YY/T 1825-2021Guideline for measurement uncertainty evaluation of the certified values using the erythrocytes and leucocytes reference measurement procedures (English PDF)
红细胞和白细胞计数参考测量程序定值结果测量不确定度评定指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
December 1, 2022
Scope
YY/T 1825-2021 is the English-translated version of 红细胞和白细胞计数参考测量程序定值结果测量不确定度评定指南.
YY/T 1825-2021 is the Chinese pharmaceutical industry standard that guides the evaluation of measurement uncertainty for the results of the reference measurement procedures for red and white blood cell counts.
It sets out the sources of uncertainty in such a procedure - the dilution, the volume measured, the counting itself and the repeatability between operators and days - and how each component is estimated, combined and expanded, so that a reference laboratory can state its result with an uncertainty that others can rely on. Issued on 6 December 2021, it has applied since 1 December 2022.
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Document preview — YY/T 1825-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
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.
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: JJF 1001-2011, 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;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
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Related Standards
GB/T 29791.1-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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