YY/T 1582-2018 PDF EnglishUS$230.00 · In stock · Download in 9 seconds
YY/T 1582-2018: Colloidal gold immunochromatography reader Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 1582-2018: Colloidal gold immunochromatography reader---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1582-2018YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.100 C 44 Colloidal gold immunochromatography reader Issued on. FEBRUARY 24, 2018 Implemented on. MARCH 01, 2019 Issued by. State Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Requirements... 5 4 Test method... 7 5 Labels and instructions for use... 11 6 Packaging, transportation and storage... 12 Appendix A (Informative) Preparation and measurement calibration method of quality control strip... 14 References... 19ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard shall be under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136). Drafting organizations of this standard. Beijing Medical Device Technology Review Center, Beijing Medical Device Inspection Institute, Beijing Lepu Medical Technology Co., Ltd., Institute of Optics and Laser Metrology of Chinese Academy of Metrology. The main drafters of this standard. Jiang Yan, Yan Juan, Chen Yongqiang, Lv Liang. Colloidal gold immunochromatography reader1 ScopeThis standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of colloidal gold immunochromatography analyzers. This standard is applicable to instruments that interpret the results of samples by measuring the reflectivity of the bands in the reaction zone of the colloidal gold reagent card (hereinafter referred to as analyzers). This standard does not apply to instruments that use fluorescent labels or other labeling methods for rapid immunoassay.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial marking for handling of goods GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1.General requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9.Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes GB/T 14710 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1.General requirements3 Requirements3.1 Appearance The following requirements shall be met when applicable. 3.2 Resolution It may choose one of the following methods. 3.3 Accuracy According to the following priority order, one of the following methods can be selected. 3.4 Repeatability It may choose one of the following methods. 3.5 Linearity It may choose one of the following methods. 3.6 Channel consistency (if applicable) Test the quality control strip, the relative range (Rp) of the measurement results of each channel shall not be greater than 5%. 3.7 Stability Test the quality control strip, the relative range (R) shall not exceed 5%. 3.8 Function At least the following functions shall be included; the enterprise shall also determine other functions according to the characteristics of the product. 3.9 Safety requirements It shall meet the requirements of applicable clauses in GB 4793.1, GB 4793.9, YY 0648.4 Test method4.1 Normal working conditions 4.1.1 Power supply voltage. AC 220 V; frequency. 50 Hz. 4.1.2 Ambient temperature. 10 °C ~ 30 °C. 4.1.5 The reflectivity of the quality control strip used in the test methods of 4.3, 4.4, 4.5, 4.6, 4.7 shall be traceable with reference to the method described in Appendix A; the preparation and assignment methods shall be clearly defined. 4.2 Appearance Visual inspection with normal vision or corrected vision under natural light shall meet the requirements of 3.1. 4.3 Resolution 4.4 Accuracy 4.4.1 Relative deviation Use matching reagents to test certified reference materials. The measured value is recorded as (Xi). Use the formula (1) to respectively calculate the relative deviation B. If the three measurement results meet the requirements of 3.3a), it is deemed qualified. If more than or equal to 2 measurement results do not meet, it is judged as unqualified. If one measurement does not meet the requirements, it shall make 20 tests continuously again; use the formula (1) to calculate the relative deviation. If greater than or equal to 19 measurement results meet the requirements of 3.3a), it is judged as qualified. 4.5 Repeatability 4.5.1 Test quality control strip Test the 3 quality control strips with high, medium and low reflectivity in the reflectivity range of [0.20, 0.80]; repeat the measurement 10 times; calculate the average (M) and standard deviation (SD) of the 10 measurement results; calculate the coefficient of variation (CV) according to formula (2), which shall meet the requirements of 3.4a). 4.6 Linearity 4.6.1 Test quality control strip Test at least 5 quality control strips with evenly distributed reflectivity in [0.20, 0.80]; each quality control strip is tested 3 times; use the formula (3) to calculate the correlation coefficient (r) of linear regression, which shall meet the requirements of 3.5a). 4.7 Channel consistency (if applicable) Test the quality control strip which has a reflectivity range of [0.30, 0.40]; measure the same quality control strip 3 times for each channel. Calculate the arithmetic average () and total average () of the measured values of each channel. Use formula (4) to calculate the relative range (Rp) of the measurement results of each channel, which shall meet the requirements of 3.6. 4.8 Stability Test the quality control strip which has a reflectivity signal value within the measurement range of the instrument. 4.9 Function Perform verification in accordance with the instructions and it shall meet the requirements of 3.8. 4.10 Safety requirements Perform test according to the method specified in GB 4793.1, GB 4793.9, YY 0648, the results shall meet the requirements of 3.9. 4.11 Electromagnetic compatibility Perform test according to the method specified in GB/T 18268.1 and GB/T 18268.26, the results shall meet the requirements of 3.10. 4.12 Environmental test Perform test according to the method specified in GB/T 14710, the results shall meet the requirements of 3.11.5 Labels and instructions for use5.1 General It shall meet the requirements of GB/T 29791.3. 5.2 Label The analyzer's label shall be clearly attached in a prominent position and provide at least the following information. 5.3 Instruction manual The instruction manual shall meet the requirements of the Provisions on the Administration of Medical Device Instructions and Labels; it shall at least include the following.6 Packaging, transportation and storage6.1 Packaging The packaging shall meet the following requirements. 6.2 Transportation Transport in accordance with the requirements set by the manufacturer. 6.3 Storage Store it in accordance with the requirements specified by the manufacturer. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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