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YY/T 0653-2017 (YYT 0653-2017)

YY/T 0653-2017_English: PDF (YYT0653-2017)
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BASIC DATA
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Older Standard (superseded by this standard) YY/T 0653-2008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

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.