YY/T 1770.1-2021 English PDFUS$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1770.1-2021: Test method for thrombogenicity study - Part 1: Thrombogenicity study in dogs in vivo Status: Valid
Basic dataStandard ID: YY/T 1770.1-2021 (YY/T1770.1-2021)Description (Translated English): Test method for thrombogenicity study - Part 1: Thrombogenicity study in dogs in vivo Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Word Count Estimation: 10,173 Issuing agency(ies): State Drug Administration YY/T 1770.1-2021: Test method for thrombogenicity study - Part 1: Thrombogenicity study in dogs in vivo---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 thrombogenicity study - Part 1.Thrombogenicity study in dogs in vivo ICS 11.040.01 C30 People's Republic of China Pharmaceutical Industry Standards Medical device thrombosis test Part 1.In vivo thrombosis test in dogs Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration ForewordYY/T 1770 "Medical Device Thrombosis Test" is divided into the following parts. ---Part 1.Thrombosis test in dogs; ---Part 2.In vitro thrombosis test; ... This part is part 1 of YY/T 1770. This section was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the 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 the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Shenzhen Institute of Drug Inspection (Shenzhen Medical Device Inspection Inspection Center). The main drafters of this section. Qiao Chunxia, Lin Zhenhua, Cao Ping, Xu Weiqu, Dong Chuanjun, Han Naishui.IntroductionThe evaluation of thrombosis of medical devices can be performed in vivo, semi-in vivo and in vitro tests. Vascular patch, intravascular catheter, etc. and circulation When evaluating the blood compatibility of medical devices in contact with blood, it is necessary to evaluate the thrombosis in the body. YY/T 1770 This part is the specific test method for thrombosis test in dogs, which can be used as GB/T 16886.4 Chinese medical device/material thrombosis test Supplement. Medical device thrombosis test Part 1.In vivo thrombosis test in dogs1 ScopeThis part of YY/T 1770 specifies that dogs should be used for in vivo thrombosis tests when evaluating the blood compatibility of medical devices/materials. Empirical method. This section is suitable for evaluating whether medical devices/materials cause thrombosis in the body.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Test Selection for Interaction with Blood3 Terms and definitionsThe terms and definitions defined in GB/T 16886.1 and GB/T 16886.4 apply to this document.4 Test principleWhen medical devices/materials come into contact with human blood, the surface of the material may cause plasma proteins (such as albumin and fibrinogen, etc.) to adhere and adhere. The protein layer will activate the coagulation pathway and cause the adhesion of platelets, forming fibrin and platelet thrombus, respectively, and the two will promote each other. Finally, a thrombus is formed. Therefore, the medical device/material is implanted in the body through appropriate procedures, and after a certain period of time, observe the device/material table The thrombosis of the surface, implantation site, and distal organs can comprehensively reflect the adhesion of medical devices/materials to proteins in the blood, and activate the blood clotting system. The path and the conditions that cause platelet adhesion, so as to determine whether the medical device/material has the effect of inducing thrombosis or anti-thrombosis.5 Experimental animalsThe animal species selected in this experiment is dog, and Beagle is the preferred strain, and there is no restriction on male and female (if female animals are used, they should be non-pregnant). Push At least 2 experimental animals are recommended. It is advisable to select suitable experimental animals according to the size of the test samples. The general principle is to choose larger animals as much as possible. In order to reduce the test error caused by the mismatch between the animal blood vessel and the test sample. All animal testing should be in line with the welfare of laboratory animals Tests are conducted in regulated laboratories. Note. For intravascular implantation, it is recommended that the cross-sectional area of the implant occupies less than 50% of the vascular cavity. According to the sample size, animal anatomy characteristics, select other bodies The suitability of larger animals is explained.6 Main instruments and test equipment6.1 Electronic balance. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1770.1-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1770.1-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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