GB 14232.3-2011 English PDFUS$234.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 14232.3-2011: Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features Status: Valid
Basic dataStandard ID: GB 14232.3-2011 (GB14232.3-2011)Description (Translated English): Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features Sector / Industry: National Standard Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 12,114 Date of Issue: 2011-12-30 Date of Implementation: 2012-12-01 Quoted Standard: GB 14232.1-2004 Adopted Standard: ISO 3826-3-2006, IDT Regulation (derived from): Announcement of Newly Approved National Standards No. 22 of 2011 Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This Chinese standard specifies the requirements (including performance requirements) of special component of the non-ventilated bacteria bag plastic container (blood bag system). Blood bag system does not include the section given in all the special components. These special components means: leukocyte filters, blood sampling device before, top end of the bag, platelet storage bag, Anti- needle protection device. In addition to GB 14232. 1 Conventional containers provided for the requirements, GB 14232 this standard also provides for multiple blood bag system associated additional requirements. GB 14232 this standard does not include automated blood collection system. Unless otherwise specified, GB 14232 all tests specified in this standard apply to the state for the use of plastic bags. Where applicable, the required use of GB 14232. 1 chemical, physical and biological tests. GB 14232.3-2011: Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features---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. Plastics collapsible containers for human blood and blood components.Part 3. Blood bag systems with integrated features ICS 11.040.20 C31 National Standards of People's Republic of China Human blood and blood components bag plastic containers Part 3. blood bag system with special components Part 3. Bloodbagsystemswithintegratedfeatures (ISO 3826-3.2006, IDT) Issued on.2011-12-30 2012-12-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released ForewordGB 14232 All technical content in this section is mandatory. GB 14232 "human blood and blood components bag plastic container" consists of the following components. --- Part 1. Conventional blood bags; --- Part 2. Graphical symbols; --- Part 3. blood bag system with special components. This is Part 3 GB 14232's. This section drafted in accordance with GB/T 1.1-2009 given rules. GB 14232 in this part of the translation method identical with ISO 3826-3.2006 "human blood and blood components bag plastic container Part 3. Includes special blood bag system components. " This part is proposed by the State Food and Drug Administration. This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized. This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center, Shanghai Transfusion Technology Co., Ltd. Participated in the drafting of this section. Shandong Weigao Medical Polymer Company Limited. The main drafters of this section. Wu Ping, Jiang Yueqin by Shaohua, Luo Hongyu.IntroductionSuch as when national authorities request plastic bags manufacturers or suppliers would like the competent authorities to submit all plastic materials, materials and components For more information details of production and plastic bags of their production methods, including the name of any chemical additives, the content of these additives are A plastic blood bag manufacturer to join or material contained in, and all the used additives details. Human blood and blood components bag plastic containers Part 3. blood bag system with special components1 ScopeGB 14232 of the provisions of this part of the air-impermeable sterile plastic bag container (blood bag system) requirements including special components (including the performance to begging). Special blood bag system need not include all the components in this section are given. These special components means. --- Leukocyte filter; --- Before blood sampling device; --- Top end of the bag; --- Platelet storage bag; --- Anti-needle protection device. In addition to GB 14232.1 prescribed conventional blood bag requirements, GB 14232 This section also provides for multi-linked blood bag system Additional requirements. GB 14232 of this section does not include automated blood collection system. Unless otherwise specified, all tests GB 14232 provisions of this Part apply to the state for the use of plastic bags. When applicable, the use of GB 14232.1 specified chemical, physical and biological tests.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 14232.1-2004 human blood and blood components bag plastic containers - Part 1. Conventional blood bags (ISO 3826-1. 