requirements
- 4.1 General
- 4.2 Dialysis water
- 4.3 Requirements for concentrates
- 4.4 Dialysate requirements
- 4.5 Record retention
- 5 Key points in system design
- 5.1 General
- 5.2 Technical aspects
- 5.3 Microbiological aspects
- 5.4 Environmental impact
- 6 System performance confirmation
- 6.1 General
- 6.2 Confirm plan
- 6.3 Installation and operation confirmation
- 6.4 Performance Confirmation
- 6.5 Routine monitoring and revalidation
- 7 Quality Management
- 7.1 General
- 7.2 Liquid quality monitoring
- 7.3 Monitoring of water treatment equipment
- 7.4 Monitoring of dialysis water storage and distribution
- 7.5 Monitoring of concentrate preparation
- 7.6 Monitoring of concentrate distribution
- 7.7 Monitoring of dialysate ratio
- 8 Microbial Control Methods
- 8.1 General
- 8.2 Disinfection
- 8.3 Microbiological monitoring methods
- 9 Location and access of water treatment systems
- 10 People
- Appendix A (informative) Basis for the formation and provision of technical terms
- A.1 General
- A.2 Chemical pollutants
- A.3 Microbial contaminants
- A.4 Requirements for concentrates
- A.5 Microbial contaminants in dialysate
- A.6 Monitoring of carbon media
- A.7 Microbial Control Plan
- A.8 Heterotrophic bacteria plate count
- A.9 Culture conditions
- A.10 Bacterial endotoxin test
- Appendix B (informative) Equipment
- B.1 General
- B.2 Water treatment system
- B.3 Dialysis water storage and distribution
- B.4 Concentrate preparation
- B.5 Concentrate storage and distribution
- B.6 Dialysate ratio
- B.7 Centralized dialysate supply system
- Appendix C (informative) Water treatment equipment, distribution system and dialysate monitoring principles
- C.1 Monitoring system
- C.2 Cleaning/Disinfection Strategy
- Appendix D (Informative) Microbial Control Strategies
- D.1 General
- D.2 Microbial monitoring methods
- D.3 Interpretation of microbiological monitoring results
- Appendix E (Informative) Confirmation
- E.1 General
- E.2 Confirmation Procedure
- E.3 Monitoring results
- Appendix F (informative) Special considerations for home hemodialysis
- F.1 General
- F.2 Dialysate quality
- F.3 Facility Requirements
- F.4 Environment
- F.5 Equipment
- F.6 Concentrate
- F.7 Monitoring
- F.8 Personnel
- Appendix G (informative) Special precautions for acute hemodialysis
- G.1 Overview
- G.2 Liquid quality
- G.3 Equipment
- G.4 Microbiological control methods
- Reference
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.
This document has been modified to adopt ISO 23500-1:2019 "Preparation and quality management of hemodialysis and related treatment liquids - Part 1: General requirements" beg". Compared with ISO 23500-1:2019, the main technical differences between this document and ISO 23500-1:2019 are as follows.
---Added YY/T 0793.1-2022;
---Replaced ISO 23500-5 with normatively quoted YY/T 0793.4-2022 to adapt to my country's national conditions;
---Changed the expressions related to the disinfection process in 8.3.2.2 to adapt to domestic clinical practice;
---Deleted the content related to online preparation of replacement fluid and dialyzer reuse in ISO 23500-1:2019 to comply with relevant regulations in my country regulations;
---8.3.3.2.1, 8.3.3.3, 8.3.4, and relevant content from the "Pharmacopoeia of the People's Republic of China" have been added to A.10 in Appendix A to improve the applicability of the method in the country.
The following editorial changes have been made to this document.
---Change the name of the standard to "General Requirements for the Preparation and Quality Management of Hemodialysis and Related Therapeutic Fluids";
---Added 3.4 middle note and changed B.4.5 middle note;
---Deleted Note 2 in ISO 23500-1:2019 Terms and Definitions 3.30;
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
Introduction
This document is the basic standard for a series of standards for water treatment and dialysate production, providing users with information on water treatment, concentrate treatment and hemodialysis.
Guidance on the production and quality supervision of dialysate for use. The quality of dialysis fluids is the responsibility of dialysis professionals and is an important factor in daily hemodialysis safety.
It is the key to be fully effective, so it is necessary to provide relevant requirements.
Appendix A further explains the basis for the formation and provision of technical terms.
