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YY/T 1533-2017

Chinese Standard: 'YY/T 1533-2017'
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BASIC DATA
Standard ID YY/T 1533-2017 (YY/T1533-2017)
Description (Translated English) Automatic time-resolved fluorescence counter
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,860
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Drafting Organization Beijing Medical Device Inspection Institute, Suzhou New Wave Biological Technology Co., Ltd., Shenzhen Ai Kang Biological Technology 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 1533-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Automatic time-resolved fluorescence counter
全自动时间分辨荧光免疫分析仪
ISSUED ON: MARCH 28, 2017
IMPLEMENTED ON: APRIL 01, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Requirements ... 5 
4 Test method ... 6 
5 Markings, labels, user instructions ... 11 
6 Packaging, transportation, storage ... 11 
References ... 12 
Automatic time-resolved fluorescence counter
1 Scope
This standard specifies the requirements, test methods, markings, labels, and
instructions for use, packaging, transportation, storage of automatic time-
resolved fluorescence counter (hereinafter referred to as analyzers).
This standard applies to automatic time-resolved fluorescence counter.
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 standard.
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
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 use
YY 0648 Safety requirements for electrical equipment for measurement
control and laboratory use - Part 2-101: Particular requirements for in vitro
If pipetting volume of ≥ 10 µL and < 50 µL, the relative deviation of loading
accuracy is ≤ ±5%; if pipetting volume of ≥ 50 µL, the relative deviation of
loading accuracy is ≤ ±3%.
3.3.2 Precision of sample loading
If pipetting volume of ≥ 10 µL and < 50 µL, the precision of sample loading CV
is ≤ 5%. If pipetting volume of ≥ 50 µL, the precision of sample loading CV is <
2%.
3.3.3 Contamination by sample loading needle
Carrying contamination rate is < 0.01%.
3.3.4 Residual amount of lotion
The residual amount of lotion is < 3 μL/hole.
3.4 Temperature accuracy and fluctuation
The temperature accuracy of the incubation chamber is within ±1.5 °C. The
temperature fluctuation is within ±1.5 °C.
3.5 Repeatability of clinical test
The in-batch repeatability CV of the kit is ≤ 15%.
3.6 Environmental test requirements
It shall meet the requirements of the applicable clauses in GB/T 14710.
3.7 Electrical safety requirements
It shall meet the requirements of the applicable clauses in GB 4793.1, GB
4793.9, YY 0648.
3.8 Electromagnetic compatibility requirements
It shall meet the requirements of the applicable clauses of GB/T 18268.1 and
GB/T 18268.26.
4 Test method
4.1 Appearance
Visual inspection with normal vision or corrected vision under natural light shall
meet the requirements of 3.1.
error of 10-10 mol/L europium standard solution.
4.2.5 Stability
After the analyzer is turned on and in a stable working state, take one set of
200 μL 10-10 mol/L europium standard solution to repeat the test 10 times.
Calculate the average value of the measurement results. Then re-start the
machine after 4 h and 8 h to repeat the test 10 times; calculate the average
value of the measurement result. Take the first measurement result as the
reference value; calculate the relative offset (α, %) according to formula (2),
which shall meet the requirements of 3.2.5.
Wherein:
- The average of the measured values in the 4th and 8th hours;
- The average value of the initial measured value.
4.3 Sample loading and cleaning system
4.3.1 Sample loading accuracy
The following methods can be used for verification:
a) Take 12 clean microwell cups; use a calibrated analytical balance
(accuracy is ±0.1 mg) to weigh each empty cup; record it as W0i (where i
= 1, …, 12);
b) Put the weighed empty cups into the first row of flat-bottomed microplates
in turn; add 100 μL of 0.9% saline to the first row of micro-bottomed cups
of flat-bottomed microplates; weigh each microwell cup and record it as
W1i (where i = 1,…, 12);
c) Calculate the result of (W1i - W0i) and convert it to volume, which is the
sample loading volume per hole;
d) Calculate the relative deviation between the actual sample loading volume
per hole and the set sample loading volume, which is the sample addition
accuracy and shall meet the requirements of 3.3.1.
Note: It can also be verified according to the test method provided by the
manufacturer.
formula (3) and shall meet the requirements of 3.3.3.
Wherein:
c - Concentration value of high concentration sample.
4.3.4 Residual volume of lotion
The following methods can be used for verification:
a) Take a clean microplate and use a calibrated ten-thousandth balance to
weight it; record it as M1;
b) Put the weighed microplate on any path of plate washing platform; run the
plate washing twice; soak it for 2 s;
c) Weigh the microplate after washing the plate and record it as M2;
d) Calculate the average value of the residual volume of each hole; convert
it into volume, which is the residual volume of the washing solution and
shall meet the requirements of 3.3.4.
4.4 Temperature accuracy and fluctuation
The following methods can be used for verification:
a) Put the temperature sensor probe of the thermometer (accuracy 0.1 °C)
into any incubation chamber;
b) Set the temper......
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