YY/T 0589-2016 English PDF (YYT0589-2016)

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YY/T 0589-2016: Electrolyte analyzer
YY/T 0589-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 0589-2005
Electrolyte analyzer
ISSUED ON: MARCH 23, 2016
IMPLEMENTED ON: JANUARY 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Classification and basic parameters ... 6 
4 Requirements ... 7 
5 Test method ... 8 
6 Signs, labeling, instruction manual ... 12 
7 Packaging, transportation and storage ... 14 
Appendix A (Normative) Preparation method of fixed value mass control test
solution ... 15 
Electrolyte analyzer
1 Scope
This Standard specifies the classification and basic parameters, requirements,
test methods, signs, labeling, instruction manual and packaging, transportation,
and storage of electrolyte analyzers.
This Standard applies to electrolyte analyzers which use ion-selective
electrodes as sensors (hereafter referred to as instruments); the instruments
are suitable for human clinical electrolyte testing. The electrolyte module on the
biochemical analyzer can refer to this Standard.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB/T 191, Packaging - Pictorial marking for handling of goods
GB 4793.1, Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1: General requirements
GB/T 14710, Environmental requirement and test methods for medical
electrical equipment
GB/T 18268.1, Electrical equipment for measurement, control and laboratory
use - EMC requirements - Part 1: General requirements
GB/T 18268.26, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 26: Particular requirements - In
vitro diagnostic (IVD) medical equipment
YY/T 0466.1, Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements
YY 0648, Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
4.2.4 Save and print the measurement data of the instrument.
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 Test method
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 Signs, labeling, instruction manual
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 ...