YY/T 1631.2-2020 English PDFUS$299.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1631.2-2020: Compatibility determination of the transfusion sets with blood component - Part 2: Assessment of damage to blood component Status: Valid
Basic dataStandard ID: YY/T 1631.2-2020 (YY/T1631.2-2020)Description (Translated English): Compatibility determination of the transfusion sets with blood component - Part 2: Assessment of damage to blood component Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 16,179 Date of Issue: 2020-09-27 Date of Implementation: 2021-09-01 Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration Issuing agency(ies): State Drug Administration YY/T 1631.2-2020: Compatibility determination of the transfusion sets with blood component - Part 2: Assessment of damage to blood component---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. Compatibility determination of the transfusion sets with blood component - Part 2.Assessment of damage to blood component People's Republic of China Pharmaceutical Industry Standards Compatibility determination of blood transfusion set and blood components Released on 2020-09-27 Implementation of 2021-09-01 Issued by the National Medical Products Administration ForewordYY/T 1631 "Determination of Compatibility of Blood Transfusion Set and Blood Components" is divided into the following two parts. ---Part 1.Assessment of residual blood components; ---Part 2.Assessment of blood component damage. This part is part 2 of YY/T 1631. This section 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 agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106). Drafting organizations of this section. Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Shandong Medical Device Product Quality Inspection Center. The main drafters of this section. Wang Hong, Qiao Chunxia, Zhong Rui, Zhao Zenglin, Xu Ming, Zhou Yaru.IntroductionGB 8369 requires that the blood transfusion set be evaluated according to the recommended range of blood components to ensure that the blood transfusion set does not show any blood components. Damage (or if applicable, activated or not activated). The standard only recommends that the assessment should use a confirmed test method for the flow through the blood transfusion set The blood component samples before and after were compared, but no specific test method was specified. This section gives test methods to evaluate the flow through the blood transfusion set The damage of blood components before and after can be used as a supplement to GB 8369. The blood transfusion set can be used for the transfusion of blood cell components and plasma components. Possible factors that affect the function of the blood transfusion set include the length of the fluid line Degree, flow rate and characteristics, void volume and selected materials. The design and processing of the filter in the drip bucket are particularly important. The major sources of variation include material source, surface area and characteristics, wire diameter, mesh size and uniformity. Compatibility determination of blood transfusion set and blood components1 ScopeThis part of YY/T 1631 specifies the detection of blood components (red blood cells, red blood cells, Platelets and fresh frozen plasma) damage assessment methods. This section is suitable for evaluating the compatibility of blood transfusion sets with blood components.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB 18469 quality requirements for whole blood and blood components YY 0329-2009 Single-use leukocyte-removing filter YY/T 12862-2016 Platelet storage bag performance Part 2.Guidelines for evaluating platelet storage performance3 Collection and storage of blood components3.1 General This section recommends the use of blood components within the shelf life but near the end of the shelf life, and should meet the requirements of GB 18469.Red blood cell component blood, The collection and storage of platelet concentrate and fresh frozen plasma should be carried out in accordance with 3.2 to 3.4 respectively. In addition to meeting the requirements of 3.2 to 3.4, the detection indicators of each blood component should also be in the corresponding reference value range or reagent detection range. 内内。 In the enclosure. 3.2 Red blood cell component blood Red blood cell components (RedCelsCompoints, RCC) are stored in the red blood cell maintenance solution. One adult therapeutic dose of red powder Cytoplasmic blood refers to suspended red blood cells separated and prepared from 2 units of whole blood (400mL ± 40mL, without anticoagulant). For blood transfusion The red blood cell component blood in front of the organ usually requires a hemoglobin value > 18g/unit. 3.3 Platelet concentrate Platelet concentrates (Platelet Concentrates, PCs) were stored at 22°C with shaking. An adult therapeutic dose of platelet concentrate Liquid refers to 1 unit of apheresis platelet or 10 units of mixed platelet concentrate (platelet concentrate prepared from 10 units of whole blood). for The platelet component blood before flowing through the blood transfusion device usually requires the number of platelets >2.4×1011/unit. 3.4 Fresh frozen plasma Fresh frozen plasma (FreshFrozen Plasma, FFP) was thawed in a 37°C constant temperature water bath. An adult therapeutic dose FFP refers to Fresh frozen plasma prepared from 2 units of whole blood (400mL ± 40mL, without anticoagulant). For the freshness before flowing through the blood transfusion set Frozen plasma usually requires coagulation factor Ⅷ. C >0.7 IU/mL. Note. "One adult therapeutic dose" is derived from GB 8369, and red blood cell suspension isolated from 1 unit of whole blood (200 mL, without anticoagulant) can also be used Or fresh frozen plasma.4 Test materials4.1 Suitable for quality control products or other reference products for calibration of blood cell analyzers, electrolyte analyzers, spectrophotometers, and microplate readers. 4.2 It is suitable for pH meter, blood gas analyzer, flow cytometer and other calibration quality control products or other reference products. 4.3 Reagents required for the determination of red blood cell component blood, platelet concentrate and fresh frozen plasma related indicators.5 Apparatus and test equipmentPlatelet storage box, constant temperature water bath, blood cell analyzer, spectrophotometer, microplate reader, electrolyte analyzer, flow cytometer, pH meter, blood gas analyzer, centrifuge, pipette, plastic test tube, etc.6 Preparation before the test6.1 Sample preparation Gravity blood transfusion set. Use the infusion stand to adjust the height of the blood transfusion set, so that the blood components flow through the blood transfusion set under a static pressure difference of 1m. Pressure type blood transfusion set. set the relevant parameters of the pump according to the product manual. Note. In order to facilitate the analysis of the results, at least 3 sets of tests for each product are tested in parallel. 