YY/T 0653-2017 English PDF (YYT0653-2017)

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YY/T 0653-2017: Hematology analyzer
YY/T 0653-2017
Hematology analyzer
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0653-2008
Blood analyzer
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard has been revised on the basis of YY/T 0653-2008, compared with YY/T 0653-2008, except for editorial changes.
The changes are as follows.
--- Revised the scope of application of the standard, changed to "This standard is only applicable to the analysis of the formation of human blood, and provides the phase
a blood analyzer for information (see Chapter 1);
--- The description of the text in the normative reference document is written in accordance with GB/T 1.1-2009;
--- Normative references are not dated, that is, the latest version applies to this standard;
--- Accuracy, precision, linearity, carrying pollution terms and definitions refer to the definition of generic terms already listed in GB/T 29791.1 (see
Chapter 3);
--- Revised the definition of the blood analyzer in terms and definitions, specifically for the detection of human blood specimens (see Chapter 3);
--- Revised the description in the product category, 4.1 modified to "analyzer with only blood cell count function", 4.2 "two-group" was modified to
“Secondary group”, all “semi-automatic, fully automatic” removal (see Chapter 4);
---Modified the atmospheric pressure in normal working conditions, changed to "86.0kPa ~ 106.0kPa", increase Note. 5.1.1 ~ 5.1.4
If the conditions in the manufacturing are inconsistent with the conditions stated in the manufacturing mark, the conditions specified in the product shall prevail (see 5.1);
---Modified linearity, "linear deviation" changed to "allowable deviation range", increased the requirement of linear correlation coefficient, modified HGB linearity
Scope (see 5.3);
--- Revised the comparability of the instrument, changed to accuracy, using fixed-value fresh blood for testing (see 5.4, 6.5);
--- Revised the reference range of normal blood WBC, RBC, HGB, PLT, HCT or MCV in precision (see 5.5.1, 5.6.1)
--- Modified the white-cell classification accuracy test of the five-class analyzer (see 5.6.2);
--- Removed the "Chinese report should be provided" in the basic functions of the analyzer (see 5.7);
--- Increased security requirements (see 5.9);
--- Added electromagnetic compatibility requirements (see 5.11).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. General Hospital of the People's Liberation Army, Beijing Medical Device Inspection Institute, Xisen Meikang Medical Electronics (Shanghai) Co., Ltd.
Company, Changchun Dirui Medical Technology Co., Ltd., Haochang (China) Trading Co., Ltd., Shenzhen Mindray Biomedical Co., Ltd., Bay
Kerman Coulter Trading (China) Co., Ltd.
The main drafters of this standard. Cong Yulong, Xu Yong, Su Jing, Sun Jingsheng, Kang Juan, Chang Shuqin, Liu Ying, Ye Wei, Zhang Hong.
This standard replaces YY/T 0653-2008.
Blood analyzer
1 Scope
This standard specifies the terms and definitions of blood analyzers, product classifications, technical requirements, test methods, labels, markings and instructions for use, and packages.
Loading, transport and storage.
This standard is applicable to blood analyzers (hereinafter referred to as analyzers) that analyze the formation of human blood and provide relevant information.
This standard does not apply to the detection of reticulocyte items.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory - Part 26. Particular requirements
External diagnostic (IVD) medical equipment
GB/T 29791.1 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 1. Terminology, definitions and general
Claim
GB/T 29791.3 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 3. Professional in vitro diagnostics
instrument
Safety of electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
Special requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
An instrument used to detect human blood specimens, to quantify the formation of blood, and to provide relevant information.
Analyzer.
3.2
Semi-automatic semi-automatic
A device that requires an off-site dilution function for blood cell analysis.
Some analysis steps of the instrument or test system are mechanized, and other steps still require operator involvement.
3.3
Fully automatic
A device for blood cell analysis with an internal dilution function.
Means that all analytical steps of the instrument or test system are mechanized, including sample and reagent addition, sample/reagent interaction, and
Learning/biological analysis, result calculation and result reading.
