YY/T 1631.1-2018 English PDFUS$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1631.1-2018: Compatibility determination of the transfusion sets with blood components - Part 1: Assessment of blood component depletion Status: Valid
Basic dataStandard ID: YY/T 1631.1-2018 (YY/T1631.1-2018)Description (Translated English): Compatibility determination of the transfusion sets with blood components - Part 1: Assessment of blood component depletion Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 8,883 Date of Issue: 2018-12-20 Date of Implementation: 2020-01-01 Quoted Standard: GB 18469 Regulation (derived from): State Drug Administration Announcement No. 97 of 2018 Issuing agency(ies): State Drug Administration Summary: This standard specifies the method for assessing the residual of blood components (red blood cells, platelets, and fresh frozen plasma) in a blood transfusion device after blood transfusion in a blood donor biocompatibility evaluation. This standard is applicable to the evaluation of the compatibility of blood transfusion devices with blood components. YY/T 1631.1-2018: Compatibility determination of the transfusion sets with blood components - Part 1: Assessment of blood component depletion---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. (Blood donors - Determination of compatibility of blood components - Part 1) ICS 11.040.20 C31 People's Republic of China Pharmaceutical Industry Standard Blood donor and blood component compatibility determination Part 1. Assessment of blood component residues Part 1.Assessmentofbloodcomponentdepletion Published on.2018-12-20 2020-01-01 implementation State Drug Administration issued ForewordYY/T 1631 "Determination of the compatibility of blood transfusion and blood components" is divided into the following two parts. --- Part 1. Assessment of blood component residues; --- Part 2. Assessment of blood component damage. This part is the first part of YY/T 1631. This part is 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 part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Institute of Blood Transfusion, Chinese Academy of Medical Sciences. The main drafters of this section. Qiao Chunxia, Zhao Zenglin, Wang Hong, Zhong Rui.IntroductionGB 8369 requires that the blood transfusion device be rated for the recommended range of blood components to ensure that the blood transfusion device is relevant to each blood component. The residue of the component does not exceed 5% of an adult therapeutic dose. Only specific requirements are given in the standard, but no specific test methods are specified. The purpose of this section of YY/T 1631 is to design a protocol to assess the loss of blood components after passing through the blood transfusion device. can be used as A supplement to GB 8369 for evaluating the residual of blood components as they flow through a blood transfusion device. The blood transfusion device can be used for the infusion of blood cell components and blood plasma components. Possible factors affecting the function of the blood transfusion include long liquid lines Degree, flow rate and characteristics, void volume and selected materials. The design and processing of the filter in the drip bucket is particularly important. Significant sources of variation include material source, surface area and characteristics, wire diameter, mesh size and homogeneity. This section of YY/T 1631 The method for assessing blood component residues can be used to evaluate the compatibility of blood transfusion devices with blood components. Blood donor and blood component compatibility determination Part 1. Assessment of blood component residues1 ScopeThis part of YY/T 1631 specifies the blood components (red fines) used in the blood donor biocompatibility evaluation to detect the flow through the blood transfusion device. Method for assessing residues in cells, platelets, and fresh frozen plasma in a blood transfusion device. This section applies to the evaluation of the compatibility of blood transfusion devices with blood components.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 18469 Whole blood and component blood quality requirements Pharmacopoeia of the People's Republic of China (four)3 component blood collection and storage3.1 General This section recommends the use of component blood within the shelf life but close to the end of the shelf life, 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 according to 3.2~3.4. 3.2 red blood cell component blood Red blood cell components (redcelscomponents, RCC) are stored in the red blood cell maintenance solution. An adult therapeutic dose of red blood cells Component blood refers to suspended red blood cells prepared from 2 units of whole blood [(400 ± 40) mL, without anticoagulant]. For before flowing through the blood transfusion device The red blood cell component usually requires a hemoglobin value of >18 g/unit. 3.3 platelet concentrate Platelet concentrates (PCs) were stored at 22 ° C with shaking. An adult therapeutic dose of platelet concentrate Refers to 1 unit of apheresis platelets or 10 units of mixed concentrated platelet suspension (concentrated platelets prepared from 10 units of whole blood). Correct The platelet component blood before flowing through the blood transfusion device usually requires a platelet count of > 2.4 x 1011 cells per unit. 3.4 Fresh frozen plasma Fresh frozen plasma (frsefrozenplasma, FFP) was thawed in a constant temperature water bath at 37 °C. An adult treatment dose FFP refers to Fresh frozen plasma prepared in 2 units of whole blood [(400 ± 40) mL, without anticoagulant]. Fresh frozen before flowing through the blood transfusion device Plasma typically requires a Factor VIII (FVIII) concentration of >0.7 IU/mL. Note. “An adult therapeutic dose” is derived from GB 8369. It can also be used to separate red fines from 1 unit of whole blood [(200±20) mL, without anticoagulant]. Cell suspension or fresh frozen plasma. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1631.1-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 1631.1-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1631.1-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1631.1-2018_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. 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