YY/T 1649.2-2019 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 1649.2-2019: Test method for interactions of medical devices with platelet -- Part 2: In vitro platelet activation products(β-TG, PF4 and TxB2)assay Status: Valid
Basic dataStandard ID: YY/T 1649.2-2019 (YY/T1649.2-2019)Description (Translated English): Test method for interactions of medical devices with platelet -- Part 2: In vitro platelet activation products(��-TG, PF4 and TxB2)assay Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.040.01 Word Count Estimation: 8,886 Date of Issue: 2019 Date of Implementation: 2020-10-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies the in vitro platelet activation test method for the interaction of medical devices/materials with platelets when evaluating the blood compatibility of medical devices/materials in vitro. This standard applies to the evaluation of platelet adhesion properties and activation potential on the surface of medical devices/materials. The test system established in this standard is applicable to human blood. If animal blood is used, tests can be performed on the basis of justifying its suitability. YY/T 1649.2-2019: Test method for interactions of medical devices with platelet -- Part 2: In vitro platelet activation products(β-TG, PF4 and TxB2)assay---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. Test method for interactions of medical devices with platelet-Part 2. In vitro platelet activation products (β-TG, PF4 and TxB2) assay ICS 11.040.01 C30 People's Republic of China Pharmaceutical Industry Standard Platelet interaction test Part 2. Platelet activation products in vitro (β-TG, PF4 and TxB2) Published on October 23,.2019 2020-10-01 implementation Published by the State Drug Administration ForewordYY/T 1649 `` Medical Device and Platelet Interaction Test '', including the following. --- Part 1. In vitro platelet counting method; --- Part 2. Determination of platelet activation products (β-TG, PF4 and TxB2) in vitro. This part is the second part of YY/T 1649. This section is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents. This section is proposed by the State Drug Administration. This section is under the jurisdiction of the National Technical Committee for the Standardization of Biological Evaluation of Medical Devices (SAC/TC248). This section was drafted by. Shandong Provincial Medical Device Product Quality Inspection Center, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection Test center). The main drafters of this section. Qiao Chunxia, Wang Guowei, Yuan Kun, Liang Jie, Zheng Liping.IntroductionThere are many methods for evaluating platelets and their activation status, but the most commonly used method for evaluating medical devices and materials in contact with blood It is a simple platelet counting method and a method of releasing platelet particulate matter. This part of YY/T 1649 is in vitro platelet activation test Specific test methods can be used as a supplement to the evaluation of the interaction between medical devices/materials and platelets in GB/T 16886.4. As an important component of blood, platelets play a key role in preventing bleeding. Platelet particulate matter in blood after contact with device/material The increase indicates that platelets are activated, which will directly affect the blood compatibility of medical devices/materials. Described in this part of YY/T 1649 The in vitro assay of platelet activation products can be used to evaluate the potential adhesion and activation of platelets by medical devices/materials. Platelet interaction test Part 2. Platelet activation products in vitro (β-TG, PF4 and TxB2)1 ScopeThis part of YY/T 1649 specifies that when performing blood compatibility evaluation of medical devices/materials in vitro, medical devices/materials and blood Platelet Interaction in vitro Platelet Activation Test Method. This standard applies to the adhesion and activation of platelets on the surface of medical devices/materials. Evaluation of potential. The test system established in this section applies to human blood. If animal blood is used, it can be tested on the basis of demonstrating its suitability.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 16886.1 Biological evaluation of medical devices. Part 1. Evaluation and testing during risk management GB/T 16886.4 Biological evaluation of medical devices. Part 4. Selection of tests for interaction with blood GB/T 16886.12 Biological evaluation of medical devices. Part 12. Sample preparation and reference materials3 terms and definitionsThe terms and definitions defined in GB/T 16886.1, GB/T 16886.4, and GB/T 16886.12 apply to this document.4 OverviewWhen medical devices/materials come in contact with human blood, the increase in particulate matter in the blood may be caused by medical devices/materials or promote bleeding or Causes of Thrombosis. A significant increase in platelet particulate matter compared to controls indicates that the medical device/material has the potential to activate platelets can. Common platelet particulate matter mainly includes β-thromboglobulin (β-TG), platelet factor 4 (PF4), and thromboxane B2 (TxB2) and so on. 5 Test principle (taking β-TG as an example) The ELISA kit used the double antibody sandwich method to determine the human β-TG level in the specimen. Microtiter plates were coated with purified β-TG antibody to prepare To form a solid phase antibody, β-TG is sequentially added to the microwells coated with the monoclonal antibody, and then combined with horseradish peroxidase (HRP) labeled β-TG antibody. The antibody-antigen-enzyme-labeled antibody complex was formed, and after washing thoroughly, the substrate was added with tetramethylbenzidine (TMB) to develop color. TMB in HRP enzyme It is converted into blue under the catalysis of acid, and finally into yellow under the action of acid. The shade of color is positively correlated with β-TG in the sample. The absorbance (OD value) was measured with a microplate reader at a wavelength of 450 nm, and the human β-TG concentration in the sample was calculated by a standard curve. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1649.2-2019_English be delivered?Answer: Upon your order, we will start to translate YY/T 1649.2-2019_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 1649.2-2019_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1649.2-2019_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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