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JJG 1051-2021: (Electrolyte Analyzer Verification Regulations)
Status: Valid JJG 1051: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JJG 1051-2021 | English | 439 |
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(Electrolyte Analyzer Verification Regulations)
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JJG 1051-2021
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| JJG 1051-2009 | English | 719 |
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Verification Regulation for Electrolyte Analyzers
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JJG 1051-2009
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| JJG 1051-1996 | English | RFQ |
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Designation for Working Measuring Instrument and its Classification Code
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JJG 1051-1996
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PDF similar to JJG 1051-2021
Basic data | Standard ID | JJG 1051-2021 (JJG1051-2021) | | Description (Translated English) | (Electrolyte Analyzer Verification Regulations) | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A61 | | Word Count Estimation | 22,23 | | Issuing agency(ies) | State Administration for Market Regulation | JJG 1051-2021: (Electrolyte Analyzer Verification Regulations)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Electrolyte Analyzer Verification Regulations)
People's Republic of China National Metrological Verification Regulations
Electrolyte Analyzer
2022-01-28 Implementation
Released by the State Administration for Market Regulation
Electrolyte analyzer verification procedures
Replacing JJG 1051-2009
Focal Point. National Clinical Medicine Metrology Technical Committee
Drafting unit. Heilongjiang Provincial Institute of Metrology, Verification and Testing
Shenzhen Kite Biomedical Electronic Technology Co., Ltd.
This regulation is entrusted to the National Clinical Medicine Metrology Technical Committee to be responsible for the interpretation
The drafters of this regulation.
Ding Haiming (Heilongjiang Institute of Metrology, Verification and Testing)
Wu Guoqiang (Shenzhen Kate Biomedical Electronic Technology Co., Ltd.)
content
Introduction (Ⅱ)
1 Scope(1)
2 References (1)
3 Terms (1)
4 Overview(1)
5 Measurement performance requirements (2)
6 General technical requirements (2)
7 Measuring Instrument Control(2)
7.1 Verification Conditions (2)
7.2 Verification items and verification methods (3)
7.3 Processing of Verification Results (6)
7.4 Verification Period(6)
Appendix A Calculation of Slope and Intercept in Linear Regression(7)
Appendix B Preparation method of standard solution for verification (8)
Appendix C Verification Record Format (10)
Appendix D Verification Certificate/Inner Page Format of Verification Result Notification (15)
Introduction
This regulation is compiled in accordance with JJF1002-2010 "Rules for Compilation of National Metrological Verification Regulations". This regulation is for
Revision of JJG 1051-2009 "Electrolyte Analyzer". Compared with JJG 1051-2009, except for editorial changes,
The main technical changes are as follows.
--- The term "cross-contamination rate" is changed to "carry-over contamination rate" (see Chapter 3);
--- Added the relevant content of Li and iCa2 (see Chapter 5);
--- Modified the indication error requirements of K, Na, Cl- (see Chapter 5);
---Appendix B adds the preparation method of Li, iCa2 linear solution.
The previous versions of this regulation have been released as follows.
---JJG 1051-2009.
Electrolyte analyzer verification procedures
1 Scope
This regulation applies to the use of ion-selective electrode method to determine the concentration of K, Na, Cl-, Li, iCa2 in medical
Initial verification, subsequent verification and in-use inspection of electrolyte analyzers.
2 Reference documents
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 6682-2008 Specifications and test methods for water used in analytical laboratories
YY/T 0589-2016 Electrolyte Analyzer
For dated references, only the dated version applies to this regulation; for undated references
The latest version (including all amendments) applies to this regulation.
3 Terminology
3.1 Carry-overrate
The discrete amount of analyte carried by the measurement system from one test sample reaction to another test sample reaction, determined by
This erroneously affects the performance of another test sample. Usually given a low value sample and a high value of a known nominal setting
Value samples are cross-measured multiple times and calculated using a specific formula.
4 Overview
The electrolyte analyzer adopts the ion-selective electrode method.
The battery potential formed by the specific electrode is used to measure the ionic activity in the electrolyte solution. Cell potential and specific ionization in solution
The relationship of the sub-activity conforms to the Nernst equation.
E=E0±
RT
nFlnαx
(1)
αx=fx·cx (2)
where.
E---Measure battery potential, mV;
E0---Measure the initial potential value of the battery, mV;
R---gas constant, 8.3145J/(K mol);
T---thermodynamic temperature of the solution to be tested, K;
n---the valence of the tested ion participating in the electrode reaction;
F---Faraday constant, 96485C/mol;
αx---the activity of the measured ion, mol/L;
fx---activity coefficient;
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