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YY/T 0653-2008 English PDF (YYT0653-2008)

YY/T 0653-2008 English PDF (YYT0653-2008)

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YY/T 0653-2008: Hematology analyzer

This Standard specifies the terms and definitions, classification, requirements, test methods, labels and instructions, packaging, transportation and storage of hematology analyzers. This Standard applies to hematology analyzers (hereinafter referred to as analyzers), which qualitatively and quantitatively analyze the tangible components in human blood and provide relevant information.
YY/T 0653-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
Hematology analyzer
ISSUED ON. APRIL 25, 2008
IMPLEMENTED ON. JUNE 1, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Product classification ... 6
5 Technical requirements ... 6
6 Test methods ... 9
7 Labels and instructions ... 11
8 Packaging, transportation and storage ... 13
Annex A (normative) Five-classifying test method ) ... 14
Bibliography ... 17
Foreword
Annex A of this Standard is normative.
This Standard is proposed by China Food and Drug Administration.
This Standard is under the jurisdiction of National Technical Committee on Medical Clinical Laboratory and In Vitro Diagnostic System of Standardization Administration of China.
Drafting organizations of this Standard. Sysmex Medical Electronics (Shanghai) Co., Ltd., Beijing Medical Device Testing Institute, American Beckman Coulter Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Jiangxi Tekang Technology Co., Ltd., Guilin High-tech Zone Po Litai Medical Electronics Co., Ltd., Abbott Company. Main drafters of this Standard. Cong Yulong, Zhang Hong, Ling Li, He Yanfeng, Yan Xiao, Xu Yong, Tang Xuehui, Zhang Sihua.
Hematology analyzer
1 Scope
This Standard specifies the terms and definitions, classification, requirements, test methods, labels and instructions, packaging, transportation and storage of hematology analyzers.
This Standard applies to hematology analyzers (hereinafter referred to as analyzers), which qualitatively and quantitatively analyze the tangible components in human blood and provide relevant information.
This standard does not apply to reticulocyte analyzers.
2 Normative references
The following standards contain provisions which, through reference in this Standard, constitute provisions of this Standard. For dated reference, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this Standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. GB/T 191-2008 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 4793.1-2007, IEC 61010- 1.2001, IDT)
GB/T 14710 The environmental requirements and test methods for medical
electrical equipment
YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (ISO 15223.2000, IDT)
3 Terms and definitions
The following terms and definitions apply to this Standard.
3.1
[JJF 1001-1998, definition 5.6]
3.6
linearity
The proportional correlation between the states of two sets of measured values or between the measured values obtained by two methods.
[NCCLS EP10-A2]
3.7
carry-over
The amount of analyte discontinuity of one measurement system carrying one measurement sample reaction to another measurement reaction sample, thereby erroneously affecting the expression quantity of the other detection sample. [NCCLS EP10-A2]
4 Product classification
4.1 The hematology analyzer without white blood cell grouping function. 4.2 Two-grouping hematology analyzer. semi-automatic hematology analyzer capable of dividing the white blood cells into large and small groups.
4.3 Three-grouping hematology analyzer. automatic hematology analyzer capable of dividing the white blood cells into large, medium and small groups.
4.4 Five-classifying hematology analyzer. automatic hematology analyzer capable of classifying the white blood cells into five categories (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
5 Technical requirements
5.1 Normal working conditions
5.1.1 Power supply voltage. 220 V ?? 22 V; 50 Hz ?? 1 Hz.
5.1.2 Ambient temperature. 18 ??C ~ 25 ??C.
5.1.3 Relative humidity. ??? 80 %.
5.1.4 Atmospheric pressure. the atmospheric pressure condition claimed by the 6.3.2 Use high value samples
TAKE anticoagulation whole blood, CENTRIFUGE to remove the plasma, making it into concentrated blood cells; gradiently dilute the concentrated blood cells with their own platelet plasma/dilution, dilute to at least 5 concentrations, so that the high concentration value is close to the upper limit of the linear range and the low concentration value is close to the lower limit of the linear range. MEASURE the blood samples of each concentration gradient on the instrument, each sample is measured 3 times, TAKE the mean value. TAKE the dilution concentration as the independent variable, the measured mean value of each dilution concentration as the dependent variable, to calculate the regression equation. CALCULATE the corresponding theoretical value of each dilution concentration point by the regression equation; CALCULATE the absolute or relative percent error between the measured mean value and the theoretical value.
6.4 Instrument comparability
USE a well-condition hematology analyzer to measure a fresh blood sample or a calibrator with traceability; MEASURE 5 times consecutively and calculate the mean value of each parameter. The mean values are used as the target values; CALIBRATE the hematology analyzer with the above-mentioned sample or calibrator. At the end of the calibration, use another fresh blood sample to be measured five times by two difference hematology analyzers; CALCULATE the percent deviation between the mean values of each parameter of the two hematology analyzers.
6.5 Test of accuracy of white blood cell classification for five-classifying analyzers
See Annex A (normative) for the test method.
6.6 Repeatability
TAKE 1 sample within the range specified in Table 2; REPEAT the measurement 10 times according to the conventional method; CALCULATE the coefficient of variation (CV, %) according to Formula (1).
???? ??? ??/???????100 % ... (1)
where.
s - the standard deviation of the measured values of the sample;
???? - the average of the measured values of the sample.
6.7 Carry-over
TAKE the high-value blood samples within the range of Table 4; MEASURE three times and shall provide at least the following information.
a) product name and model;
b) production company?€?s name, registered address, production address and contact; c) number or serial number directly indicated on the label affixed to the instrument; d) power connection conditions, input power.
NOTE. The above information shall be indicated by symbols, if applicable. Any symbols used shall comply with applicable regulations and national standards. If the symbols used do not have existing standards, they shall be described in the relevant documents. 7.3 Instructions
The instruction shall be clear and concise, and the words shall be easy for the user to understand. The instruction shall include at least the following contents. a) product name and model;
b) production company?€?s name, registered address, production address, contact and after-sale service organizations;
c) number of ?€?medical device manufacturing enterprise license?€?, number of medical device registration certificate;
d) product standard number;
e) product performance, main structure, scope of application, principle of detection methods;
f) measurement procedure to be followed when using the analyzer;
g) precautions and other content requiring warnings;
h) interpretation of the graphics, symbols, abbreviations, etc. used by the analyzer labels;
i) installation and use instructions or diagrams (including. product installation instructions and technical drawings, circuit diagrams; the necessary
environmental conditions needed for the correct installation of the product and the technical information to identify the correct installation; other special installation requirements);
j) maintenance and maintenance methods, special storage conditions, methods of the analyzer;
Annex A
(normative)
Five-classifying test method 1)
A.1 Test operation
A.1.1 The reference method must be performed by qualified test personnel in the laboratory.
A.1.2 The instrument must be pre-calibrated and tested with quality control daily. A.1.3 TAKE 20 patient samples, and take two samples from each patient for the tests by the reference method and instrument method.
A.1.4 Research samples shall be uniformly labeled. For example, for the reference method, the blood smears are labeled A, B and standby; for the instrument method, operate according to the instrument operating instructions, the results are labeled C and D.
A.1.5 When using the reference method to carry out five-clas...

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