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GB 18469-2012: Quality requirements for whole blood and blood components Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 18469: Historical versions
Similar standardsGB 18469-2012: Quality requirements for whole blood and blood components---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB18469-2012GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.020 C 05 Replacing GB 18469-2001 Quality requirements for whole blood and blood components Issued on: MAY 11, 2012 Implemented on: JULY 01, 2012 Issued by. Ministry of Health of the People’s Republic of China; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 6 4 Blood safety testing requirements... 11 5 Blood quality control requirements... 12ForewordChapter 4 of this Standard is mandatory and the rest are recommended. This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces GB 18469-2001 Standards for whole blood and blood components quality. Compared with GB 18469-2001, the main technical changes are as follows. -- Change the English name from “Standards for whole blood and blood components quality” to “Quality requirements for whole blood and blood components”; -- Adjust the framework structure of the standard, by dividing the requirements for blood into two parts. blood safety testing requirements and blood quality control requirements; -- Add the definitions of whole blood leukocytes reduced, frozen red blood cells, fresh frozen plasma methylene blue treated and removed, frozen plasma and frozen plasma cryoprecipitate reduced, frozen plasma methylene blue treated and removed, pooled platelets, irradiated blood components and freezing; -- Revise the definitions of blood product, blood components, red blood cells components, apheresis components, whole blood, red blood cells, red blood cells in additive solution, washed red blood cells, deglycerolized red blood cells, platelets, fresh frozen plasma, cryoprecipitated antihemophilic factor, concentrated leukocyte-reduced red blood cells, suspended leukocyte-reduced red blood cells, apheresis platelets, apheresis leukocyte-reduced platelets, apheresis fresh frozen plasma and apheresis granulocytes; -- Change the name of “leukocyte-reduced blood products” in GB 18469-2001 to “blood products leukocytes reduced”; -- Add quality requirements for whole blood leukocytes reduced, red blood cells in additive solution leukocytes reduced, fresh frozen plasma methylene blue treated and removed, frozen plasma and frozen plasma cryoprecipitate reduced, frozen plasma methylene blue treated and removed and pooled platelets; -- Delete the relevant content of whole blood and component blood labels and connect with other relevant national standards; -- Add quality requirements for 300 mL whole blood and corresponding blood components; Quality requirements for whole blood and blood components1 ScopeThis Standard specifies the quality requirements for whole blood and blood components provided by general blood stations and used for clinical transfusion. This Standard applies to whole blood and blood components provided by general blood stations and used for clinical transfusion.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 14232.1, Plastics collapsible containers for human blood and blood components - Part 1.Conventional containers3 Terms and definitionsFor the purposes of this document, the terms and definitions given in GB 14232.1 and the following apply. 3.1 preservative solution A class of drugs with anticoagulants, glucose, etc. as main ingredients, used to prevent blood coagulation and maintain the activity and physiological functions of various components in the blood. 3.2 blood product A uniform product formed by mixing a certain amount of blood or blood components from qualified blood donors with a certain amount of preservative solution. 3.3 additive solution red blood cells leukocytes reduced The red blood cells components made by using a leukocyte filter to remove almost all leukocytes from red blood cells and making the number of leukocytes remaining in the red blood cells lower than a certain value; or the red blood cells components made by the remaining part after separating most of the blood plasma in the whole blood leukocytes reduced by using a multi-unit plastics container with a leukocyte filter to collect whole blood, and removing almost all leukocytes from the whole blood through the leukocyte filter. 3.11 red blood cells in additive solution The red blood cells components made by separating most of the blood plasma from the whole blood collected in a multi-link plastics container using a specific method, and adding red blood cell additive solution into the remainder. 