3.4
Accuracy
The degree to which a measured quantity is consistent with a measured true value.
[GB/T 29791.1-2013 definition A.3.24]
3.5
Precision precision
Under the specified conditions, the same or similar objects are repeatedly measured to obtain the degree of agreement between the measured values or the measured values.
[GB/T 29791.1-2013 definition A.3.29]
3.6
Linear linearity
The ability to measure the magnitude directly proportional to the measured value in the sample is given.
[GB/T 29791.1-2013 definition A.3.21]
3.7
Carrying pollution carryover
The introduction of a material that does not belong to it in the reaction mixture.
[GB/T 29791.1-2013 definition A.3.8]
4 Product Categories
4.1 Analyzer with only blood cell count function.
4.2 Dichotomous blood analyzer. An analyzer that can divide white blood cells into large and small binary cells.
4.3 Three-group blood analyzer. an analyzer that can divide white blood cells into large, medium and small three-group cells.
4.4 Five-class blood analyzer. can divide white blood cells into five types (neutrophils, lymphocytes, monocytes, eosinophils, alkaloids)
Analyzer for granulocytes).
5 Technical requirements
5.1 Normal working conditions
5.1.1 Power supply voltage. 220V ± 22V; 50Hz ± 1Hz;
5.1.2 Ambient temperature. 18 ° C ~ 25 ° C;
5.1.3 Relative humidity. ≤80%;
5.1.4 Atmospheric pressure. 86.0kPa~106.0kPa.
Note. When the conditions in 5.1.1~5.1.4 are inconsistent with the conditions stated in the manufacturing mark, the conditions specified in the product shall prevail.
5.2 blank count
The blank count of the analyzer should meet the requirements of Table 1.
Table 1 blank count requirements
Parameter blank count requirement
WBC ≤0.5×109/L
RBC ≤0.05×1012/L
HGB ≤ 2g/L
PLT ≤10×109/L
5.3 Linear
The linear range, linear deviation and linear correlation coefficient of the analyzer should meet the requirements of Table 2.
Table 2 Analyzer Linear Requirements
Parameter linear range allowable deviation range linear correlation coefficient r
WBC
1.0×109/L~10.0×109/L does not exceed ±0.5×109/L
10.1×109/L~99.9×109/L does not exceed ±5%
≥0.990
RBC
0.30×1012/L~1.00×1012/L does not exceed ±0.05×1012/L
1.01×1012/L~7.00×1012/L does not exceed ±5%
≥0.990
HGB
20g/L~70g/L does not exceed ±2g/L
71g/L~200g/L does not exceed ±3%
≥0.990
PLT
20×109/L~100×109/L does not exceed ±10×109/L
101×109/L~999×109/L does not exceed ±10%
≥0.990
5.4 Accuracy
The relative deviation satisfies the requirements of Table 3.
Table 3 accuracy requirements
Parameter detection range allows relative deviation range /%
WBC 3.5×109/L~9.5×109/L does not exceed ±15.0
RBC 3.8×1012/L~5.8×1012/L does not exceed ±6.0
HGB 115g/L~175g/L does not exceed ±6.0
PLT 125×109/L~350×109/L does not exceed ±20.0
HCT or
MCV
35%~50% (HCT) or
82fL~100fL (MCV)
Not exceeding ±9.0 (HCT) or
±7.0 (MCV)
5.5 Semi-automatic analyzer technical requirements
5.5.1 Precision
The precision of the analyzer should meet the requirements of Table 4.
Table 4 Semi-automatic analyzer precision requirements
Parameter detection range precision /%
WBC 3.5×109/L~9.5×109/L ≤6.0
RBC 3.8×1012/L~5.8×1012/L ≤3.0
HGB 115g/L~175g/L ≤2.5
PLT 125×109/L~350×109/L ≤10.0
HCT or
MCV
35%~50% (HCT) or
82fL~100fL (MCV)
≤3.0
≤3.0
5.5.2 Carrying pollution rate
The carrying pollution rate of the analyzer should meet the requirements of Table 5.
