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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1477.5-2020: Standard test models for primary wound dressing performance evaluation - Part 5: Invitro model for hemostatic performance evaluation Status: Valid
Basic dataStandard ID: YY/T 1477.5-2020 (YY/T1477.5-2020)Description (Translated English): Standard test models for primary wound dressing performance evaluation - Part 5: Invitro model for hemostatic performance evaluation Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Classification of International Standard: 11.120.20 Word Count Estimation: 10,141 Date of Issue: 2020 Date of Implementation: 2021-04-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies an in vitro model for evaluating the hemostatic properties of contact wound dressings. This standard applies to the evaluation of the hemostatic properties of sheet-like contact wound dressings that claim to have hemostatic properties. YY/T 1477.5-2020: Standard test models for primary wound dressing performance evaluation - Part 5: Invitro model for hemostatic performance evaluation---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. Standard test models for primary wound dressing performance evaluation--Part 5.Invitro model for hemostatic performance evaluation ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Standard test model for performance evaluation of contact wound dressing Part 5.In vitro model for evaluating hemostatic performance 2020-03-31 released Implementation on 2021-04-01 Issued by the State Drug Administration ForewordYY/T 1477 "Standard Test Model for Performance Evaluation of Contact Wound Dressings" consists of the following parts. ---Part 1.In vitro wound model for evaluating antibacterial activity; ---Part 2.Evaluation of animal scald models for promoting wound healing performance; ---Part 3.In vitro model for evaluating fluid control performance; ---Part 4.In vitro model for evaluating the potential adhesion of wound dressings; ---Part 5.In vitro model for evaluating hemostatic performance; ---Part 6.Evaluation of animal type 2 diabetes refractory wound model for promoting wound healing performance; --- This part is part 5 of YY/T 1477. This section was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain 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 Shandong Medical Device Product Quality Inspection Center. Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Sykes Biotechnology Co., Ltd., Johnson & Johnson (Part 1) Sea) Medical Equipment Co., Ltd. The main drafters of this section. Qiao Chunxia, Gao Ranran, Zhao Zenglin, Zhang Chunxia, Zhang Linlin, Wan Xiang.IntroductionTraditionally, animal models are used to evaluate the hemostatic properties of materials. Animal models have the following limitations. ---Choose the difference between animals and humans; ---Consumption of laboratory animals is not conducive to animal protection; ---The experimental design is relatively complicated; ---Experimental cost is high. The in vitro model given in this section is a test that uses human blood to simulate the bleeding type of bleeding to the greatest extent. A model for testing on a specially developed testing instrument. This model can be used as a supplementary evaluation model for evaluating the hemostatic properties of materials. Like all evaluation models of wound dressings, the test models given in this section have their limitations, which are different from the evaluation results of in vivo models. The relevance has yet to be confirmed. Standard test model for performance evaluation of contact wound dressing Part 5.In vitro model for evaluating hemostatic performance1 ScopeThis part of YY/T 1477 specifies an in vitro model for evaluating the hemostatic properties of contact wound dressings. This section is suitable for evaluating the hemostatic properties of sheet contact wound dressings that claim to have hemostatic properties. Note 1.This section recommends the use of human blood, such as the use of animal blood must be confirmed. Note 2.In view of the different shapes and hemostatic mechanisms of hemostatic dressings in the body, as well as the complexity of the use in the body, this model can be used for screening after confirmation Evaluation. Note 3.After verification of other contact wound hemostatic dressings that are not in accordance with medical device management, this standard can also be referred to.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 Hemostatic performance Various hemostatic mechanisms in materials or materials, such as promoting platelet aggregation and activating the coagulation cascade pathway, promote blood coagulation and shorten coagulation Time to achieve hemostatic effect, thereby reducing blood loss.3 Model compositionThe test device for constructing an in vitro model of hemostatic performance mainly consists of an analytical balance (precision 0.0001g), a sample holding device, a negative pressure system, The data acquisition, processing and output system and connecting pipelines are composed, as shown in Figure 1.4 blood preparation4.1 The blood used for the test is collected from healthy adult blood donors, excluding patients who are known to have used blood clotting drugs. Each donor donates 30mL of blood is collected with a blood collection tube containing heparin sodium or heparin lithium. Then divide the blood into 30 small centrifuge tubes, 1 mL each And store at room temperature. In this way, the blood collected from each donor can be used for 30 tests. After blood collection, all tests should be completed within 2 hours. Long-term use does not exceed 4h. 4.2 Recombinant tissue factor (rTF) with a final concentration of 5pmol/L is added to each milliliter of blood to simulate human wounds. Note. The principle is that no active TF (tissue factor) is detected in the blood of healthy donors, and in the case of wounds, extravascular TF is in contact with blood. Combined with the seventh coagulation factor (plasma factor VIIa) activated in plasma to form a complex, it activates the exogenous coagulation cascade pathway. Activation of the coagulation pathway It will promote the aggregation of platelets, thereby speeding up the coagulation process and achieving the purpose of hemostasis.5 Preparation of test samples5.1 For sheet hemostatic materials, use a 5mm diameter cutter to cut the finished hemostatic material to be tested into a 5mm diameter disc If the thickness of the sample after cutting is less than 2mm, the wafers of multiple samples can be stacked to make the total thickness of 2mm. Note. For foam-like materials, the pores have a certain degree of unevenness. If the test sample is too thin, it will increase the discreteness of the test data. 5.2 A blank control test without hemostatic material should be carried out in