6.2 Instrument preparation Initialize the blood cell analyzer, flow cytometer, microplate reader, etc. and perform self-checking for use. 6.3 Preparation of blood components before and after treatment The stored component blood is taken out, and 10 mL of blood is taken as the component blood before flowing through the blood transfusion set. Follow the instructions in the manufacturer's instructions Methods The puncture of the blood transfusion device is pierced into the blood transfusion socket of the blood bag, and the blood components are caused to flow through the blood transfusion device under gravity or pressure. Take the emptied unused blood bag and collect the blood components flowing through the blood transfusion set.7 Determination of red blood cell components7.1 Determination of free hemoglobin 7.1.1 Test principle Hemoglobin is a colored protein with a molecular weight of 64.458KD. The color develops after the oxidation of o-tolidine, and the color reaction is divided into two phases. The first-stage oxidation product is blue, the reaction proceeds at about pH 4.6, and the absorption peak is at 630 nm. The second-stage oxidation product is yellow and reacts in The pH is 1.5, and the absorption peak is at 435 nm. 7.1.2 Test equipment and reagents 7.1.2.1 Test equipment Constant temperature water bath, spectrophotometer, centrifuge, etc. 7.1.2.2 Test reagent O-tolidine solution (weigh 0.25 g of o-tolidine, dissolve it in 90 mL of glacial acetic acid, and dilute to 100 mL with distilled water. It can be stored in the refrigerator for 8 to 12 weeks. The color will gradually darken during the storage period. If the color is too dark, it should be reconstituted), 1% hydrogen peroxide solution Solution (freshly prepared), 10% acetic acid solution, hemoglobin (Hb) standard solution. 7.1.3 Sample preparation 7.1.4 Detection Measure according to the method in Appendix G of YY 0329-2009. Note. Depending on the actual situation, it may be necessary to properly dilute the test sample, and other verified equivalent test methods may be used. 7.1.5 Test results Calculate and record the free hemoglobin content in the upper plasma of the red blood cell components before and after flowing through the blood transfusion device, and evaluate before flowing through the blood transfusion device After the red blood cell damage. 7.2 Determination of potassium ion (K+) 7.2.1 Test principle The principle of ion selective electrode method (ISE) is an electrochemical technique that uses the relationship between electrode potential and ion activity to determine ion activity. The core of this technique is the use of a sensitive membrane that selectively responds to the measured ion. The potassium electrode adopts a neutral carrier membrane containing valinomycin, which is suitable for K+ There is a high degree of selectivity. When the selected ion is in contact with the ISE electrode film, the electromotive force in the potentiometer circuit changes immediately, resulting in Health potential difference. The magnitude of the potential difference is proportional to the activity of potassium ions in the solution and also proportional to the ion concentration. 7.2.2 Test equipment and reagents 7.2.2.1 Test equipment Electrolyte analyzer. 7.2.2.2 Test reagent The main components of ISE diluent are bis(2-hydroxyethyl)amino(trihydroxymethyl)methane (Bis-Tris), boric acid, and formaldehyde solution. The main component of ISE reference electrode solution is potassium chloride. The main components of the ISE internal standard solution are Bis-Tris, boric acid, sodium chloride, potassium dihydrogen phosphate and sodium bicarbonate. Note. Please refer to the reagent manual of each manufacturer for details. 7.2.3 Sample preparation Same as 7.1.3. 7.2.4 Detection 7.2.4.1 Turn on the instrument and clean the pipeline. 7.2.4.2 Instrument calibration Use low- and high-value calibration solutions suitable for this instrument to determine the slope value of the potassium and sodium electrode, and then use a blood sample of known concentration The calibration product is calibrated and verified, the compensation value of the standard curve is calculated, and the instrument automatically adds the compensation value (after daily calibration, the slope and compensation of the standard curve The value should be within the allowable range of the instrument). 7.2.4.3 After the calibration is passed, at least 2 quality control products at the concentration level should be made. After the quality control is passed, the samples should be tested. 7.2.4.4 The measurement results are calculated by the microprocessor in the instrument and then printed out. 7.2.4.5 After using up every day, clean the electrodes and pipes before turning off the machine. Note. According to actual conditions, other proven equivalent test methods can be used. 7.2.5 Test results Record the potassium ion content in the upper plasma of the red blood cell components before and after the blood transfusion device, and evaluate the red blood cell damage before and after the blood transfusion Injury situation. 8.Determination of Platelet Concentrate 8.1 Supernatant lactate dehydrogenase (LDH) 8.1.1 Test principle Serum lactate dehydrogenase (LDH) catalyzes the oxidation of L-lactic acid to pyruvate and at the same time transfers hydrogen to oxidized nicotinamide adenine dinucleoside Acid (NAD+), to generate reduced nicotinamide adenine dinucleotide (NADH). NADH has strong absorption at the wavelength of 340nm, while NAD+ has no absorption. In the case of excess substrate, the rate of NADH production is proportional to the serum LDH concentration, so it can be monitored NADH rises to determine the serum LDH activity concentration. The reaction formula of LDH activity determination is as follows. L-lactic acid＋NAD＋ →LDH← Pyruvate＋NADH＋H＋ 8.1.2 Test equipment and reagents 8.1.2.1 Test equipment Constant temperature water bath, spectrophotometer or microplate reader. 8.1.2.2 Test reagent LDH kit. 8.1.3 Sample preparation 8.1.4 Testing press... ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1631.2-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1631.2-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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