YY/T 1582-2018 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1582-2018 | English | 230 |
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Colloidal gold immunochromatography reader
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YY/T 1582-2018: Colloidal gold immunochromatography reader---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1582-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.100
C 44
Colloidal gold immunochromatography reader
Issued on. FEBRUARY 24, 2018
Implemented on. MARCH 01, 2019
Issued by. State Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Requirements... 5
4 Test method... 7
5 Labels and instructions for use... 11
6 Packaging, transportation and storage... 12
Appendix A (Informative) Preparation and measurement calibration method of
quality control strip... 14
References... 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The
issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard shall be under the jurisdiction of the National Medical Clinical
Laboratory and In Vitro Diagnostic System Standardization Technical
Committee (SAC/TC 136).
Drafting organizations of this standard. Beijing Medical Device Technology
Review Center, Beijing Medical Device Inspection Institute, Beijing Lepu
Medical Technology Co., Ltd., Institute of Optics and Laser Metrology of
Chinese Academy of Metrology.
The main drafters of this standard. Jiang Yan, Yan Juan, Chen Yongqiang, Lv
Liang.
Colloidal gold immunochromatography reader
1 Scope
This standard specifies the requirements, test methods, labels and instructions
for use, packaging, transportation and storage of colloidal gold
immunochromatography analyzers.
This standard is applicable to instruments that interpret the results of samples
by measuring the reflectivity of the bands in the reaction zone of the colloidal
gold reagent card (hereinafter referred to as analyzers).
This standard does not apply to instruments that use fluorescent labels or other
labeling methods for rapid immunoassay.
2 Normative references
The following documents are indispensable for the application of this document.
For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies
to this document.
GB/T 191 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 4793.9 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
3 Requirements
3.1 Appearance
The following requirements shall be met when applicable.
3.2 Resolution
It may choose one of the following methods.
3.3 Accuracy
According to the following priority order, one of the following methods can be
selected.
3.4 Repeatability
It may choose one of the following methods.
3.5 Linearity
It may choose one of the following methods.
3.6 Channel consistency (if applicable)
Test the quality control strip, the relative range (Rp) of the measurement results
of each channel shall not be greater than 5%.
3.7 Stability
Test the quality control strip, the relative range (R) shall not exceed 5%.
3.8 Function
At least the following functions shall be included; the enterprise shall also
determine other functions according to the characteristics of the product.
3.9 Safety requirements
It shall meet the requirements of applicable clauses in GB 4793.1, GB 4793.9,
YY 0648.
4 Test method
4.1 Normal working conditions
4.1.1 Power supply voltage. AC 220 V; frequency. 50 Hz.
4.1.2 Ambient temperature. 10 °C ~ 30 °C.
4.1.5 The reflectivity of the quality control strip used in the test methods of 4.3,
4.4, 4.5, 4.6, 4.7 shall be traceable with reference to the method described in
Appendix A; the preparation and assignment methods shall be clearly defined.
4.2 Appearance
Visual inspection with normal vision or corrected vision under natural light shall
meet the requirements of 3.1.
4.3 Resolution
4.4 Accuracy
4.4.1 Relative deviation
Use matching reagents to test certified reference materials. The measured
value is recorded as (Xi). Use the formula (1) to respectively calculate the
relative deviation B. If the three measurement results meet the requirements of
3.3a), it is deemed qualified. If more than or equal to 2 measurement results do
not meet, it is judged as unqualified. If one measurement does not meet the
requirements, it shall make 20 tests continuously again; use the formula (1) to
calculate the relative deviation. If greater than or equal to 19 measurement
results meet the requirements of 3.3a), it is judged as qualified.
4.5 Repeatability
4.5.1 Test quality control strip
Test the 3 quality control strips with high, medium and low reflectivity in the
reflectivity range of [0.20, 0.80]; repeat the measurement 10 times; calculate
the average (M) and standard deviation (SD) of the 10 measurement results;
calculate the coefficient of variation (CV) according to formula (2), which shall
meet the requirements of 3.4a).
4.6 Linearity
4.6.1 Test quality control strip
Test at least 5 quality control strips with evenly distributed reflectivity in [0.20,
0.80]; each quality control strip is tested 3 times; use the formula (3) to calculate
the correlation coefficient (r) of linear regression, which shall meet the
requirements of 3.5a).
4.7 Channel consistency (if applicable)
Test the quality control strip which has a reflectivity range of [0.30, 0.40];
measure the same quality control strip 3 times for each channel. Calculate the
arithmetic average () and total average () of the measured values of each
channel. Use formula (4) to calculate the relative range (Rp) of the
measurement results of each channel, which shall meet the requirements of 3.6.
4.8 Stability
Test the quality control strip which has a reflectivity signal value within the
measurement range of the instrument.
4.9 Function
Perform verification in accordance with the instructions and it shall meet the
requirements of 3.8.
4.10 Safety requirements
Perform test according to the method specified in GB 4793.1, GB 4793.9, YY
0648, the results shall meet the requirements of 3.9.
4.11 Electromagnetic compatibility
Perform test according to the method specified in GB/T 18268.1 and GB/T
18268.26, the results shall meet the requirements of 3.10.
4.12 Environmental test
Perform test according to the method specified in GB/T 14710, the results shall
meet the requirements of 3.11.
5 Labels and instructions for use
5.1 General
It shall meet the requirements of GB/T 29791.3.
5.2 Label
The analyzer's label shall be clearly attached in a prominent position and
provide at least the following information.
5.3 Instruction manual
The instruction manual shall meet the requirements of the Provisions on the
Administration of Medical Device Instructions and Labels; it shall at least
include the following.
6 Packaging, transportation and storage
6.1 Packaging
The packaging shall meet the following requirements.
6.2 Transportation
Transport in accordance with the requirements set by the manufacturer.
6.3 Storage
Store it in accordance with the requirements specified by the manufacturer.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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