2003, IDT)3 Terms and DefinitionsGB 14232.1 define the following terms and definitions apply to this document. 3.1 Leukocyte filter leucocytefilter, LCF Blood and blood components for reducing the leukocyte content filter. 3.2 Before blood sampling device pre-donationsamplingdevice, PDS Blood bag system is located in the pipeline, initially designed as part of the mining bleeding (i.e. "First blood") means isolated. Note. The Y-piece will be a pre-donation and blood sampling device connected to the pipeline, so that blood can flow into the pre-donation sampling device, or into the blood bag. 3.3 Top and bottom bags topandbottombag, TBB Top and bottom entrance of the blood bag. Note. The top and bottom part of the bag is a multiple bag system for centrifugation of anticoagulated whole blood. After centrifugation, plasma bags from the top of the separation of packed red blood cells from the blood bag The bottom outlet separation. 3.4 Platelet storage bag plateletstoragebag, PSB Suitable for storage of a therapeutic dose of platelet concentrates (available from one or more donors donors made) blood bag. Note. the platelet storage bag may be a single blood bag, can also be a part of the blood bag system. 3.5 Anti-needle protection device needlestickprotectiondevice, NPD Blood and blood bag system piping are integrated, and contains lancet assembly. It is designed to prevent accidents after using the lancet acupuncture.4 dimensions and marking4.1 Dimensions Figures 1 and 2 shows a blood bag system as specific components of the composition, the total of the components illustrated in Figure and only guide. Size should be consistent 4.1 GB 14232.1-2004 in Figure 1 below. 4.2 tag example Thumbnail plastic container with a special assembly of descriptive words "plastic bags" plus GB 14232 this part number, plus given in Chapter 3 word. For example, in line with GB 14232 labeled plastic bags with leukocyte filter requirements of this section are. Plastic bags GB 14232.3-LCF 1 --- pre-donation sampling means (PDS); The first 2 --- donate blood sampling bags; 3 --- multiple sampling device; 4 --- lancet; 5 --- Anti-needle protection device (NPD); 6 --- blood bag system; 7 --- top end of the bag (TBB); 8 --- top outlet; . 9 --- outlet at the bottom; 10 --- blood collection; . 11 --- transfer bags; 12 --- empty transfer bags; 13 --- platelet storage bag (the PSB); --- Transfer for 14 empty bags; 15 --- with added liquid transfer bags; 16 --- leukocyte filter (LCF). a plugging means may be in other parts. b This configuration of the top end of the bag and the blood bags containing anticoagulant. c this configuration to white fine filter is a filter erythrocyte concentrates. Figure 1 type of red blood cells with leukocyte filter platelet storage bags, blood sampling devices before and Top end of the bag blood bag system and other special components that comprise the schematic 1 --- pre-donation sampling means (PDS); The first 2 --- donate blood sampling bags; 3 --- multiple sampling device; 4 --- lancet; 5 --- Anti-needle protection device (NPD); 6 --- blood bag system; 7 --- blood bags; 8 --- top outlet; . 9 --- blood collection; 10 --- transfer bags; . 11 --- empty transfer bags; 12 --- with added liquid transfer bags; 13 --- leukocyte filter (LCF). a plugging device. It may be in other parts. b This configuration blood bags containing anticoagulant. c The LCF configuration for filtration of whole blood. 2 blood bag system with full blood leukocyte filter special components and pre-donation sampling device consisting of a schematic diagram, etc.5 Design5.1 to leukocyte filter 5.1.1 plastic bags in the leukocyte filter for whole blood or blood component filtration. It is designed to reduce whole blood or blood components in White blood cells, the filter can be designed at 4 ℃ or gravity filtration at ambient temperature and pressure filter according to the technical specification requirements. Leukocyte filter can also be installed on other transfusion equipment. Leukocyte filter may need to meet national standards 1). 1) See YY0329-2002. 5.1.2 The manufacturer shall recommend to filter out white blood cells intended use, the relevant parameters include. --- Blood collection and filtration of leukocytes delay time between; --- Filtering capabilities; --- Blood filtration temperature; --- Filter height; --- Working pressure; --- Centrifugal suitability. 5.2 pre-donation sampling means 5.2.1 pre-donation sampling device should be able to state a sterile blood sample collected in vacuum blood collection tube. 5.2.2 If the first blood sampling device comprising a blood collection bags having a capacity of at least 35mL. 5.2.3 pre-donation sampling devices shall be designed so that when you press the test of GB 14232.1-2004 Section B.2, which charged an average flow rate of at least 50mL/min. 5.2.4 blood sampling device shall be taken before and after harvest to prevent bleeding into the sample and (or) air from the sampling point to the blood donors and blood bags backflow device. The apparatus may be integral may be separated. For specific blood collection, blood donation may be required before sampling without anticoagulant and to avoid hemolysis. 