GB/T 26124-2011 PDF EnglishUS$290.00 · In stock · Download in 9 seconds
GB/T 26124-2011: In Vitro Diagnostic Reagent (kit) for Clinical Chemistry Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsGB/T 26124-2011: In Vitro Diagnostic Reagent (kit) for Clinical Chemistry---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/GBT26124-2011GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 In Vitro Diagnostic Reagent (kit) for Clinical Chemistry Issued on. MAY 12, 2011 Implemented on. NOVEMBER 1, 2011 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Naming and Classification... 9 5 Requirements... 9 6 Test Methods... 11 7 Markings, Labels and Instructions for Use... 15 8 Packaging, Transportation and Storage... 22 Bibliography... 23ForewordThis Standard was drafted in accordance with the rules in GB/T 1.1-2009 Directives for Standardization - Part 1.Structure and Drafting of Standards. Please be noted that certain content of this document might involve patents. The institution issuing this document does not undertake the responsibility of identifying these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee 136 on System of Medical Clinical Test Lab and In Vitro Diagnostic System of Standardization Administration of China (SAC/TC 136). The drafting organization of this Standard. Beijing Institute of Medical Device Testing. The main drafters of this Standard. Bi Chunlei, Liu Yi, Zhang Hong, Wang Jun, Hu Dongmei. In Vitro Diagnostic Reagent (kit) for Clinical Chemistry1 ScopeThis Standard specifies the general technical requirements for the quality inspection of in vitro diagnostic reagent (kit) for clinical chemistry [hereinafter referred to as “reagent (kit)”], including terms and definitions, classification and naming, requirements, test methods, labels and instructions for use, packaging, transportation and storage. This Standard is applicable to in vitro diagnostic reagents (kits) based on the principle of spectrophotometry used in the quantitative inspection of clinical chemistry items in medical laboratories. This Standard does not apply to. a) Performance evaluation reagents (for example, reagents for research purposes only); b) In vitro diagnostic reagents for clinical chemistry in POCT (Point of Care Testing).2 Normative ReferencesThe following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB 3100 The International System of Units and Its Application YY 0466-2003 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied YY/T 0638 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Biological Samples - Metrological Traceability of Assigned Values for Catalytic Concentration of Enzymes in Calibrators and Control Materials3 Terms and DefinitionsThe following terms and definitions are applicable to this Standard. 3.1 In Vitro Diagnostic Reagent In vitro diagnostic reagent refers to the chemical, biological or immunological components, solutions or preparations that are expected to be used by the manufacturer as an in vitro diagnostic medical device. 3.2 Clinical Chemistry Reagent Clinical chemistry reagent refers to an in vitro diagnostic reagent based on the principle of spectrophotometry used in the quantitative inspection of clinical chemistry items in medical laboratories. 3.3 Kit Kit refers to a set of components packaged together to complete a specified in vitro diagnostic test. 3.4 Accuracy Accuracy refers to the degree of consistency between a measured value and an acceptable reference value. 3.5 Reference Material Reference material refers to a material or substance that has one or multiple sufficiently uniform and well-determined characteristics to calibrate measurement devices, evaluate measurement methods or assign values to materials. 3.6 Certified Reference Material; CRM Certified reference material refers to a reference material with an attached certificate; one or multiple characteristic values are determined by an established traceability procedure, so that it can be traced to an accurate reproducible measurement unit representing the characteristic value. Each certified characteristic value is accompanied by the uncertainty of a given confidence level.4 Naming and Classification4.1 Naming The product name of in vitro diagnostic reagents (kits) for clinical chemistry shall include the Chinese name of the corresponding test item, and if necessary, the English (abbreviated) name may be added. 4.2 Classification The composition, specifications and detection principle of the reagents (kits) shall be described.5 Requirements5.1 Appearance The appearance shall comply with the normal appearance requirements specified by the manufacturer. 5.2 Net Weight The net weight of liquid reagents shall be not less than the indicated value. 5.3 Reagent Blank 5.4 Analytical Sensitivity When the reagents (kits) are used to test n units of tested object, the difference in absorbance (A) or the change rate of absorbance (A/min) shall comply with the range provided by the manufacturer. 5.5 Linearity Range The analytical performance within the linearity range of the reagents (kits) shall comply with the following requirements. 5.6 Precision of Measurement 5.7 Accuracy The accuracy of the reagents (kits) shall comply with the requirements specified by the manufacturer. 5.8 Stability The following methods may be selected for the verification of stability.6 Test Methods6.1 Basic Requirements for Instruments Spectrophotometer or biochemical analyzer. the wavelength range covers 340 nm to 700 nm. The biochemical analyzer shall be equipped with a constant-temperature device (precision ± 0.1 °C). The precision of absorbance measurement is above 0.001. 6.4 Reagent Blank 6.4.1 Use the designated blank samples to test the reagents (kits). At the main wavelength of the test, record the absorbance (A1) at the start of the test and the absorbance (A2) after about 5 min (t). The test result of A2 is the measured value of the 6.5 Analytical Sensitivity Use samples with already-known concentration or activity to test the reagents (kits); record the absorbance change generated under the specified parameters of the reagents (kits). Convert it to the difference in absorbance (A) of n units, or, the change rate of absorbance (A/min) of n units, which shall comply with the requirements of 5.4. 6.6 Linearity Range 6.7 Precision of Measurement 6.7.1 Repeatability Under repeatability conditions, use the control materials to test the reagents (kits); repeat the test for at least 10 times (n ≥ 10). Respectively calculate the average value (x) and standard deviation (s) of the measured values. In accordance with Formula (1), calculate the coefficient of variation (CV), which shall comply with the requirements of 5.6.1. 6.7.2 Within-run difference between bottles Use the control materials to respectively test 10 bottles with the same batch number. In addition, calculate the average value (x1) and standard deviation (s1) of the 10 measured values. 6.7.3 Between-run difference Use the control materials to respectively test reagents (kits) with 3 different batch numbers. For each batch number, test 3 times. Respectively calculate the average value xi (i = 1, 2, 3) of the 3 tests of each batch. In accordance with Formula (4) and Formula (5), calculate the relative deviation (R), which shall comply with the requirements of 5.6.3. 6.9 Stability The following methods may be selected for the verification of stability.7 Markings, Labels and Instructions for Use7.1 General Requirements The markings, labels and instructions for use shall comply with the following requirements. 7.2 Markings and Labels of Outer Container The markings and labels of the outer container shall include the following information. 7.3 Markings and Labels of Immediate Container If the immediate container is also the outer container, then, the requirements of 7.2 also apply. 7.4 Instructions for Use The instructions for use shall provide the following information.8 Packaging, Transportation and Storage8.1 Packaging The packaging shall comply with the following requirements. 8.2 Transportation Transport in accordance with the conditions specified in the contract. 8.3 Storage Store in accordance with the specified conditions. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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