Calibration of electrolyte analyzer

Calibration of electrolyte analyzer

1. Scope

This regulation is applicable to the determination of K+, Na+, Cl ", Li+, and iCa ²+concentrations in medical applications using ion selective electrode methodCalibration of electrolyte analyzerSubsequent calibration and inspection during use.

2. Reference documents

GB/T 14710-2009 Environmental Requirements and Test Methods for Medical Electrical Appliances

GB/T 6682-2008 Specification and Test Methods for Water Used in Analytical Laboratories

YY/T 0589-2016 Electrolyte Analyzer

For all referenced documents with dates, only the version with dates is applicable to this regulation; The latest version (including all amendments) of any referenced document without a date shall apply to this regulation.

3. Terminology

3.1 Carrying Pollution Rate

The discontinuous amount of analyte carried from one test sample reaction to another by a measurement system, which erroneously affects the performance of another test sample, is usually calculated using a specific formula by cross measuring multiple low value and high value samples given a known nominal value.

4. Overview

The electrolyte analyzer adopts the ion selective electrode method to measure the ion activity in the electrolyte solution by measuring the battery potential composed of the electrolyte solution, ion selective electrode, and reference electrode. The relationship between battery potential and specific ion activity in solution follows the Nernst equation:

Therefore, a known concentration solution is used to calibrate the electrode, a working curve is established in the electrolyte analyzer, and the electrode potential of the sample solution is measured to calculate the concentration of ions in the sample solution. The electrolyte analyzer consists of an injection system, a liquid flow system, a detection system, a data processing system, and a display and printing system, mainly used for clinical electrolyte analysis.

5. Measurement performance requirements

Repeatability, indication error, stability, linearity error, and carrying contamination rate should meet the requirements of Table 1.

6. General Technical Requirements

6.1 The electrolyte analyzer should have complete identification of the following: instrument name, model, factory number, manufacturer name, manufacturing date, rated working power supply voltage and frequency.

6.2 All fasteners should be installed firmly, and the connectors should be well connected and not loose; Each adjustment knob rotates flexibly without any looseness; The buttons and switches should work properly and there should be no damage that affects the normal operation of the electrolyte analyzer.

6.3 The injection system and detection system shall not have any leakage, and the transmission components shall operate normally without any abnormal sound or vibration.

6.4 The digital display of the electrolyte analyzer should be clear and complete.

7. Control of measuring instruments

7.1 Calibration conditions

7.1.1 Calibration environmental conditions

7.1.1.1 Environmental temperature: (15-30) ℃.

7.1.1.2 Relative humidity: ≤ 85%.

7.1.1.3 Power supply: AC voltage (220 ± 22) V, frequency (50 ± 1) Hz, and good grounding.

7.1.1.4 There should be no impact or vibration around the electrolyte analyzer, and there should be no interference from strong electromagnetic fields or strong light exposure.

7.1.2 Calibration standards and supporting equipment

7.1.2.1 National standard substance electrolyte concentration range for inorganic components in human serum. The extended uncertainty of K+concentration (4.0~5.0) mmol/L, Na+concentration (140~150) mmol/L, CI concentration (95~115) mmol/L, Lit concentration (1.1~1.3) mmol/L, and iCa2+(0.9~1.1) mmol/L is better than half of the absolute value required for the indication error of the electrolyte analyzer. Before using the national standard substance for inorganic components and electrolytes in human serum, handle it according to the instructions on the standard substance certificate, pay attention to isothermal mixing with the laboratory, and mix evenly.

7.1.2.2 Standard solution for electrolyte analyzer calibration

The concentration of standard solutions used for electrolyte analyzer calibration of K+, Na+, Cl -, Li+, and iCa+should comply with the specifications in Table 2.

7.1.2.3 Electronic stopwatch

The division value is not greater than 0.1s, and the maximum allowable error is ± 0.5 s/d.

7.2 Calibration Items and Methods

7.2.1 Calibration Items

Calibration items: inspection of appearance and normal operation, repeatability, indication error, stability, linear error, and contamination rate.

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