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JJG 714-2012: Verification Regulation of Blood Cell Analyzers Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid JJG 714: Historical versions
JJG 714-2012: Verification Regulation of Blood Cell Analyzers---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/JJG714-2012JJG METROLOGICAL VERIFICATION REGULATION OF THE PEOPLE’S REPUBLIC OF CHINA Replacing JJG 714-1990 Verification Regulation of Blood Cell Analyzers Issued on: JUNE 18, 2012 Implemented on: DECEMBER 18, 2012 Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes. Verification Regulation of Blood Cell Analyzers Administrative organization. National Technical Committee of Clinical Medicine Metrology Main drafting organization. China National Institute of Metrology Participating drafting organizations. Beijing Institute of Metrology and Testing; Qingdao Institute of Metrology and Testing This Regulation shall be interpreted by the National Technical Committee of Clinical Medicine Metrology. Table of Contents1 Scope ... 5 2 Normative References ... 5 3 General ... 5 4 Metrological Performance Requirements ... 6 5 General Technical Requirements ... 6 6 Control of Measuring Devices ... 6 7 Handlings of Verification Results ... 9 8 Verification Cycle ... 9 Annex A Verification Original Data Log Sheet ... 10 Annex B Format of Inner-Pages of Verification Certificate/Verification Result Letter ... 13 Verification Regulation of Blood Cell Analyzers1 ScopeThis Regulation applies to the initial verification, subsequent verification and in-use verification of blood cell analyzers.2 Normative ReferencesThe following document is referenced in this Regulation. YY/T 0653-2008, Hematology Analyzer For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this Regulation.3 GeneralBlood cell analyzers (hereinafter referred to as analyzers) are capable of measuring the red blood cell count (RBC), white blood cell count (WBC), blood platelet count (PLT) and hemoglobin concentration (HGB) in human blood, which are mainly used for blood tests by hospitals and scientific research departments and other departments. The measuring methods for the red blood cell count in the analyzers include electrical impedance method, laser scattering method, fluorescent staining method and so on. The method widely used is the electrical impedance method; gem hole is used as the sensor; after the sensor absorbs a fixed quantity of blood cell specimen, the blood cell count is converted into the corresponding electrical pulse count. The electrical pulse is amplified, voltage discriminated and shaped; then the blood cell count is determined by measuring the electrical pulse count. The measurement of hemoglobin concentration is generally carried out in accordance with the colorimetric principle; the photoelectric element is used as the sensor; the sensor converts the variation of hemoglobin concentration into the variation of the corresponding voltage signal; the hemoglobin concentration is determined by measuring the variation of voltage after the voltage signal goes through amplification operation. The apparatus consist of mechanical system, electrical system, testing system and control system and so on. apparatus to preheat them; preset all switches and rotary knobs. The apparatus are verified in accordance with the routine procedures if their self-inspection is normal. For the apparatus having mode selection functions, set them to the whole blood measurement mode. Reagents, which are from the manufacturer or whose effectiveness can be proved, shall be used for the apparatus. 6.4.3 Blank value verification Take an appropriate amount of apparatus blank diluent to pour into a clean measuring cup; repeat the measurement for 4 times. Discard the measured value for the first time; record the maximum values of the other 3 measured results, i.e. the blank values of RBC, WBC, PLT, HGB. 6.4.4 Carryover verification Select one kind of standard substances of high and low values; mix up before use. In accordance with the sequence from high values to low values, carry out measurement continuously for 3 times. The measured values are respectively i1, i2, i3 and j1, j2, j3. Calculate the carryovers of RBC, WBC, PLT and HGB in accordance with Formula (1). where, CO—the carryover; i3—the value of standard substance of a high value measured for the third time; j1—the value of standard substance of a low value measured for the first time; j3—the value of standard substance of a low value measured for the third time. 6.4.5 Verification of indication error Take 3 ~ 5 kinds of blood cell standard substances of different concentrations within the commonly-used measuring range of the apparatus (take 5 kinds for the first verification); carry out measurement continuously for 5 times after mixing up respectively; calculate respectively the relative error ΔT of indicating value of the apparatus in accordance with Formula (2); take ΔT having the maximum absolute value as the verification results of the indication error of RBC, WBC, PLT and HGB of the apparatus. where, Ts—the standard value of standard substance;Annex BFormat of Inner-Pages of Verification Certificate/Verification Result Letter B.1 Format of the second page of verification certificate/verification result letter Certificate No. xxxx - xxxx Verification body authorization instructions. Environmental conditions and site for verification Temperature. °C Site. Relative humidity. % Others. Metrological standard apparatus used for verification Name Measuring range Uncertainty/accuracy grade/maximum allowable error Metrological standard certificate no. Valid until Standard instruments used for verification Name Measuring range Uncertainty/accuracy grade/maximum allowable error Metrological standard certificate no. Valid until ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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