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YY/T 0588-2017 (YYT0588-2017)

YY/T 0588-2017_English: PDF (YYT 0588-2017, YYT0588-2017)
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YY/T 0588-2017English150 Add to Cart 0--9 seconds. Auto-delivery Flow cytometer Valid YY/T 0588-2017

BASIC DATA
Standard ID YY/T 0588-2017 (YY/T0588-2017)
Description (Translated English) Flow cytometer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,190
Date of Issue 2017-12-05
Date of Implementation 2018-12-01
Drafting Organization Beijing Medical Device Inspection Institute, Beckman Coulter Commerce & Trade (China) Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Essen Biologicals (Hangzhou) Co., Ltd.
Administrative Organization National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136)
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration

Standards related to: YY/T 0588-2017

YY/T 0588-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 0588-2005
Flow Cytometer
ISSUED ON. DECEMBER 05, 2017
IMPLEMENTED ON. DECEMBER 01, 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 Technical Requirements ... 7
5 Test Methods ... 9
6 Labels, Marks and Instructions for Use ... 12
7 Package, Transportation and Storage ... 12
Bibliography ... 14
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard was finished through modifying the YY/T 0588-2005 Flow Cytometer;
compared with YY/T 0588-2005, the major technical changes are as follows besides
the editorial modifications.
--- Modify the normative reference documents;
--- Modify the definition of “polity”;
--- Modify the name and requirement of “sensitivity of fluorescence” into “detection
limit of fluorescence”; add the fluorescence detection limit requirement of other
lasers against the corresponding channel fluorescence;
--- Modify the name of “forward scatter sensitivity” into “forward scatter detection
limit”;
--- Modify the requirement of “instrument resolution”; remove the peak width at half
height requirement; specify the requirements of FSC, FITC, PE; other fluorescein
meet the requirements of the manufacturer (see 4.5 instrument resolution
requirements);
--- Modify “surface marker detection accuracy”; add the requirements of CD16/CD56,
and CD19;
--- Modify “surface marker detection repeatability”; perform subsection
requirements against the variation coefficient of CD3, CD4, CD8 positive
percentage results; add the requirements for measuring CD16/CD56 and CD19
(see 4.9 surface marker detection repeatability requirements);
--- Modify the requirements of “carry-over”, which shall be no greater than 0.5%;
--- Delete the “instrument function”;
--- Add security requirement contents of GB 4793.9, YY 0648 (see 4.14 security);
--- Add electromagnetic compatibility requirement contents of GB/T 18268.1, GB/T
18268.26 (see 4.15 electromagnetic compatibility);
--- Modify the test method of “detection limit of fluorescence” (see 5.2 detection limit
of fluorescence);
--- Modify the test method of “fluorescence linearity” (see 5.3 fluorescence linearity);
Flow Cytometer
1 Scope
This Standard specifies the terms and definitions, product classification, technical
requirements, test methods, mark, label and use instructions, package, transportation
and storage of flow cytometer (FCM).
This Standard is applicable to the clinical use of flow cytometer for quantitative analysis
and sorting of single-cell or other non-biological particle membrane surface and the
internal biochemical and biophysical properties (only limited to the flow cytometer with
sorting function).
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191 Packaging – Pictorial Marking for Handling of Goods
GB/T 4793.1 Safety Requirements for Electrical Equipment for Measurement,
Control and Laboratory Use – Part 1. General Requirements
GB/T 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 29791.3 In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 3. In Vitro Diagnostic Instruments for Professional
3.8 Carry-over
The carrying amount of the analyte transferred by the instrument from one test sample
to the next, thereby erroneously cause an increase of the analyte concentration of the
section test sample.
3.9 Standard particle
Microspheres of uniform size and/r labeled with consistent strength, constant
fluorescein for calibration of flow cytometer.
4 Technical Requirements
4.1 Normal working conditions
The normal working conditions of the flow cytometer shall meet the following
requirements.
a) Ambient temperature. as specified in the flow cytometer manual;
b) Relative humidity. as specified in the flow cytometer manual;
c) Power supply voltage. AC 220V±22V; 50Hz±1Hz;
d) Atmospheric pressure. as specified in the flow cytometer manual;
e) Protect from direct expose to the sunlight and avoid heat sources.
4.2 Sensitivity of fluorescence
The sensitivity of fluorescence of flow cytometer shall meet the following requirements.
a) The sensitivity of fluorescence of flow cytometer against the fluorescein
isothiocyanate (FITC) shall be no more than 200 MESF;
b) The sensitivity of fluorescence of flow cytometer against phycoerythrin (PE) shall
be no more than 100 MESF;
c) The sensitivity of fluorescence of flow cytometer against the channel fluorescein
(each laser shall choose at least one fluorescein) of other lasers (such as red
laser, ultraviolet laser, green laser) shall meet the claimed requirements of the
manufacturer.
4.3 Fluorescence linearity
The correlation coefficient (r) of fluorescence intensity linearity of the flow cytometer
less than 10000 pieces of standard particles; perform the histogram analysis on the
test results; obtain the average fluorescence intensity of each peak; according to the
equivalent amount of MESF of each peak provided by the standard particle instructions,
and average fluorescence intensity of each peak obtained by the analysis, take the
common logarithm (Lg value) to perform the linear regression; the antilog of MESF
corresponding to the average fluorescence intensity value at the blank particle position
is the sensitivity of fluorescence.
5.3 Fluorescence linearity
The standard particles are thoroughly mixed, and tested on the machine; collect no
less than 10000 pieces of standard particles; the flow cytometer performs the
histogram analysis on the test results; obtain the average fluorescence intensity of
each peak; according to the equivalent amount of MESF of each peak provided by the
standard particle instructions, and average fluorescence intensity of each peak
obtained by the analysis, calculate the relevant coefficient (r) by the linear regression
between MESF amount (y) and average fluorescence intensity (x).
5.4 FSC sensitivity
The standard particles are thoroughly mixed and tested on the machine; check the
peak signal and standard particle diameter of peak signal displayed on the histogram.
5.5 Instrument resolution
The standard particles are thoroughly mixed and tested on the machine; calculate the
CV value of full peak width of the standard particles in each fluorescent channel; the
results shall meet the requirements of 4.5.
5.6 Resolution of FSC and SSC
5.6.1 Add 5µL of sodium citrate anticoagulated whole blood to the test tube containing
1mL of sheath liquid; mix evenly; test on the machine; check whether the FSC and
SSC spot maps can separate the platelets from the red blood cells.
5.6.2 Take 100µL of EDTA anticoagulated whole blood; after dissolving the red blood
cells, check on the machine; check whether the FSC and SSC spot maps can separate
the three groups (lymphocytes, monocytes, granulocytes) of white blood cells.
5.7 Polity analysis linearity
Use the fluorescently stained standard cell line or standard cell nucleus to test the
average fluorescence intensity of G0/G1 phase and G2/M phase on the machine; then
calculate the ratio of the two average fluorescence intensities.
5.8 Surface marker detection accuracy
...