YY/T 1253-2015 English PDFUS$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1253-2015: Low density lipoprotein (LDL) cholesterol assay kit Status: Valid
Basic dataStandard ID: YY/T 1253-2015 (YY/T1253-2015)Description (Translated English): Low density lipoprotein (LDL) cholesterol assay kit Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 9,955 Date of Issue: 2015-03-02 Date of Implementation: 2016-01-01 Quoted Standard: YY/T 0466.1 Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8 Issuing agency(ies): State Food and Drug Administration Summary: This Standard specifies the low-density lipoprotein cholesterol assay reagent (kit) requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This Standard applies to the use of the direct method in human serum or plasma low-density lipoprotein cholesterol quantitative detection reagent (kit), based on the principle of spectrophotometry, including manual reagents and on the semi-automatic biochemical analyzer used. YY/T 1253-2015: Low density lipoprotein (LDL) cholesterol assay 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.Low density lipoprotein (LDL) cholesterol assay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards LDL cholesterol assay reagent (kit) Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Medical Device Testing, Beijing Leadman Biochemistry Co., Ltd., Hitachi High-Technologies (Shanghai) State International Trade Co., Ltd. Beijing Branch, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Pharmaceutical Co., Ltd. Rongsheng Sheng matter. The main drafters of this standard. Bi Chunlei, Wang Lanzhen, Cheng Qing, Wang Jun, Tang Wei, Zhang Zhengjiang. LDL cholesterol assay reagent (kit)1 ScopeThis standard specifies the low-density lipoprotein cholesterol assay reagent (kit) requirements, test methods, marking, labeling and instructions for use, package Loading, transportation and storage. This standard applies to the use of the direct method in human serum or plasma low-density lipoprotein cholesterol quantitative detection reagent (box), the base Spectrophotometry in principle, including manual reagents and on the semi-automatic biochemical analyzer used.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Requirements3.1 Appearance 3.1.1 Kit components should be complete, complete, no liquid leakage. 3.1.2 Packaging label text symbols should be clear. 3.2 PACKING Not less than the indicated value. 3.3 reagent blank absorbance When adding reagent blank sample test, the absorbance of the reagent blank should be < 0.05. 3.4 Sensitivity Analysis Determination of 1.00mmol/L samples, the absorbance difference (ΔA) should be > 0.03. 3.5 Linear Reagent (box) within the linear [0.30,10.00] mmol/L range. a) The linear correlation coefficient (r) shall be not less than 0.995; b) within [0.30,10.00] mmol/L range, linearity deviation should not exceed ± 0.30mmol/L or no more than ± 10%. 3.6 Precision 3.6.1 Repeatability Repeat the test (2.50 ± 0.50) mmol/L and (5.00 ± 1.00) mmol/L in the sample, the results of the coefficient of variation (CV) should not 3%. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1253-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 1253-2015_English as soon as possible, and keep you informed of the progress. 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