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YY/T 1825-2021: Guideline for measurement uncertainty evaluation of the certified values using the erythrocytes and leucocytes reference measurement procedures
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YY/T 1825-2021: Guideline for measurement uncertainty evaluation of the certified values using the erythrocytes and leucocytes reference measurement procedures

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Guideline for measurement uncertainty evaluation of the certified values using the erythrocytes and leucocytes reference measurement procedures ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Red blood cell and white blood cell count reference measurement procedure Guidelines for the Evaluation of Measurement Uncertainty of Fixed Value Results Published on 2021-12-06 2022-12-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting: Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: Beijing Medical Device Inspection Institute, National Health Commission Clinical Inspection Center, Shanghai Clinical Inspection Center, China National Accreditation Center for Conformity Assessment, Sysmex Medical Electronics (Shanghai) Co:, Ltd:, Shenzhen Mindray Biomedical Electronics Co:, Ltd: Division, Beckman Coulter Trading (China) Co:, Ltd: The main drafters of this document: Song Wei, Peng Mingting, Xu Chong, Fu Yue, Su Jing, Shi Xiaoyong, Li Jinzhi: Red blood cell and white blood cell count reference measurement procedure Guidelines for the Evaluation of Measurement Uncertainty of Fixed Value Results

1 Scope

This document gives guidelines for assessing the measurement uncertainty of the results of a reference measurement procedure for red blood cell and white blood cell counts: This document applies to the measurement of the results of reference measurement procedures for the evaluation of red blood cell and white blood cell counts by reference measurement laboratories for blood cell analysis: uncertainty:

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 29791:1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1: Terms, definitions and general Require

3 Terms and Definitions

The terms and definitions defined in GB/T 29791:1 and the following terms and definitions apply to this document: 3:1 referencemeasurementprocedure Accepted as a measurement procedure that provides measurement results suitable for its intended use, including the evaluation of other The correctness of measurement, calibration or assignment of reference substances to the values measured by the measurement procedure: [Source: ISO 15193:2009, 3:7] 3:2 Type A evaluation of measurement uncertainty typeAevaluationofstandarduncertainty Type A evaluation typeAevaluation The evaluation of the measurement uncertainty component by the method of statistical analysis for the quantity measured under the specified measurement conditions: [Source: JJF1001-2011, 5:20] 3:3 Type B assessment of measurement uncertainty typeBevaluationofstandarduncertainty Type B evaluation typeBevaluation An assessment of a measurement uncertainty component by a method other than the Type A assessment of measurement uncertainty: Example: Rating based on the following information: --- Quantity values issued by authoritative institutions; --- Quantity of certified reference substances; --- Calibration certificate; --- instrument drift; --- the accuracy level of the certified measuring instrument; ...