Table 5 Carrying pollution rate requirements
Parameter carrying pollution rate requirement /%
WBC ≤1.5
RBC ≤1.0
HGB ≤1.0
PLT ≤ 3.0
5.5.3 Histogram
5.5.3.1 Dichotomous group analyzer
The histogram of normal human fresh blood should be able to clearly show the large and small two groups of cells, and can report the percentage results;
5.5.3.2 Three-group analyzer
The histograms of normal human fresh blood measurements should clearly show the large, medium and small cells, and the percentage results can be reported.
5.6 Fully automatic analyzer technical requirements
5.6.1 Precision
The precision of the analyzer should meet the requirements of Table 6.
Table 6 Precision requirements for fully automatic analyzers
Parameter detection range precision /%
WBC 3.5×109/L~9.5×109/L ≤4.0
RBC 3.8×1012/L~5.8×1012/L ≤2.0
HGB 115g/L~175g/L ≤2.0
PLT 125×109/L~350×109/L ≤8.0
HCT or
MCV
35%~50% (HCT) or
82fL~100fL (MCV)
≤3.0
≤3.0
5.6.2 Five-class analyzer white blood cell classification accuracy
The analyzer's measurement results for neutrophils, lymphocytes, monocytes, eosinophils, and basophils should be tested in accordance with Appendix A.
Within the allowable range of the results obtained by the law (99% confidence interval).
Note. When the reference method test result is 0, and the analyzer test result is ≤1.0%, the test result is qualified.
5.6.3 Carrying pollution rate
The carrying pollution rate of the analyzer should meet the requirements of Table 5.
Table 7 Carrying pollution rate requirements
Parameter carrying pollution rate requirement /%
WBC ≤ 3.5
RBC ≤2.0
HGB ≤2.0
PLT ≤ 5.0
5.7 Analyzer Basic Functions
The analyzer should have the following features.
a) has an abnormal alarm function;
b) has the ability to communicate with the laboratory information system.
5.8 Appearance
The appearance of the analyzer should meet the following requirements.
a) The words and signs should be clearly visible; the surface should be uniform in color, no bumps, no scratches, etc.;
b) The fastener connection should be firm and reliable and must not be loose.
5.9 Security
Meet the requirements of the applicable provisions of GB 4793.1, GB 4793.9, YY 0648.
5.10 Environment
Meet the requirements of the applicable provisions of GB/T 14710.
5.11 Electromagnetic compatibility
Meet the requirements of the applicable provisions of GB/T 18268.1 and GB/T 18268.26.
6 Test methods
6.1 Test conditions
The test conditions shall meet the following requirements.
a) should meet the normal working conditions specified in 5.1;
b) calibrators should be traceable using manufacturer-approved reagents, controls and calibrators;
c) using the manufacturer's recommended anticoagulation method;
d) The analyzer should reach a steady state before the test.
6.2 blank count
The test was performed three times on the analyzer with the diluent as a sample, and the maximum value of the test results was taken three times.
6.3 Linear
6.3.1 Using line nature control products
Operate according to the instructions for the use of the linear property control and calculate the linear deviation and linear correlation coefficient results.
6.3.2 Using high value samples
Take anticoagulated whole blood, centrifuge to remove plasma, make it into concentrated blood cells, and then concentrate the blood cells with their own platelet-poor plasma/diluent
Gradient dilution, at least 5 concentrations, so that the high concentration value is close to the upper limit of the linear range, so that the low concentration value is close to the lower limit of the linear range.
The samples of each concentration were measured on the machine, and each sample was measured 3 times, and the average value of the measurements was calculated. Then use the dilution ratio as the independent variable (X) to each
The average value of the sample is the dependent variable (Y), and the regression equation and the correlation coefficient r are calculated according to equation (1). Find the corresponding points of each concentration point by the regression equation
The theoretical value is calculated as the absolute deviation or relative deviation between the measured mean value and the theoretical value.
r= ∑
(XX)(YY )
∑(XX)2(YY )2
(1)
In the formula.
r---correlation coefficient;
The average value of X---X;
The average value of ...