YY/T 0589-2016Electrolyte analyzer (English PDF)

4.3 Appearance

The appearance shall meet the following requirements:

a) The whole machine shall be complete, without scratches and cracks;

b) The fastener connection shall be firm and reliable, without loosening;

c) There shall be no obvious defects on the surface of metal parts.

4.4 Safety

It shall meet the requirements of the applicable clauses in GB 4793.1 and YY 0648.

4.5 Environmental test

It shall meet the requirements of the applicable clauses in GB/T 14710.

4.6 Electromagnetic compatibility

It shall meet the requirements of the applicable clauses in GB/T 18268.1, GB/T 18268.26.

5.1 Test conditions

Normal working conditions of the instrument:

-- power supply: AC 220 V ± 22 V, 50 Hz ± 1 Hz; or other applicable power supply;

-- ambient temperature: 15 °C ~ 30 °C;

-- relative humidity: not more than 85%;

-- away from interference sources of strong electromagnetic fields.

Note: When the conditions in 5.1 are inconsistent with the manufacturer's product regulations, the product regulations shall prevail. The manufacturer shall state in the product standard.

5.2 Accuracy

For the sample, select a reference substance that has fixed value data based on serum. SD -- standard deviation;

-- the average value of the 10 continuously output measured values.

5.4 Linear

For the sample, select No. 1, No. 2, No. 3, No. 4 and No. 5 K+, Na+, Cl-fixed mass control test solution that is prepared in Table A.1 of Appendix A.

For the sample, select No. 1, No. 2, No. 3, No. 4 and No. 5 iCa2+, Li+ fixed mass control test solution that is prepared in Table A.2 of Appendix A.

Under normal working conditions of the instrument, first, perform the calibration according to the conventional test procedure; then, respectively measure each of the certain value of the mass control test solution continuously for 3 times in sequence; take the average value as the actual-measured value; for each analytical element, there is a group of measured value Y of different concentrations.

Between a group of actual-measured values of different concentrations of each analytical element, Yn, and a group of nominal values of different concentrations corresponding to it, X, firstly, use the linear regression analysis method to calculate the linear regression parameters, a (slope) and b (intercept), of each analytical element; derive the linear regression equation Y = a · X + b of each analytical element.

For each analytical element, substitute a known group of nominal values X of different concentrations into their corresponding linear regression equations to obtain a corresponding group of linear regression values Y.

Respectively calculate the absolute value of absolute deviation or relative deviation of the actual-measured value Yn relative to the linear regression value Y of different concentrations of each analytical element; calculate the correlation coefficient of linear regression |r|, which shall meet the requirements of 4.1.3.

5.5 Stability

For the sample, select No. 3 K+, Na+, Cl-fixed value mass control test solution that is prepared in Table A.1 of Appendix A.

For the sample, select No. 3 iCa2+, Li+ fixed value mass control test solution that is prepared in Table A.2 of Appendix A.

Under normal working conditions of the instrument, first, perform the calibration in accordance with the conventional test procedures; then, test the No. 3 fixed-value mass control test solution; perform the test, respectively, at 0 h, 4 h, and 8 h, and record the measured values of each analytical element; obtain three

Where: CHL -- Carrying pollution rate;

L1 ~ L4 -- the 1st ~ 4th measurement value of each group of low concentration solution;

H1 ~ H4 -- the 1st ~ 4th measurement value of each group of high concentration solution.

5.7 Function

Perform the function test according to the use method of the instruction manual and the operation prompt of the display, which shall comply with the provisions of 4.2.

5.8 Appearance

Visually inspect, which shall meet the requirements of 4.3.

5.9 Safety

Perform according to the test methods of the applicable clauses in GB 4793.1 and YY 0648.

5.10 Environmental test

Perform the test according to applicable test procedures and test methods of

GB/T 14710. During the high temperature storage, low temperature storage, damp heat storage and vibration collision tests, the electrode, pump tube and reagents can be withdrawn; the test results shall meet the requirements of 4.4.

5.11 Electromagnetic compatibility

Perform the test according to the applicable clauses in GB/T 18268.1 and GB/T 18268.26, which shall meet the requirements of 4.6.

6.1 Overview

The text of the signs, labeling and instruction manual must be in Chinese; other languages can be attached. The use of Chinese shall conform to the national language standards. The text, symbols, graphics, tables, numbers, photos, pictures, etc. of the instruction manual, labeling and packaging marks shall be accurate, clear and standardized. The symbols which are used in signs, labeling and instruction manual shall meet the requirements of YY/T 0466.1.

A.1 Equipment

A.1.1 Analytical balance (the maximum weighing is not more than 200 g; the accuracy is 0.1 mg) and weighing bottle with lid.

A.1.2 Volumetric flask (1 000 mL, grade A) and pipette (10 mL, grade A). A.1.3 Electric oven, beaker (100 mL) and dryer.

A.2 Reagent

A.2.1 Potassium chloride [KCl], guaranteed reagent (content >= 99.5%). A.2.2 Sodium chloride [NaCl], guaranteed reagent (content >= 99.5%). A.2.3 Sodium acetate [CH3COONa], guaranteed reagent (content >= 99.0%). A.2.4 Boric acid [H3BO3], guaranteed reagent (content >= 99.0%). A.2.5 Anhydrous lithium chloride [LiCl], guaranteed reagent (content >= 99.0%).

A.2.6 Anhydrous calcium chloride [CaCl2], guaranteed reagent (content >=

99.5%).

A.2.7 Sodium 3-(N-morpholino) propanesulfonate

[MOPSNa], guaranteed reagent (content >= 99.0%). A.2.8 3-(N-morpholino) propanesulfonic acid [MOPS], guaranteed reagent (content >= 99.0%).

A.3 Preparation requirements and methods

A.3.1 Preparation requirements

According to Table A.1, Table A.2, prepare 5-point fixed value mass control test solution.