3.12 red blood cells in additive solution leukocytes reduced The red blood cells components made by using a leukocyte filter to remove almost all leukocytes from red blood cells in additive solution and making the number of leukocytes remaining in the red blood cells in additive solution lower than a certain value; or the red blood cells components made by using a multi-unit plastics container with a leukocyte filter to collect whole blood, removing almost all leukocytes from the whole blood through the leukocyte filter, separating most of the blood plasma in the whole blood leukocytes reduced, and adding red cell additive solution to the remainder. 3.13 washed red blood cells The red blood cells components made by using a large amount of isotonic solution to wash the whole blood and red blood cells in additive solution within the storage period by a specific method to remove almost all blood plasma components and some non-red blood cell components, and suspending the red blood cells in sodium chloride injection or red blood cells in additive solution. 3.14 frozen red blood cells The red blood cells components made by separating red blood cells from whole blood or red blood cells in additive solution within 6 days of collection using a specific method, mixing it with glycerol of a certain concentration and volume, and quickly The blood components, in solid state by quick freezing, made by separating the blood plasma from the whole blood which is stored in a refrigerated environment, preferably within 6 hours (ACD as preservative solution) or 8 hours (CPD or CPDA-1 as preservative solution) after collection, but not more than 18 hours. 3.21 fresh frozen plasma methylene blue treated and removed The blood components, in solid state by quick freezing, made by collecting the whole blood stored in a refrigerated environment, separating the blood plasma according to the requirements of 3.20, and using the methylene blue virus inactivation technology for virus inactivation before quick freezing. 3.22 apheresis fresh frozen plasma The apheresis components made by using a blood cell separator to automatically separate the blood plasma from the blood of qualified blood donors under fully closed conditions and quickly freezing it into a solid state within 6 hours. 3.23 frozen plasma and frozen plasma cryoprecipitate reduced The blood components made by separating the blood plasma from the whole blood within the valid period by a specific method and quickly freezing it into solid state; or the blood components made by separating the cryoprecipitated antihemophilic factor from fresh frozen plasma and quick freezing the remaining part into solid state. 3.24 frozen plasma methylene blue treated and removed The blood components made by virus-inactivating and quick-freezing into solid state of the blood plasma separated from the whole blood within the valid period OR the remaining blood plasma after reducing the cryoprecipitated antihemophilic factor from the fresh frozen plasma by using the methylene blue virus inactivation technology. 3.25 cryoprecipitated antihemophilic factor The blood components made by using a specific method to thaw the fresh frozen plasma within the storage period at 1 °C ~ 6 °C, separating most of the blood plasma, and quick- freezing the remaining cold insoluble substances into solid state within 1 hour. 3.26 apheresis granulocytes The apheresis components made by using a blood apheresis machine to automatically separate the granulocytes from the blood of qualified blood donors under fully closed conditions and suspending them in a certain amount of blood plasma. 3.27 irradiated blood components The blood components made by using γ-rays at an intensity of 25Gy ~ 30Gy to irradiate blood products, so as to inactivate T lymphocytes in blood products. Deglycerolized red blood cells and blood plasma components do not need to be irradiated. Red blood cell components shall be irradiated within 14 days after whole blood collection. The quality control requirements for irradiated blood products shall be the same as those for the original blood products. 3.28 labeled volume The method of indicating the volume of blood products on the labels of blood products is in milliliters, and the labeled volume is determined based on local actual conditions. 3.29 freezing Reducing the core temperature of blood plasma to below -30 °C within 1 hour by rapidly freezing plasma products.4 Blood safety testing requirements4.1 Blood typing 4.1.1 The ABO blood typing test results are correct. 4.1.2 The RhD blood typing test results are correct. 4.2 The human immunodeficiency virus (HIV-1 and HIV-2) marker screening test results are negative. There are two options for specific markers and their detection methods, either of which can be chosen. -- Use ELISA reagents from one manufacturer to detect HIV-1 and HIV-2 antibodies, and use ELISA reagents from another manufacturer to jointly detect HIV-1 and HIV-2 antigens and antibodies; ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB 18469-2012 be delivered?Answer: The full copy PDF of English version of GB 18469-2012 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB 18469-2012_English with my colleagues?Answer: Yes. 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