YY/T 1155-2019 PDF EnglishUS$245.00 · In stock · Download in 9 seconds
YY/T 1155-2019: Automatic luminescence immunoassay analyzer 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 1155: Historical versions
YY/T 1155-2019: Automatic luminescence immunoassay analyzer---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/YYT1155-2019YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA ICS 11.100 C 44 Replacing YY/T 1155-2009 Automatic luminescence immunoassay analyzer Issued on. MAY 31, 2019 Implemented on. JUNE 1, 2020 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 6 4 Requirements... 6 5 Test methods... 9 6 Labels, markings, and instructions for use... 15 7 Packaging, transportation, and storage... 15 Appendix A (Informative) Densities of pure water at different temperatures under standard atmospheric pressure... 16 References... 17ForewordThis standard was drafted according to the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying these patents. This standard replaces YY/T 1155-2009 Automatic Luminescence Immunoassay Analyzer. Compared with YY/T 1155-2009, the main technical changes except editorial modifications are as follows. -- The content "This standard does not apply to luminescent immunoassay analyzers based on image recognition" is added (see Chapter 1); -- Electromagnetic compatibility standards, special safety standards for in vitro diagnostic equipment, and labeling standards for in vitro diagnostic equipment are added. The specific adjustments are as follows. References to GB 4793.6, GB 4793.9, and YY 0648 are added (see 5.10); References to GB/T 18268.1 and GB/T 18268.26 are added (see 5.11); The reference to GB/T 29791.3 is added (see Chapter 6); YY 0466 is deleted (see Chapter 6 in the 2009 edition). -- In the list of normative references, the year numbers of the listed standards are deleted (see Chapter 2); -- The requirements and corresponding test methods for the accuracy and repeatability of sample addition are added (see 4.1 and 5.2); -- The requirements and corresponding test methods for the accuracy and fluctuation of temperature control in the reaction zone are modified (see 4.2 and 5.3; see 4.1 and 5.3 of the 2009 edition); -- The requirements and the corresponding test methods for light detection devices are added (see 4.3 and 5.4); -- The stability of the analyzer is deleted and the stability of the luminescence value is added (see 4.3.4 and 5.4.4; see 4.2 and 5.4 of the 2009 edition); -- The linear correlation is deleted and the linearity of luminescence value is added (see 4.3.2 and 5.4.2; see 4.4 and 5.6 of the 2009 edition); -- The requirements for carryover of analyzers that can only report qualitative test results are added (see 4.4); -- The intra-batch precision requirements and corresponding test methods for clinical items are modified (see 4.5 and 5.6); -- The safety requirements and test methods specified in GB 4793.6, GB 4793.9, YY 0648 are added (see 4.9 and 5.10); -- Electromagnetic compatibility requirements and test methods specified in GB/T 18268.1 and GB/T 18268.26 are added (see 4.10 and 5.11); -- Labels, markings, and instructions for use are modified they shall comply with the requirements of GB/T 29791.3 (see Chapter 6); -- Appendix A the pure water density table is added (see Appendix A). This standard was proposed by the National Medical Products Administration. This standard shall be under the jurisdiction of the National Technical Committee on Clinical Laboratory Testing and Invitro Diagnostic Test Systems of Standardization Administration of China (SAC/TC136). Drafting organizations of this standard. Beijing Institute of Medical Device Test, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen New Industry Biomedical Engineering Co., Ltd., Autobio Labtec Instruments (Zhengzhou) Co., Ltd., Chemiclin Diagnostics Co., Ltd., Changchun Dirui Medical Technology Co., Ltd., Xiamen Innodx Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Laboratories Trading (Shanghai) Co., Ltd., Beckman Coulter Commercial Enterprise (China) Co., Ltd. Main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei, Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Zang Yulan. The previous versions of the standards replaced by this standard are as follows. -- YY/T 1155-2009. Automatic luminescence immunoassay analyzer1 ScopeThis standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation, and storage of automatic luminescence immunoassay analyzers. This standard applies to automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. Analyzers use luminescent systems and immunoassay methods to quantitatively or qualitatively detect various analytes in human serum, plasma, or other body fluids, including luminescence immunoassay analyzers based on chemiluminescence, electrochemiluminescence, fluorescence, and other principles. This standard does not apply to luminescence immunoassay analyzers based on image recognition and automatic luminescence immunoassay analyzers for point-of-care testing (POCT).2 Normative referencesThe following documents are essential for the application of this document. For any referenced document with a date, only the version with the date applies to this document. For any referenced document without a date, 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 4793.6 Safety requirements for electrical for measurement, control, and laboratory use - Part 6.Particular requirements for laboratory equipment for the heating of materials 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 equipment3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 luminescence immunoassay A method that combines a luminescent system with an immune response to detect antigens or antibodies. 