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YY/T 1205-2013 PDF EnglishSearch result: YY/T 1205-2013
YY/T1205-2013 (YYT1205-2013): PDF in EnglishYY/T 1205-2013 YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA YYY/T 1205-2013 Total bilirubin test kit (Vanadate oxidation method) Issued by. State Food and Drug Administration ISSUED ON. OCTOBER 21, 2013 IMPLEMENTED ON. OCTOBER 1, 2014 Table of Contents Foreword ... 3 1 Scope ... 4 2 Normative References ... 4 3 Requirements ... 4 4 Test Method ... 5 5 Mark, Label and Instructions ... 7 6 Packaging, Transport and Storage ... 8 Foreword This Standard was drafted in accordance with the rules specified in GB/T 1.1-2009. Please note that some contents in this Document may involve patents. The issuing organization of this Document does not undertake the responsibility to identify these patents. This Standard was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136). Drafting organization of this Standard. National Institute for Food and Drug Control. The main drafters of this Standard. Wang Yumei, Liu Yan, Wang Yumei, Gao Shangxian, and Zhang Chuntao. Total bilirubin test kit (Vanadate oxidation method) 1 Scope This standard specifies the determination principle, requirements, test method, signs, instructions, packaging, transport and storage of total bilirubin test kit (Vanadate oxidation method). This standard applies to the quality control of total bilirubin test kit (Vanadate oxidation method). 2 Normative References The following document is indispensable for the application of this document. For dated references, only dated edition applies to this document. For undated references, the latest edition (including all amendments) applies to this document. YY/T 0466.1 Medical Devices. Symbols to Be Used with Medical Device Labels, Labeling and Information to Be Supplied. Part 1. General Requirements 3 Requirements 3.1 Appearance It shall meet the appearance requirements specified the manufacturer. 3.2 Installed capacity The installed capacity of liquid reagent shall not be less than the labeled amount. 3.3 Absorbance of reagent blank The absorbance of reagent blank shall not be less than 0.050 at the wavelength of 450 nm. 3.4 Linear interval The linear correlation coefficient (r) shall not be less than 0.9900 within the linear interval specified by the manufacturer. 3.5 Accuracy Use the traceable standard material to carry out the determination. The deviation between measured value and indicated value shall be within ±10.0%. 3.6 Analysis sensitivity The test kit shall be transported according to the requirements of the manufacturer, and shall be free of moisture, stress, sunshine, rain, snow, acid, alkaline and damage of exterior and interior packaging during the transport. 6.3 Storage Test kit shall be stored under the conditions specified by the manufacturer. .......Source: https://www.ChineseStandard.net/PDF.aspx/YYT1205-2013 |