YY 1741-2021 English PDFUS$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 1741-2021: Antithrombin III testing kit Status: Obsolete YY 1741: Historical versions
Basic dataStandard ID: YY 1741-2021 (YY1741-2021)Description (Translated English): Antithrombin III testing kit Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C44 Word Count Estimation: 7,792 Issuing agency(ies): State Drug Administration YY 1741-2021: Antithrombin III testing kit---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.Antithrombin Ⅲ testing kit ICS 11.040 C44 People's Republic of China Pharmaceutical Industry Standards Antithrombin Ⅲ determination kit Released on 2021-03-09 2023-04-01 implementation Issued by the National Medical Products Administration ForewordThis standard 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. Publication of this document The agency is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee. Drafting organizations of this standard. Chinese People's Liberation Army General Hospital, Beijing SECCO Technology Co., Ltd., Beijing Medical Device Inspection Institute, Shanghai Changdao Biotechnology Co., Ltd., Sysmex Medical Electronics (Shanghai) Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Mai Ke Biological Co., Ltd. The main drafters of this standard. Li Jian, Ding Chonghui, Xu Yong, Xu Han, Lei Ting, Zhang Shuang, Tian Wei, Chen Qiyun.IntroductionIn 1954, Seegers et al. first divided antithrombin into four types. Since then, the name antithrombin Ⅲ has been used. International Health Organization (WHO) established the first-generation international reference product (72/1) in 1978, using the name antithrombin Ⅲ. Made by British National Biology The second-generation international reference product (93/578) prepared by the National Institute for Quality Control (NIBSC) and established by the WHO in.1994, and the third-generation national reference product in.2010 The international reference (08/258) no longer uses the name "antithrombin Ⅲ", but uses the name "antithrombin". Currently, International Thrombosis and Hemostasis The term for the meeting (ISTH) is also antithrombin. The names of products that have been listed on the domestic market are divided into two categories. antithrombin Ⅲ determination kit and Antithrombin determination kit. Although the terminology and international reference products have been unified internationally, in view of the fact that the names of international products According to the actual registration situation of domestic products, antithrombin III is still used in the name of this standard. The international unit of plasma antithrombin is established through a multi-center joint study based on the assignment of normal mixed plasma from each laboratory of. The pooled normal plasma of each laboratory is defined as 1IU, and the public mean is assigned to the standard. Currently, many coagulation diagnostic products are manufactured Manufacturers use the “%” value in their calibration plasma, where 100% is equivalent to 1IU, and use the value of “%” in their calibration plasma and/or diagnostic kits. It is marked in the relevant documents. Therefore, the use of "%" in plasma calibration or quality control is completely acceptable. Antithrombin Ⅲ determination kit1 ScopeThis standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of antithrombin Ⅲ assay kits. This standard is applicable to the kit for the determination of antithrombin III based on the chromogenic substrate method of heparin cofactor activity (hereinafter referred to as the kit). It is suitable for kits for measuring the mass concentration of antithrombin Ⅲ such as turbidimetric method.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version is applicable to this file. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use3 requirements3.1 Appearance The appearance should meet the following requirements. a) The components of the kit should be complete and complete, without leakage, and the label should be clear and easy to identify; b) The liquid reagent should be a homogeneous solution; c) The lyophilized product will be a homogeneous solution after reconstitution. 3.2 Quantity The amount of liquid reagents should not be less than the labeled value. 3.3 Linearity The linearity of the kit covers at least 20%~140%. In the linear interval, the slope of the linear regression equation is in the range of 1±0.05, and the correlation The coefficient r≥0.980. 3.4 Repeatability The repeatability test uses samples with high, medium and low concentration levels. The coefficient of variation (CV) for high-concentration samples should be ≤10%, and medium-concentration samples The coefficient of variation (CV) should be ≤10%, and the coefficient of variation (CV) of low-concentration samples should be ≤15%. 3.5 Accuracy Select one of the following substances to repeat the test 3 times, and calculate the relative deviations respectively, which should not exceed ±15.0%. a) Use recognized reference materials or certified reference materials (CRM); b) Use corporate reference materials traceable to recognized reference materials or certified reference materials. 3.6 Detection limit The detection limit should not be greater than 20%. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 1741-2021_English be delivered?Answer: Upon your order, we will start to translate YY 1741-2021_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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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY 1741-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 1741-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
