YY/T 0653-2017_English: PDF (YY/T0653-2017)
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| Standard ID | YY/T 0653-2017 (YY/T0653-2017) | | Description (Translated English) | Hematology analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 14,132 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY/T 0653-2008 | | Drafting Organization | Chinese People's Liberation Army General Hospital, Beijing Medical Device Inspection Institute, Sysmex Medical Electronics (Shanghai) Co., Ltd., Changchun Dirui Medical Technology Co., Ltd., Horiba (China) Trading Co., Ltd., Shenzhen Mindray Biomedical Co., Ltd., Beckman Coulter Commerce (China) Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Standard ID | YY/T 0653-2008 (YY/T0653-2008) | | Description (Translated English) | Hematology analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 12,171 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Quoted Standard | GB/T 191-2008; GB 4793.1; GB/T 14710; YY 0466-2003 | | Drafting Organization | Sysmex Medical Electronics (Shanghai) Co., Ltd. | | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | | Regulation (derived from) | SFDA [2008] No. 192 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the hematology analyzer terms and definitions, classification, requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to visible components of human blood for qualitative and quantitative analysis, and provide relevant information hematology analyzer (hereinafter referred to as the analyzer). This standard does not apply to the reticulocyte analyzer. |
YY/T 0653-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 0653-2008
Hematology analyzer
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Product classification ... 7
5 Technical requirements ... 7
6 Test methods ... 11
7 Labels, marks and instructions for use ... 14
8 Packaging, transport and storage ... 14
Annex A (normative) Five classification test method ... 15
Bibliography ... 18
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
The revision of this Standard is based on YY/T 0653-2008. Compared with YY/T
0653-2008, in addition to the editorial modifications, the main changes in this
Standard are as follows.
- modified the application scope of this Standard, changed it as "this
Standard is applicable to the hematology analyzer that analyzes physical
components in human blood and provides relative information" (see
Clause 1);
- the description in normative references is based on GB/T 1.1-2009;
- for undated reference documents, the latest versions apply to this Standard;
- the terms and definitions of accuracy, precision, linearity, carryover shall
refer to the general term definitions listed in GB/T 29791.1 (see Clause 3);
- modified the definition of hematology analyzer in the terms and definitions,
specified that it is used for the detection of human blood sample (see
Clause 3);
- modified the description in the product classification, modified 4.1 as
"analyzer with only blood cell count function", "two-group" in 4.2 as
"dichotomous", deleted all "semi-automatic, fully automatic" (see Clause
4);
- modified the provisions on atmospheric pressure in normal working
conditions as "86.0kPa ~ 106.0kPa", added a NOTE. If the conditions in
5.1.1~5.1.4 are inconsistent with the conditions stated in the manufacturer
mark, the conditions specified in the product shall prevail (see 5.1);
- modified the linearity, modified "linear deviation" as "allowed deviation
range", added the requirements for linear correlation coefficient, modified
HGB linear range (see 5.3);
- modified instrument comparability to accuracy, used fixed value fresh blood
for testing (see 5.4, 6.5);
- modified the reference range of normal blood WBC, RBC, HGB, PLT, HCT
or MCV in precision (see 5.5.1, 5.61);
- modified the accuracy test of five-classification analyzer white blood cell
classification (see 5.6.2);
Hematology analyzer
1 Scope
This Standard specifies the terms and definitions, product classification,
technical requirements, test methods, labels, marks and instructions for use,
packaging, transport and storage of hematology analyzer.
This Standard is applicable to the hematology analyzer that analyzes physical
components in human blood and provides relative information (hereinafter
referred to as the analyzer).
This Standard is NOT applicable to the reticulocyte testing.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 191, Packaging and storage marks
GB 4793.1, Safety requirements for 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. Particular requirements for automatic and
semi-automatic laboratory equipment for analysis and other purposes
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
GB/T 29791.1, In vitro diagnostic medical devices - Information supplied by
the manufacturer(labelling) - Part 1. Terms, definitions and general
requirements
an ability that gives the measured magnitude directly proportional to the
measured value in the sample
[GB/T 29791.1-2013, Definition A.3.21]
3.7 carryover
introduction of materials not belonging to it in the reaction mixture
[GB/T 29791.1-2013, Definition A.3.8]
4 Product classification
4.1 Analyzer with only blood cell count function.
4.2 Dichotomous blood analyzer. an analyzer capable of dividing white blood
cells into large and small - dichotomous cells.
4.3 Triad blood analyzer. an analyzer capable of dividing white blood cells into
large, medium, and small - triad cells.
4.4 Five-classification blood analyzer. an analyzer capable of dividing white
blood cells into five types (neutrophils, lymphocytes, monocytes, eosinophils,
basophils).
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. If the conditions in 5.1.1~5.1.4 are inconsistent with the conditions stated in the
manufacturer mark, the conditions specified in the product shall prevail.
5.2 Blank count
The blank count of the analyzer shall meet the requirements of Table 1.
5.9 Safety
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, GB/T
18268.26.
6 Test methods
6.1 Test conditions
The test conditions shall meet the following requirements.
a) shall meet the normal working conditions specified in 5.1;
b) use reagents, quality control products and products for calibration
recognized by the manufacturer; the products for calibration shall be
traceable;
c) use the manufacturer's recommended sample anticoagulation method;
d) the analyzer shall reach a steady state before the test.
6.2 Blank count
Use dilution solution as sample to perform the test 3 times continuously on the
analyzer. Take the maximum value of three test results.
6.3 Linearity
6.3.1 Use linearity quality control products
Operate according to the instructions for use of linearity quality control products.
And calculate the linear deviation and relative linearity coefficients.
6.3.2 Use High value sample
Take anticoagulated whole blood, centrifuge to remove plasma, make it into
concentrated blood cells. Perform gradient dilution with own platelet-poor
plasma/diluent for concentrated blood cells. Dilute at least 5 concentrations so
that the high concentration value is close to the upper limit of the linear range,
6.9 Basic functions of analyzer
Verify by inspection.
6.10 Appearance
Perform visual inspection with normal or corrected vision under natural light.
6.11 Safety
The safety test method shall comply with the requirements of the applicable
provisions of GB 4793.1, GB 4793.9 and YY 0648.
6.12 Environment
The environmental test method shall comply with the requirements of the
applicable provisions of GB/T 14710.
6.13 Electromagnetic compatibility
The electromagnetic compatibility test method shall comply with the
requirements of the applicable provisions of GB/T 18268.1 and GB/T 18268.26.
7 Labels, marks and instructions for use
In accordance with the provisions of GB/T 29791.3.
8 Packaging, transport and storage
8.1 Packaging
Analyzer packaging shall meet the following requirements.
a) the pictorial marks used in packaging shall comply with the provisions of
GB/T 191;
b) the packaging shall protect the analyzer from natural and mechanical
damage;
c) the instructions for use shall be included in the box.
8.2 Transport
Transport shall be according to manufacturer's specifications.
8.3 Storage
Storage shall be in accordance with manufacturer's specifications.
......
YY/T 0653-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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).
ܥܸ ൌ ݏ/̅ݔൈ100 % ... (1)
where.
s - the standard deviation of the measured values of the sample;
̅ݔ - 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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