YY/T 1620-2018 English PDF

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YY/T 1620-2018: Cardiopulmonary bypass systems--Assessment method of red blood cell damage in continuous flow blood pumps
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Basic data

Standard ID: YY/T 1620-2018 (YY/T1620-2018)
Description (Translated English): Cardiopulmonary bypass systems--Assessment method of red blood cell damage in continuous flow blood pumps
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 15,118
Date of Issue: 2018-09-28
Date of Implementation: 2019-10-01
Regulation (derived from): State Drug Administration Announcement No. 72 of 2018
Issuing agency(ies): State Drug Administration

YY/T 1620-2018: Cardiopulmonary bypass systems--Assessment method of red blood cell damage in continuous flow blood pumps

---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.
Cardiopulmonary bypass systems--Assessment method of red blood cell damage in continuous flow blood pumps ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Cardiopulmonary bypass system continuous blood pump red blood cell injury Evaluation method Published on.2018-09-28 2019-10-01 implementation State Drug Administration issued

Content

Foreword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General 2 5 Test Overview 2 6 Preparation before the test 3 7 Test step 4 8 Acceptance of criteria 5 Appendix A (Normative Appendix) Selection of blood for blood pump red blood cell injury test in vitro 6 Appendix B (informative) Determination of plasma free hemoglobin and total hemoglobin 8 Reference 11

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. China Food and Drug Control Research Institute, Guangdong Medical Device Quality Supervision and Inspection Institute, Weihai Weigao Life Technology Limited. The main drafters of this standard. Shao Anliang, Yang Lifeng, Xu Liming, Xiang Guomin, Li Mengjie, He Xiaofan, Ke Jun, Hong Liangtong, Cao Suilan, Zheng Baoting, Xiang Jian.

Introduction

The purpose of using a blood pump is to replace or assist the function of the human heart to complete the extracorporeal circulation. Currently developed for roller pumps (roler Pump) and centrifugal pumps (centrifugalpumps) are continuous blood flow pumps commonly used in clinical extracorporeal circulation. Blood pump not only used in routine In cardiopulmonary bypass (extracorporeal circulation) for cardiac surgery, it can also be used for ventricular assist, extracorporeal membrane oxygenation, and the like. Hemolysis is one of the important parameters for evaluating red blood cell damage caused by blood pumps. Hemolysis caused by blood pump depends mainly on the design and knot of the blood pump Structure and materials used. The International Organization for Standardization Surgical Implants Technical Committee Cardiovascular Subcommittee (ISO /TC150/SC2) has been issued Cloth ISO 18242.2016 Cardiovascularimplantsandextracorporealsystems-Centrifugalbloodpumps, In the terms of the requirements and methods, there is a special evaluation requirement for red blood cell damage, and the basic conditions of blood for testing (blood flow) Rate, blood glucose, hemoglobin content); in the test procedure clause, the basic composition, test time, sampling point and test of the test tooling are given. Project (including detection indicators for free hemoglobin). However, the hemolysis performance evaluation was not included in the relevant blood pump standards in China. In the evaluation of the potential risk of blood pump, it undoubtedly left a safety hazard to the use. And in GB/T 16886.4 "Medical Device Biology Review Price Part 4. Selection of Tests for Interaction with Blood does not address fluid dynamics factors in continuous circulation of instruments such as blood pumps, Structure and other potential damage to red blood cells. Therefore, it is very necessary to establish a standardized in vitro hemolysis test for evaluating continuous blood flow pumps. law. Although the basic conditions for blood for testing are given in the ISO 18242 standard, detailed blood selection criteria for testing are not given. thing In fact, the different blood quality used for the test will seriously affect the results of the test; the detailed test tool design and continuous are not given in the standard. The test method of the flow cycle 6h. ASTM F1830-1997 (R2013) Standard Practice for Assessment of HemolysisinContinuousFlowBloodPumps and ASTMF1841-1997(R2013)StandardPracticefor SelectionofBloodforinvitroEvaluationofBloodPumps gives detailed test blood selection conditions and specific Test tool design and continuous cycle 6h test method. This standard optimizes the design of the test tooling and supplements the free hemoglobin. The test method improves the test procedure. Cardiopulmonary bypass system continuous blood pump red blood cell injury Evaluation method

1 Scope

This standard gives a specific method for evaluation of red blood cell damage in continuous blood pump. This standard is applicable to the evaluation of red blood cell injury in continuous blood flow pump (nominally 5L/min or more) in cardiopulmonary bypass system.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood (GB/T 16886.4- 2003, ISO 10993-4.2002, IDT)

3 Terms and definitions

The following terms and definitions as defined in GB/T 16886.4 apply to this document. 3.1 Continuous blood flow pump continuousflowbloodpump A device that produces a continuous flow of blood driven by a driving force. 3.2 Plasma free hemoglobin freeplasmahemoglobin Red blood cells destroy hemoglobin (globin or heme containing protein) released into the plasma. 3.3 Hemolysis hemolysis Destruction of red blood cell damage, leading to the phenomenon of hemoglobin entering the plasma. 3.4 Standard hemolysis index normalizedindexofhemolysis; NIH The amount of plasma free hemoglobin (g) increased per pump of 100 L of blood, corrected for plasma volume by hematocrit, and Corrected with flow rate and cycle time. 3.5 Standard millimeter hemolysis index normalizedmiligramindexofhemolysis;mg.NIH A standard milligram of hemolysis index expressed as milligrams of plasma free hemoglobin. 3.6 Modified hemolysis index modifiedindexofhemolysis; MIH The ratio of the amount of hemoglobin released into the plasma to the normalized total amount of hemoglobin delivered by the blood pump. ......

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