Under normal circumstances, the equipment used in the dialysate preparation stage is provided by professional suppliers, and the maintenance of the equipment after installation is performed by dialysis professionals.
members are responsible. This document provides quality monitoring and maintenance guidelines for equipment to ensure that dialysate quality remains stable and within an acceptable range. suggestion the user operates and maintains the equipment according to the instructions of the professional manufacturer. If there is no professional manufacturer, the user is responsible for ensuring that the equipment is used in the hemodialysis facility.
performance during installation, and appropriate operation and maintenance manuals should be available.
Appendix B provides further description of water treatment systems, concentrate preparation, and dialysate preparation in dialysis facilities for users to understand certain
It provides basic knowledge on the usage principles and configuration methods of some specific equipment rather than providing detailed design standards. Water treatment equipment is suitable for YY/T 0793.1-2022.
More and more integrated systems have been designed and validated for the production of dialysis water and dialysate, and may be used clinically. Made of independent accessories the assembled system is applicable to this document. The integrated system may not be applicable to some provisions in this document and YY/T 0793.1-2022.
model, but applicable to ISO 23500-3:2019, ISO 23500-4:2019 and YY/T 0793.4-2022.For consistency, such systems Use in accordance with the manufacturer's operating, testing and maintenance instructions to ensure the system operates under validated conditions.
Appendix C provides information on water treatment equipment, distribution systems, and dialysate monitoring principles, and Appendix D provides microbial control strategies.
Information related to the strategy, Appendix E provides information related to confirmation.
This document reflects the requirements of healthcare professionals, patients and medical device manufacturers for the production and monitoring of water treatment, concentrates, and dialysates in hemodialysis.
We have worked tirelessly on testing recommendations to protect hemodialysis patients from the adverse effects of inappropriate methods of preparing dialysate.
Impacts, including adverse effects caused by known chemical contaminants and microbial contaminants. Appendix F and Appendix G further describe family blood Special considerations for dialysis and acute hemodialysis. This document is applicable to those involved in the management of dialysis equipment and those who receive treatment with dialysis equipment.
The medical professional who performs day-to-day care is the person responsible for the final preparation of the dialysate. Doctors need to ensure that dialysate prescriptions are accurate and responsible for Responsible for compliance with applicable quality standards.
Preparation of fluids for hemodialysis and related treatments and general requirements for quality management
1 Scope
1.1 General
This document is the basic standard for a series of standards for water treatment equipment, water, dialysis water, concentrates and dialysate, and provides dialysis professionals with blood Requirements related to the preparation of fluids for dialysis and related treatments.
This document does not cover clinical issues related to improper use of water, dialysis water, concentrates or dialysates. Participating in renal replacement therapy Medical professionals should refer to the application of the fluid (such as hemodialysis, hemodiafiltration, high-flux hemodialysis, etc.) to make final decisions and understand Risks that may arise if the quality of the fluid in each treatment modality does not meet the requirements.
The concepts described in this document may change as technology develops. The requirements and recommendations put forward in the standard should be reviewed regularly for further Learn more about the role of dialysate purity in patient outcomes and the development of new technologies.
1.2 Scope of application
This document specifies the responsibilities of users of dialysis fluids after installation and delivery of dialysis fluid manufacturing equipment.
Dialysis fluids referred to in this document include.
a) Dialysis water used to prepare dialysate and replacement fluid (see 3.17);
b) Dialysis water used when preparing the concentrate at the user's facility;
c) Concentrates;
d) Final dialysate and replacement fluids.
The scope of application of this document includes.
a) Quality management of equipment handling and distributing water for dialysate/replacement fluid preparation, from the point where municipal water enters the dialysis facility to Stop where the dialysate finally enters the dialyzer or where the replacement fluid is injected;
b) Equipment for preparing concentrates in dialysis facilities using dry powders or other highly concentrated media;
c) The preparation process starting from dialysis water and concentrate to the final dialysate or replacement solution.
1.3 Inapplicable scope
This document does not apply to small volume dialysate regeneration and recirculation systems based on adsorption technology, continuous kidneys using prepackaged solutions Alternative therapy systems, and solutions for peritoneal dialysis.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations for undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.
YY/T 0793.1-2022 Preparation and quality management of hemodialysis and related therapeutic fluids Part 1: Hemodialysis and related treatments Regarding therapeutic water treatment equipment (ISO 23500-2:2019, MOD) YY/T 0793.4-2022 Preparation and quality management of hemodialysis and related therapeutic fluids Part 4: Hemodialysis and related treatments Regarding the quality of therapeutic dialysate (ISO 23500-5:2019, MOD)
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 65 pages — is available in the English PDF.
Referenced standards
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