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YY/T 0588-2017 English PDF (YYT0588-2017)

YY/T 0588-2017 English PDF (YYT0588-2017)

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YY/T 0588-2017: Flow cytometer

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).
YY/T 0588-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE 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 5??L 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 100??L 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

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