3.3 automatic luminescence immunoassay analyzer A luminescence immunoassay analyzer by which all analytical processes including the injection of samples and reagents, the provision of the immune binding reaction environment, data measurement, result calculation and output are implemented automatically.4 Requirements4.1 Accuracy and repeatability of sample addition The minimum and maximum sample loading volumes and the minimum and maximum reagent loading volumes specified on the instrument shall be tested and shall comply with the requirements of Table 1. 4.3 Light detection device 4.3.1 Instrument noise The manufacturer's specifications shall not be exceeded. 4.3.2 Linearity of luminescence values In the range of no less than 3 luminescence value orders of magnitude, the linear correlation coefficient (r) shall be ≥0.99. 4.3.3 Repeatability of luminescence values 4.3.4 Stability of luminescence values 4.4 Carryover The carryover rate shall be ≤10-5.For analyzers that can only report qualitative test results, negative samples cannot be tested as positive after high-concentration positive samples are tested. 4.5 Intra-batch precision of clinical items Select at least one clinical item and conduct the intra-batch precision test using the calibrators and kits specified by the manufacturer. The intra-batch precision shall comply with the requirements of the corresponding national standards and industry standards. 4.6 Main functions of the analyzer The analyzer shall have the following main functions. 4.7 Appearance The appearance of the analyzer shall meet the following requirements. 4.8 Environmental test requirements It shall meet the requirements of climate environment group I and mechanical environment group I in GB/T 14710. 4.9 Security requirements It shall comply with the requirements of applicable clauses in GB 4793.1, GB 4793.6, GB 4793.9, and YY 0648.5 Test methods5.1 Normal working environment conditions 5.1.1 Power supply voltage. 220 V±22 V; 50 Hz±1 Hz; 5.2 Accuracy and repeatability of sample addition There are two types of determination methods. colorimetry and weighing method. Manufacturers can choose either method. 5.2.1 Weighing method The weighing method is carried out according to the following steps. 5.2.2 Colorimetry The colorimetric method is carried out according to the following steps. 5.3 Accuracy and fluctuation of temperature control in the reaction zone Place the probe of a temperature detector with a resolution of not less than 0.1 °C, or a calibrated special temperature measuring tool with the same accuracy provided by the analyzer manufacturer, at the location specified by the manufacturer. 5.4 Light detection device 5.4.1 Instrument noise After the analyzer is turned on and in a stable working state, use a blank sample to test for 20 consecutive times, record the luminescence value of each test, calculate the arithmetic mean 𝐼 ̅ of the luminescence values, and calculate the instrument noise IB according to formula (5), which shall meet the requirements of 4.3.1. 5.4.2 Linearity of luminescence values One of the following two methods can be chosen. 5.6 Intra-batch precision of clinical items Using calibrators and kits for the clinical test item specified by the manufacturer, test the intra-batch precision in accordance with the corresponding national standards, industry standards, or test kit technical requirements, which shall comply with the provisions of 4.5. 5.7 Main functions of the analyzer The verification is performed according to the instructions; the functions shall meet the requirements of 4.6. 5.8 Appearance Visual inspection is carried out; the appearance shall comply with the requirements of 4.7. 5.9 Environmental test requirements The test is carried out according to the method specified in GB/T 14710.The results shall meet the requirements of 4.8. 5.10 Security requirements The test is carried out according to the methods specified in GB 4793.1, GB 4793.6, GB 4793.9, and YY 0648, and the results shall meet the requirements of 4.9.6 Labels, markings, and instructions for useThey shall comply with the requirements of GB/T 29791.3.7 Packaging, transportation, and storage7.1 Packaging The packaging of the analyzer shall comply with the following provisions. 7.2 Transportation Transportation shall be carried out in accordance with the requirements specified by the manufacturer. 7.3 Storage Storage shall be carried out in accordance with the manufacturer's instructions. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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