parallel to eliminate the system error introduced by the test method and evaluate the stability of the test system. Qualitative. Note. If there is no hemostatic dressing with the same base material, a non-hemostatic dressing with the same base material can be used as a control group.6 Model test procedure6.1 Screening of test needles Install the sample holding device as shown in Figure 1, but the injection needle is not inserted into the blood, turn on the negative pressure suction system to make the sample holding device receive -4kPa pressure, observe and use a stopwatch to record the rate of bubbles in the airflow monitoring bottle. If the bubble rate is significantly lower than that of a smooth needle The speed indicates that there is a blockage in the inner cavity of the test injection needle. Blocked needles cannot be used for evaluation tests. Turn off the negative pressure suction source. Note. This screening process can effectively prevent the impact of blocking for the final test evaluation and improve the repeatability of test data. 6.2 Test procedure 6.2.1 After passing the screening test, adjust the sample holding device downwards so that the needle tip is inserted below the blood level and as close as possible to the bottom of the blood container. Department, but not in contact with it. 6.2.2 Turn on the negative pressure suction system so that the blood flows through the injection needle to the fixed in the syringe under the action of a constant pressure of -4kPa. Test materials. 6.2.3 Observe the rise of the blood level in the injection needle seat and syringe, and start the test recording system at the moment when the blood starts to contact the test material. System, the acquisition system starts to record the data that the quality of the balance decreases with time for 90s, and the acquisition system calculates and displays the initial flow rate Vi (the blood quality reduction in 0s~30s divided by 30s) and the final flow rate Vf (the blood quality reduction in 60s~90s divided by 30s), and calculate and display the flow drop according to formula (1). 6.3 Calculation and evaluation of results Calculate the average value and standard deviation of the test sample group, control sample group, and blank control group, and draw a box plot to compare the difference.7 Model application7.1 The "flow drop (d)" measured by this test model characterizes the hemostatic performance of the material. Under the same test conditions, the flow drop Larger indicates that the material has better hemostatic properties. 7.2 Individual differences in human blood, differences in experimental design and clinical relevance, proficiency of operators, and availability of test devices Due to the influence of factors such as the use of this model, only the flow drop obtained from the test of the material being evaluated is not sufficient to indicate the hemostatic performance of the test material. only In the same evaluation model (including the same test blood and test parameters), the sample to be evaluated and the recognized hemostatic sample on the market are simultaneously entered The test results are comparable. Only by adopting such a lateral comparison evaluation method, can it be concluded that the hemostatic performance between materials is poor Evaluation conclusion of the opposite sex. For users to combine the performance of the evaluated hemostatic material and improve the hemostatic performance of the new material according to the requirements of risk management Scientific evaluation is the main purpose of developing this experimental model. This model is particularly suitable for cross-sections between hemostatic materials with the same or similar hemostatic mechanism. To compare. Note. This model cannot fully simulate the actual use of the product, and its use has certain limitations. The correlation between the in vitro model and the in vivo model has not been tested It is verified that the in vivo model cannot be replaced without sufficient data support. 7.3 The test model can be adjusted and deviated according to specific conditions. However, it is recommended that the deviation be described in the final evaluation report. See Appendix A for an example of an application method suitable for this model. Note. The application of this model requires the use of human blood and sharps that may carry pathogenic microorganisms, and must be trained by trained professionals in the biosafety laboratory Under the conditions, follow the standardized operating procedures, and carry out the harmless disposal of the blood, samples and consumables after the test according to relevant regulations.Appendix A(Informative appendix) Model application examples A.1 Main equipment A.1.1 This test model (injection needle is 0.3mm). A.1.2 Sample punching device. A.1.3 Sample pusher. A.2 Test grouping A.2.1 Test sample group The evaluated hemostatic material [PU (50%PEG)] (denoted as PU hemostatic material B). A.2.2 Control sample group Control group 1-commercially available collagen sponge; Control 2 groups---commercially available gelatin sponge; Control 3 groups---same base material hemostatic dressing [PU(40%PEG)] (denoted as PU hemostatic material A). A.2.3 Blank control group Material-free blood. A.2.4 Sample preparation Process the samples of the test sample group and the materials of each control group into discs with a diameter of 5mm and a thickness of 2mm in the same way, and prepare at least 15 valid test samples, each sample is placed into the bottom of a disposable 1mL syringe with the help of the core rod of the syringe, and each group of samples Numbering. A.3 Blood preparation Before the test, prepare a total of 90mL (30mL each) of whole blood for A, B, and C according to Chapter 4, and label them as "A blood", "B blood" and "C blood". A.4 Test procedure A.4.1 Divide each test group into three groups. "Group A", "Group B" and "Group C". A.4.2 According to the provisions of Chapter 6, the test samples of "Group A", "Group B" and "Group C" are tested with "A blood", "B blood" and "C blood" respectively. For groups A, B and C, at least 5 valid test data are obtained in each group, and at least 15 valid test data are obtained in each test group. A.5 Results presentation A.5.1 Report the average and standard deviation of the flow drop of the blank control group, control sample group and test sample group (see Table A.1). A.6 Evaluation conclusion The hemostatic performance of the test sample group is given an overall conclusion relative to the commercially available products. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1477.5-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1477.5-2020_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 1477.5-2020_English with my colleagues?Answer: Yes. 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