5.2.5 The manufacturer shall give advice pre-donation sampling means optimal use. 5.3 bottom bags 5.3.1 ships with a top end of the bag for use with automatic pressurization system, can by means of a device such as an optical sensor or the like, between the upper lower Leukocyte and platelet rich layer components (buffy coat) remain in the blood bag. 5.3.2 If the top outlet and bottom outlet of different caliber, the manufacturer should be required to give its customers should be able size. 5.4 platelet storage bag 5.4.1 platelet storage bag should have good ventilation, so that the oxygen and carbon dioxide through, and should be stored under controlled temperature conditions Platelet concentrates number of days (in the oscillation storage conditions). 5.4.2 Effect of platelet storage is also affected by platelet count, platelet concentrates the volume of container specifications and oscillations and other factors, usually through Observing vortex (swirling), measuring pH, hypotonic shock reaction and the reaction is evaluated clustering. 5.5 Anti-needle protection device The manufacturer shall give advice needle protection device preventing the best use. Anti-needle protection devices may be required by the national standard. 5.6 air content When calculated according to GB 14232.1-2004 air content, if the design or operation of the system does not make the filter assembly or before blood sampling Contained in the air bag of blood components into the final air volume calculation does not have to include these components in the air. For other vessels, such as the top end of the bag, platelet storage bags, when they last used the system storage containers, air volume limit requirement Still apply.6 RequirementsTable 1 provides requirements GB GB 14232 corresponding to this part of the distinctive components 14232.1-2004 given in Chapter 6 a Lanbiao. Table 1 GB 14232.1-2004 applicability of the requirements of Chapter 6, the blood bag system with a special assembly of Claim (GB 14232.1-2004 bars and phrases) Leukocyte filter Pre-donation Sampling means The top end of the bag Blood platelet Storage bag Anti-acupuncture Paul Protection device 6.1 General applicable applicable applicable applicable applicable a Physical Requirements 6.2 plastic bags and each special assembly 6.2.1 Production Conditions Applicable Applicable Applicable Applicable Applicable 6.2.2 Sterilization 6.2.2.1 sterilization method is applicable applicable applicable applicable applicable 6.2.2.2 Sterilization adverse effects Applicable Applicable Applicable Applicable Applicable 6.2.2.3 sterilization effectiveness Applicable Applicable Applicable Applicable Not Applicable 6.2.3 Transparency applicable Not applicable Not applicable applicable applicable 6.2.4 Color Not applicable applicable applicable applicable not applicable 6.2.5 Thermal stability Not applicable Not applicable Not applicable applicable applicable 6.2.6 steam revealing applicable Not applicable Not applicable Not applicable Not applicable b 6.2.7 c anti-leak applicable applicable applicable applicable not applicable d 6.2.8 particulate pollution applicable applicable applicable applicable not applicable 6.3 Chemical requirements 6.3.1 original container or sheet requirements applicable Not applicable Not applicable applicable applicable e 6.3.2 Test fluid requirement does not apply f e applicable applicable applicable not applicable 6.4 Requirements Biology 6.4.1 General Applicable Applicable Applicable Applicable Not Applicable 6.4.2 g microbial impermeability applicable Not applicable applicable applicable applicable h 6.4.3 Compatibility Applicable Applicable Applicable Applicable Not Applicable a leukocyte filter is not necessarily soft. b in a given storage period of time, the permeability of the material is conducive to maintaining the vitality of platelets, platelet storage bag see special requirements. c depending on the type of leukocyte filter, the filter should be able to withstand the maximum pressure under normal operating conditions (ie, the maximum hydrostatic head pressure of gravity or plasma transfusions when force). D before blood sampling bags should be able to withstand the pressure test, the test except centrifugation and 4 ℃. e applies only to the container. f filter should satisfy the biochemical requirements for plastic pharmacopoeia given. g leukocyte filter housing must be impervious to microorganisms. The filter is not expected to remove blood and blood components in microorganisms. h applies