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YY/T 1920-2023: Blood compatibility tests of haemodialysers
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| YY/T 1920-2023 | English | 239 |
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Blood compatibility tests of haemodialysers
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YY/T 1920-2023
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PDF similar to YY/T 1920-2023
Standard similar to YY/T 1920-2023 GB/T 26367 GB/T 26368 GB/T 26370 Basic data | Standard ID | YY/T 1920-2023 (YY/T1920-2023) | | Description (Translated English) | Blood compatibility tests of haemodialysers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 12,110 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the test method for hemocompatibility of dialyzers. This standard is applicable to the hemocompatibility test of medical devices such as hemodialyzers, hemofilters, and blood concentrators that use hollow fiber membranes as the main body. | YY/T 1920-2023: Blood compatibility tests of haemodialysers---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
CCSC50
Pharmaceutical Industry Standards of the People's Republic of China
Dialyzer hemocompatibility test
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction II
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Coagulation, platelets, complement system, and hematology tests of dialyzer 1
5 In vitro thrombosis test of dialyzers3
6 Hemolysis test of dialyzer 5
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.
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. China Institute of Food and Drug Control, Guangdong Medical Device Quality Supervision and Inspection Institute, Henan Pharmaceutical and Medical Device
Mechanical Inspection Institute.
The main drafters of this document. Xu Jianxia, Yang Wenrun, Yang Lifeng, Liu Kangbo, Mo Xiaoyan, Meng Xing, Luo Jiewei, Tian Liyan.
Introduction
Dialyzers are suitable for patients with acute and chronic renal failure and are used to carry out routine hemodialysis, hemodiafiltration and other treatments in medical institutions.
Treatment, repeated contact with circulating blood over a large area and for a long time, and is widely used in clinical applications. The evaluation of its blood compatibility is of great significance.
GB/T 16886.4 gives the guiding principles for hemocompatibility testing. Based on this principle, this document gives specific test results for hemocompatibility of dialyzers.
Physical testing methods.
GB/T 16886.4 requires comprehensive testing of the hemocompatibility of dialyzers, including. coagulation, platelets, complement system, blood
, thrombosis and hemolysis. The hemolysis test can reflect the potential damaging effect of the dialyzer on red blood cells, which is further clarified and optimized in this document.
Hemolysis test method for dialyzers. This document includes three parts. 1.Coagulation, platelets, complement system, and hematology tests of dialyzer;
2.In vitro thrombosis test of dialyzer; 3.Hemolysis test of dialyzer.
Dialyzer hemocompatibility test
1 Scope
This document specifies test methods for hemocompatibility of dialyzers.
This document applies to the hemocompatibility of medical devices such as hemodialyzers, hemofilters, and hemoconcentrators that use hollow fiber membranes as the main body.
sexual experimentation.
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.
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process
GB/T 16886.4 Biological evaluation of medical devices Part 4.Selection of tests for interaction with blood
GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials
3 Terms and definitions
The terms and definitions defined in GB/T 16886.1, GB/T 16886.4 and GB/T 16886.12 apply to this document.
4 Coagulation, platelet, complement system, and hematology tests of dialyzer
4.1 Overview
The main content of this chapter is the coagulation, platelet, complement system, and hematology test methods of the hollow fiber core component of the dialyzer. dialyzer
For the test methods of other components, such as end caps, sealing glue, etc., each component can be taken in proportion and refer to the methods in this document. as needed, also
Plasma can be used to test coagulation, and serum can be used to test complement system activation.
The hollow fiber flushing method in the following method is suitable for dialyzers without preservation fluid. For product comparison, select dialyzers without preservation fluid. Inside
Dialyzers with a preservation solution can be pre-flushed and tested according to the clinical use method. There is no need to flush again. The product comparison should use a preservation solution that contains the solution.
of dialyzer.
4.2 Test principle
After the anticoagulated fresh blood is gently and dynamically contacted with the hollow fiber membrane in vitro for a certain period of time, coagulation, platelets, and complement are detected.
Systemic and hematological changes.
4.3 Reagents and test control materials
4.3.1 Reagents
0.9% sodium chloride solution, 3.8% sodium citrate solution, snake venom factor, reagents for blood cell analyzer, prothrombin time
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