GB/T 43050-2023 English PDFUS$1459.00 ยท In stock
Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 43050-2023: Preparation and quality management of fluids for haemodialysis and related therapies - General requirements Status: Valid
Basic dataStandard ID: GB/T 43050-2023 (GB/T43050-2023)Description (Translated English): Preparation and quality management of fluids for haemodialysis and related therapies - General requirements Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 73,742 Date of Issue: 2023-09-07 Date of Implementation: 2025-04-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 43050-2023: Preparation and quality management of fluids for haemodialysis and related therapies - General requirements---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. ICS 11.040.40 CCSC45 National Standards of People's Republic of China Preparation of fluids for hemodialysis and related treatments and general requirements for quality management Published on 2023-09-07 2025-04-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee Table of contentsPreface III Introduction IV 1 Scope 1 1.1 General 1 1.2 Scope of application1 1.3 Not applicable scope 1 2 Normative reference documents 1 3 Terms and Definitions 2 4 Quality requirements 7 4.1 General 7 4.2 Dialysis water7 4.3 Requirements for concentrates10 4.4 Dialysate requirements10 4.5 Record retention11 5 Key points in system design 11 5.1 General 11 5.2 Technical aspects 11 5.3 Microbiological aspects 12 5.4 Environmental impact12 6 System performance confirmation 12 6.1 General 12 6.2 Confirm plan 13 6.3 Installation and operation confirmation 14 6.4 Performance Confirmation 14 6.5 Routine monitoring and revalidation14 7 Quality Management15 7.1 General 15 7.2 Liquid quality monitoring15 7.3 Monitoring of water treatment equipment 16 7.4 Monitoring of dialysis water storage and distribution18 7.5 Monitoring of concentrate preparation 19 7.6 Monitoring of concentrate distribution20 7.7 Monitoring of dialysate ratio 20 8 Microbial Control Methods 20 8.1 General 20 8.2 Disinfection 20 8.3 Microbiological monitoring methods 22 9 Location and access of water treatment systems 24 10 people 25 Appendix A (informative) Basis for the formation and provision of technical terms 26 A.1 General 26 A.2 Chemical pollutants 26 A.3 Microbial contaminants26 A.4 Requirements for concentrates26 A.5 Microbial contaminants in dialysate26 A.6 Monitoring of carbon media 27 A.7 Microbial Control Plan 27 A.8 Heterotrophic bacteria plate count 27 A.9 Culture conditions 28 A.10 Bacterial endotoxin test 29 Appendix B (informative) Equipment 30 B.1 General 30 B.2 Water treatment system30 B.3 Dialysis water storage and distribution35 B.4 Concentrate preparation 37 B.5 Concentrate storage and distribution40 B.6 Dialysate ratio 41 B.7 Centralized dialysate supply system 43 Appendix C (informative) Water treatment equipment, distribution system and dialysate monitoring principles 44 C.1 Monitoring system 44 C.2 Cleaning/Disinfection Strategy 46 Appendix D (Informative) Microbial Control Strategies 48 D.1 General 48 D.2 Microbial monitoring methods 49 D.3 Interpretation of microbiological monitoring results51 Appendix E (Informative) Confirmation 54 E.1 General 54 E.2 Confirmation Procedure 54 E.3 Monitoring results55 Appendix F (informative) Special considerations for home hemodialysis 56 F.1 General 56 F.2 Dialysate quality56 F.3 Facility Requirements56 F.4 Environment 57 F.5 Equipment 57 F.6 Concentrate 59 F.7 Monitoring 59 F.8 Personnel 60 Appendix G (informative) Special precautions for acute hemodialysis 61 G.1 Overview 61 G.2 Liquid quality 61 G.3 Equipment 61 G.4 Microbiological control methods 63 Reference 65ForewordThis 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. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158). This document was drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Weigao Blood Purification Products Co., Ltd., Bain Medical Medical Equipment (Guangzhou) Co., Ltd., Guangzhou Kangsheng Biotechnology Co., Ltd., Beijing Mailing Medical Technology Development Co., Ltd., Fresenius Pharmaceutical Research and Development (Shanghai) Co., Ltd. The main drafters of this document. He Xiaofan, Hu Xianghua, Xu Suhua, Wu Shaohai, Xie Yan, Huang Minju, Fu Yinbo, Jiang Shunzhong, Yang Zhenggen, Tong Kai, Huang Yang, Shi Zhenwei, Yin Lianghong, Lu Hansheng, Wen Shaojun, Tu Rong.IntroductionThis 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 management1 Scope1.1 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, systems and solutions for peritoneal dialysis.2 Normative reference documentsThe 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) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 43050-2023_English be delivered?Answer: Upon your order, we will start to translate GB/T 43050-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 9 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 43050-2023_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 43050-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
