GB/T 19335-2022 PDF EnglishUS$230.00 · In stock · Download in 9 seconds
GB/T 19335-2022: Blood flow products for single use - General specification 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/T 19335: Historical versions
Similar standardsGB/T 19335-2022: Blood flow products for single use - General specification---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/GBT19335-2022NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 CCS C 31 Replacing GB 19335-2003 Blood flow products for single use - General specification Issued on. APRIL 15, 2022 Implemented on. MAY 01, 2023 Issued by. State Administration for Market Regulation; Standardization Administration of the People's Republic of China. Table of ContentsForeword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 6 4 General requirements... 6 5 Materials... 6 6 Design... 6 7 Requirements... 8 8 Packaging, marks... 11 Annex A (informative) Design and evaluation requirements... 12 Annex B (normative) Test methods for pressure monitoring joints/sensor protectors 14 Annex C (informative) Example for preparation of chemical performance test solution ... 17 Annex D (informative) Standard implementation guide... 18 Bibliography... 191 ScopeThis Standard specifies the general technical conditions for blood flow products for single use. This Standard applies to the blood flow products for single use and the auxiliary pipelines connected to them, including the products composed of liquid flow and pressure monitoring pipeline (hereinafter referred to as "blood flow").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 8369 (all parts), Transfusion sets for single use GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1.Chemical analysis methods GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for medical use - Part 2.Biological test methods GB/T 16886.1, Biological evaluation of medical devices - Part 1.Evaluation and testing within a risk management process GB/T 19633.1, Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems YY/T 0316, Medical devices - Application of risk management to medical devices YY 0581.1, Infusion access adapters - Part 1.Needle access adapters (Heparin plugs)3 Terms and definitionsThere are no terms and definitions that need to be defined in this document.4 General requirementsIt shall use the established risk assessment procedures to design the blood flow products. When transporting, storing, installing, using and maintaining blood flow products in accordance with the manufacturer's instructions, under normal and single failure conditions, use risk management procedures in accordance with YY/T 0316.Blood flow products shall not present risks that are not reduced to acceptable levels and are associated with their intended use.5 MaterialsThe pipelines directly or indirectly in contact with blood shall be made of materials that meet relevant standards. Leachables from the blood flow due to chemical or physical effects of anticoagulants and/or maintenance fluids, blood and blood components shall be within specified limits.6 Design6.1 Protective cover Each inlet and outlet of the blood flow (except for the inlet and outlet of the pressure monitoring connector/sensor protector) shall have a protective cover. The protective cover shall be secure and easy to remove. 6.2 Injectors 6.2.1 Needleless injectors The needle-free injectors on the blood flow shall meet the relevant requirements of YY 0581.2. 6.3 Connectors 6.3.1 Luer connectors Luer connectors shall comply with the requirements of ISO 80369-7. 6.3.2 Reservoir connectors Connectors connected to citrate anticoagulants shall meet the requirements of ISO 18250-8.2018. 6.4 Blood and blood component filters If there is a blood and blood component filter in the transfusion direction of the blood flow product, it shall be designed to allow filtering only in the direction of the transfusion. 6.5 Switches The flow regulator in the blood flow shall comply with the relevant requirements of GB 8369 (all parts). 6.6 Pressure monitoring joint/sensor protector 6.6.1 Appearance The machine end of the pressure monitoring joint/sensor protector shall be transparent. Blood contamination can be checked visually during use. 6.6.3 Pressure transfer performance The pressure monitoring joint/sensor protector shall have adequate pressure transmission performance. 6.6.4 Blood blocking The filter material in the pressure monitoring joint/sensor protector can effectively block the liquid. When tested according to B.3, under the hydraulic pressure of 40kPa for 40s, there shall be no evidence of liquid penetration.7 Requirements7.1 General Blood flows are designed to maintain high quality blood or blood components. The blood flow is sterile and pyrogen-free under the expected conditions of use. 7.2 Physical properties 7.2.1 Appearance The hose on the blood flow shall be plasticized evenly without kinks. Its transparency shall allow detection of air bubbles in the bloodstream with normal or corrected vision. 7.2.3 Connection firmness Each connection of the blood flow (excluding the protective sleeve) shall be able to withstand a static axial tension of 15N. It shall last 15s without breaking and falling off. 7.2.4 Particulate pollution Blood flows shall be produced with minimal particulate contamination. Liquid passage surfaces shall be smooth and clean. When tested according to the method specified in YY/T 1556, the pollution index shall not exceed 90. 7.2.5 Color code When the blood flow is divided into arterial blood flow and venous blood flow, there shall be a clear color mark within 100mm of the end of the pipeline. The arterial blood flow shall be red. The venous blood flow shall be blue. 7.3 Chemical properties 7.3.1 Guide for test solution preparation The preparation conditions of the chemical performance test solution shall represent the most severe conditions for the clinical use of the product. Design the reasonable and feasible extraction ratio, extraction temperature and extraction time. Prepare the blank control solution in the same way. 7.3.2 Color When observing the test solution with normal vision or corrected vision, the test solution shall be colorless and transparent. 7.3.3 Reducing substances When testing according to 5.2.2 of GB/T 14233.1-2008, the difference between the volume of potassium permanganate solution [c(KMnO4)=0.002mol/L] consumed by 20mL of test solution and blank solution shall not exceed 2.0mL. 7.3.5 pH When testing according to 5.4.1 in GB/T 14233.1-2008, the test solution is compared with the blank solution of the same batch. The difference in pH value shall not exceed 1.5. 7.5 Biological properties 7.5.1 General requirements Blood flow products shall be biologically evaluated according to GB/T 16886.1. 7.5.2 Sterile Blood flow products shall be supplied sterile and shall meet the requirements of YY/T 0615.1. 7.5.3 Bacterial endotoxin Blood flow products shall control bacterial endotoxin content in corresponding product standards. Carry out the test according to the test method given in GB/T 14233.2.It shall not exceed 20EU/set.8 Packaging, marksThe manufacturer of the blood flow shall provide evidence that its single package complies with GB/T 19633.1. ......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/T 19335-2022 be delivered?Answer: The full copy PDF of English version of GB/T 19335-2022 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/T 19335-2022_English with my colleagues?Answer: Yes. 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