only sampling bags. Transfer blood bag for blood collection tube before blood sampling point should be permanently sealed.7 PackagingTable 2 provides a list of requirements GB 14232.1-2004 Chapter 7 GB 14232 corresponding to each particular component of this part is given. Table 2 GB 14232.1-2004 requirements of Chapter 7 of the applicability of the special components of the blood bag system Claim (GB 14232.1-2004 bars and phrases) Leukocyte filter Pre-donation Sampling means The top end of the bag Blood platelet Storage bag Anti-acupuncture Paul Protection device 7.1 Scope Applicable Applicable Applicable Applicable 7.2 storage life Applicable Applicable Applicable Applicable Applicable 7.3 packaging material suitable for a applicable applicable applicable applicable a a 7.4 outer seal Applicable Applicable Applicable Applicable Applicable 7.5 packaging intensity applicable applicable applicable applicable applicable 7.6 packaging in place applicable applicable applicable applicable applicable these components do not need a special offer specialized packaging.8 LabelTable 3 provides all the requirements of GB 14232 GB corresponds to this part of the distinctive components 14232.1-2004 Chapter 8 gives a Lanbiao. Table 3 GB 14232.1-2004 Chapter 8 of the applicability of the requirements of special components of the blood bag system Claim (GB 14232.1-2004 bars and phrases) Leukocyte filter Pre-donation Sampling means The top end of the bag Blood platelet Storage bag Anti-acupuncture Paul Protection device 8.1 General applicable applicable applicable applicable applicable 8.2 Each labeling requirements for plastic bags and special components 8.2a) and was built using the Optional Optional Applicable Applicable Not Applicable 8.2b) anticoagulant/preservative solution and recipe collection volume applicable Not applicable Not applicable Not applicable applicable 8.2c) sterile, non-pyrogenic Description Not applicable Not applicable Not applicable applicable applicable 8.2d) metamorphic Description Not applicable Not applicable Not applicable applicable applicable 8.2e) without ventilation Description Not applicable Not applicable Not applicable applicable applicable 8.2f) Disposable Description Not applicable Not applicable Not applicable applicable applicable 8.2g) Description Not applicable Not applicable Not applicable applicable applicable 8.2h) manufacturer/supplier Not applicable Not applicable Not applicable applicable applicable 8.2i) batch identification optional applicable Not applicable Not applicable applicable 8.3 blood bag system packaging label 8.3a) manufacturer/supplier apply 8.3b) contents a description of applicable applicable applicable applicable applicable a a 8.3c) the expiry date applicable 8.3d) after removal from the packaging instructions apply to the expiration date 8.3e) Lot applicable Table 3 (Continued) Claim (GB 14232.1-2004 bars and phrases) Leukocyte filter Pre-donation Sampling means The top end of the bag Blood platelet Storage bag Anti-acupuncture Paul Protection device 8.4 label on the blood bag system shipping box 8.4a) manufacturer/supplier apply 8.4b) contents instructions apply 8.4c) Storage conditions apply 8.4d) batch identification applicable 8.4e) Expiration date applies 8.4f) After removing the packaging from the expiry of the applicable instructions 8.5 Each labeling requirements for plastic bags and special components 8.5a) area of the factory and use information Optional Optional Applicable Applicable Not Applicable 8.5b) was built to facilitate the vision test applicable applicable applicable applicable not applicable 8.5c) to ensure that printing is not seep applicable applicable applicable applicable not applicable 8.5d) printing when using the label remains clearly applicable applicable applicable applicable not applicable Suitability applicable applicable applicable applicable 8.5e) label pasted NA 8.5f) tore signs Applicable Applicable Applicable Applicable Not Applicable 8.5g) should test by GB 14232.1 Chapter B.3 chapter applicable Not applicable Not applicable Not applicable applicable b which should include a description of the special assembly. Permanent labels need not include a test -30 ℃ frozen. 9 anticoagulants and (or) maintenance solution If fitted anticoagulants and (or) maintenance solution, its quality should be consistent with the national pharmacopoeia or national regulations. 3-6283OSI / 1102- 3.23241 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 14232.3-2011_English be delivered?Answer: Upon your order, we will start to translate GB 14232.3-2011_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 GB 14232.3-2011_English with my colleagues?Answer: Yes. The purchased PDF of GB 14232.3-2011_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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