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JJF 1841-2020 English PDF

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JJF 1841-2020: (Calibration specification for glycosylated hemoglobin analyzer)
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Basic data

Standard ID JJF 1841-2020 (JJF1841-2020)
Description (Translated English) (Calibration specification for glycosylated hemoglobin analyzer)
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 16,110
Date of Issue 2020-07-02
Date of Implementation 2021-01-02
Regulation (derived from) Announcement No. 29 (2020) of the State Administration for Market Regulation
Issuing agency(ies) State Administration for Market Regulation

JJF 1841-2020: (Calibration specification for glycosylated hemoglobin analyzer)

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(Calibration specification for glycosylated hemoglobin analyzer) National Metrology Technical Specification of the People's Republic of China Specification for calibration of glycosylated hemoglobin analyzer Published on 2020-07-02 2021-01-02 Implementation Released by the State Administration for Market Regulation Glycated hemoglobin analyzer Calibration specification Focal Point. National Biometric Technology Committee Main drafting unit. China Institute of Metrology Participating in the drafting unit. Beijing Institute of Metrology and Testing Sciences Nanjing Metrology Supervision and Inspection Institute This specification is entrusted to the National Biometric Technology Committee to be responsible for the interpretation The main drafters of this specification. Mi Wei (China Institute of Metrology) Wu Liqing (China Institute of Metrology) Yang Bin (China Institute of Metrology) Participating drafters. Shen Zhengsheng (Beijing Institute of Metrology and Testing) Zhen Xiaoxiao (Beijing Institute of Metrology and Testing) Chen Hongfei (Nanjing Metrology Supervision and Inspection Institute) Liu Feng (Nanjing Metrology Supervision and Inspection Institute)

content

Introduction (Ⅱ) 1 Scope(1) 2 References (1) 3 Terms and units of measurement(1) 3.1 Terminology (1) 3.2 Units of measurement (1) 4 Overview(1) 5 Metrology Characteristics(2) 6 Calibration Conditions(2) 6.1 Environmental conditions (2) 6.2 Reference materials and reagents (2) 7 Calibration items and calibration methods (2) 7.1 Relative indication error(2) 7.2 Measurement repeatability(3) 7.3 Carry-over rate (if applicable) (3) 7.4 Linear correlation(3) 8 Expression of calibration results (4) 8.1 Calibration result processing (4) 8.2 Measurement uncertainty of calibration results(4) 9 Recalibration interval(4) Appendix A Contents and Formats of Calibration Records and Calibration Certificates (5) Appendix B Relative Indication Error Calibration Uncertainty Evaluation Example(9) Appendix C Preparation of Linear Dependency Calibration Solution(11)

Introduction

JJF 1071 "Rules for Compilation of National Metrology Calibration Specifications", JJF 1001 "General Metrology Terms and Definitions", JJF 1059.1 "Assessment and Representation of Measurement Uncertainty" together constitute the basic series of regulations supporting the formulation of this specification. Fan. The calibration method and measurement characteristics mainly refer to YY/T 1246-2014 "glycated hemoglobin analyzer". This specification is published for the first time. Specification for calibration of glycosylated hemoglobin analyzer

1 Scope

This standard applies to the calibration of glycated hemoglobin analyzers for high performance liquid chromatography and immunoassay, and other methods The instrument is implemented with reference to this specification.

2 Reference documents

This specification references the following documents. JJF 1001-2011 General Metrology Terms and Definitions JJF 1071-2010 Rules for Compilation of National Metrology and Calibration Specifications JJF 1265-2010 Biometric Terms and Definitions GB/T 14666-2003 Analytical Chemistry Terminology YY/T 1246-2014 Glycated hemoglobin analyzer CLSIEP06-A Linear Evaluation of Quantitative Measurement Procedures. Statistical Methods; Approved Guidelines (Evaluation of the Linearity of Quantitative Measurement Procedures.A Statistical Approach; For dated references, only the dated version applies to this specification; for undated references The latest version (including all amendments) applies to this specification.

3 Terminology and units of measurement

3.1 Terminology Terms and definitions as defined in JJF 1001-2011, JJF 1265-2010 and GB/T 14666-2003 and the following The meaning applies to this specification. 3.1.1 Glycated hemoglobin HemoglobinA1c; HbA1c A stable compound in which glucose in human blood is covalently bound to the N-terminal valine residue of the β-chain of hemoglobin. 3.2 Units of measurement 3.2.1 Glycated hemoglobin unit of measure Glycated hemoglobin (HbA1c) in IFCC units (mmol/mol) and derived NGSP units (%) Report. IFCC-NGSP conversion can be used to convert between IFCC unit (mmol/mol) and NGSP unit (%) formula. NGSP value (%)=0.09148×IFCC value (mmol/mol) 2.152. Note. Unless otherwise stated in this specification, glycated hemoglobin refers to HbA1c.

4 Overview

Glycated hemoglobin analyzer (hereinafter referred to as analyzer) is to measure the proportion of glycated hemoglobin in the total hemoglobin in the human body. proportional instrument. The technical principles commonly used in analyzers are mainly divided into two types. high performance liquid chromatography and immunoassay.

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