YY/T 1523-2017 PDF EnglishUS$140.00 · In stock · Download in 9 seconds
YY/T 1523-2017: Bicarbonate Assay Kit (PEPC Enzymatic Method) 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 1523-2017: Bicarbonate Assay Kit (PEPC Enzymatic Method)---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/YYT1523-2017YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 Bicarbonate Assay Kit (PEPC Enzymatic Method) Issued on: MARCH 28, 2017 Implemented on: APRIL 01, 2018 Issued by. China Food and Drug Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative References ... 4 3 Requirements ... 4 4 Test Methods ... 6 5 Label and Use Instructions ... 9 6 Package, Transportation and Storage ... 10 Bibliography ... 11 Bicarbonate Assay Kit (PEPC Enzymatic Method)1 ScopeThis Standard specifies the requirements, test methods, label and use instructions, package, transportation and storage of bicarbonate assay kit. This Standard is applicable to the reagent kit performing quantitative detection (hereinafter referred to as kit) against the carbon dioxide in the human serum or plasma by phosphoenolpyruvate carboxylase (PEPC) enzymatic method, including the reagent used by manual, semi-automatic, fully automatic biochemistry analyzer.2 Normative ReferencesThe following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. GB/T 29791.2 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional Use3 Requirements3.1 Appearance The appearance of kit shall meet the following requirements. a) The components of kit shall be complete and intact; there is no liquid leakage; b) The text and symbols of package label shall be clear. 3.2 Loading amount It shall be no less than the marked value. 3.3 Reagent blank absorbance certain period of time after the expiration date; test the reagent blank absorbance, analytical sensitivity, linear, repeatability, accuracy, which shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7. 3.8.3 Thermal stability test Test the reagent blank absorbance, analytical sensitivity, linear, repeatability, accuracy, which shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7. NOTE 1. Thermal stability cannot be used to derive the valid date of the product; unless it is from a derivation formula based on a large number of stability studies. NOTE 2. Generally, a product with a valid period of 1 year and no more than 1 month is selected; the valid period shall be half a year; and so on. However, if it exceeds the specified time, when the product meets the requirements, it is also acceptable. NOTE 3. According to the product characteristics, any combination of the methods specified in 3.8.2, 3.8.3 can be selected; but the selected method shall be able to verify the stability of the product to ensure that the product performance meets the standard requirements with the shelf life period.4 Test Methods4.1 Basic requirements of instrument Spectrophotometer or biochemical analyzer, the wavelength range shall meet the requirements for reagent use; biochemical analyzer shall be equipped with thermostat (temperature value shall be within ±0.3°C of the setting value; fluctuation shall be no greater than ±0.2°C); the absorbance measurement resolution shall be 0.001 above. 4.2 Appearance Take visual examination with normal or corrected visual acuity under natural light, the results shall meet the requirements of 3.1. 4.3 Loading amount Use general measuring gauge to measure; it shall meet the requirements of 3.2. 4.4 Reagent blank absorbance Use reagent kit to test the blank sample; record the absorbance value at the dominant wavelength of the reading point specified in the reagent kit parameters; which shall meet the requirements of 3.3. NOTE. The blank sample can be pure water sample, saline, zero calibration solution, and the Xi – measurement concentration; T – calibrated concentration of reference material. 4.8.3 Recovery test Add certain volume of standard solution or pure product to human sample (the volume ratio between standard solution and human sample shall not generate matrix change; after adding the standard solution, the total concentration of the sample shall be within the linear range of the kit); each concentration shall be test for 3 times; calculate the average value; calculate the recovery rate as per the Formula (5), which shall meet the requirements of 3.7b). Where. R – recovery rate; V – volume of the added standard solution; V0 – volume of human sample; C – mean concentration of detection after human sample is added standard solution; C0 – mean concentration of detection of human sample; Cs – concentration of standard solution. 4.9 Stability 4.9.1 Shelf life stability Take the sample after the expiration date, test as per the method specified in 4.4, 4.5, 4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.2. 4.9.2 Thermal stability test Take the sample within the shelf life of product, according to the manufacturer claimed thermal stability conditions, test as per the methods specified in 4.4, 4.5, 4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.3.5 Label and Use InstructionsIt shall meet the requirements of GB/T 29791.2. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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