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YY/T 1621-2018: Medical carbon dioxide incubator
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YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.100
C 44
YY/T 1621-2018
Medical carbon dioxide incubator
Issued on: SEPTEMBER 28, 2018
Implemented on: APRIL 01, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 5
5 Test methods... 8
6 Labels, packaging identification, instructions for use... 10
7 Packaging, transportation, storage... 12
Appendix A (Normative) Test method for temperature control performance... 13
Appendix B (Normative) Test method for carbon dioxide's concentration control
performance... 18
Medical carbon dioxide incubator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels,
packaging identification and instructions for use, packaging, transportation, storage of
medical carbon dioxide incubators (hereinafter referred to as incubators).
This standard is applicable to medical carbon dioxide incubators, for culturing
biological cells, tissues, bacteria and other human-derived samples, in clinical tests. The
upper limit of the incubation temperature of the incubator, to which this standard applies,
is 55 °C; the lower limit of the temperature is 3 °C ~ 5 °C higher than the ambient
temperature; the control range of carbon dioxide concentration is 0% ~ 20%; the
internal volume is 100 L ~ 300 L.
2 Normative references
The following documents are essential for the application of this document. For dated
references, only the dated version applies to this document. For undated references, the
latest edition (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 4793.6 Safety requirements for electrical for measurement control and
laboratory use - Part 6.Particular requirements for laboratory equipment for the
heating of materials
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
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1.General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
4.2.3 The incubator shall have a gas sampling port, to facilitate the measurement of gas
concentration.
4.2.4 The incubator shall be able to be placed stably; it shall be equipped with a level-
adjusting device.
4.3 Temperature display and control performance
4.3.1 The manufacturer shall specify the temperature control range of the incubator.
4.3.2 The temperature display resolution of the incubator shall be 0.1 °C or better.
4.3.3 The temperature display error of the incubator shall be within ±0.2 °C. When the
temperature is set to 37.0 °C, the display error shall be within ±0.1 °C.
4.3.4 The temperature control error of the incubator shall be within ±0.5 °C. When the
temperature is set to 37.0 °C, the control error shall be within ±0.3 °C.
4.3.5 The temperature fluctuation of the incubator shall be within ±0.5 °C. When the
temperature is set to 37.0 °C, the temperature fluctuation shall be within ±0.3 °C.
4.3.6 The temperature uniformity of the incubator shall be within ±1.0 °C. When the
temperature is set to 37.0 °C, the temperature uniformity shall be within ±0.5 °C.
4.4 Carbon dioxide concentration display and control performance
4.4.1 The manufacturer shall specify the carbon dioxide's concentration control range
for the incubator.
4.4.2 The display resolution of carbon dioxide's concentration of the incubator shall be
0.1% or better.
4.4.3 The display error of carbon dioxide's concentration in the incubator shall be within
±0.2%.
4.4.4 The carbon dioxide's concentration control error of the incubator shall be within
±1.0%. When the carbon dioxide's concentration is set to 5.0%, the carbon dioxide's
concentration control error shall be within ±0.5%.
4.5 Relative humidity control performance
If applicable, the relative humidity, inside the incubator, shall not fall below the limit,
which is specified by the manufacturer after stabilization.
4.6 Noise
When the incubator is working normally, the noise shall be ≤ 65 dB(A).
4.7 Alarm
The incubator shall be able to set the temperature and carbon dioxide concentration. It
shall have the following alarm functions.
a) The alarm for the temperature exceeding the upper limit;
b) The alarm for the temperature exceeding the lower limit;
c) The alarm for carbon dioxide concentration exceeding the upper limit;
d) The alarm for carbon dioxide concentration exceeding the lower limit;
e) The alarm for the door opening time exceeding the limit.
4.8 Door open recovery time
4.8.1 Temperature recovery time
The temperature recovery time of the incubator shall be ≤ 10 min.
4.8.2 Carbon dioxide's concentration recovery time
The recovery time of carbon dioxide concentration in the incubator shall be ≤ 10 min.
4.9 Thermal insulation performance
The incubator shall have good thermal insulation performance. The secondary
temperature difference shall be ≤ 8.0 °C.
4.10 Prevention of condensation
The incubator shall control the generation of condensed water. There shall be no
condensed water, on the inside of the inner door, the top, side walls and upper half of
the rear wall of the working room.
Note. The inner door generally refers to the sealed glass door of the incubator.
4.11 Over-temperature protection
In order to prevent the damage to the cultured samples, which are caused by excessive
temperature, the incubator shall have an over-temperature protection function. When
the temperature control device fails, it shall be able to ensure that the temperature of
the incubator does not exceed the set temperature by 1.5 °C.
4.12 Safety
4.12.1 The general requirements for electrical safety of the incubator shall comply with
the provisions of GB 4793.1.
At 1 m from the front, rear, left, right directions of the incubator, use the sound pressure
level A-level weighting network to make measurement; take the maximum value of 4
points, which shall meet the requirements of 4.6.
5.6 Alarm
Carry out inspection of the actual operation, according to the instruction for use, which
is provided by the manufacturer; it shall meet the requirements of 4.7.
5.7 Door open recovery time
5.7.1 Temperature recovery time
According to the test conditions specified in A.1, in the normal working mode of the
incubator, the temperature is set to 37.0 °C; the carbon dioxide's concentration is set to
0.0%.
After the device shows that the temperature reaches the set temperature, wait for 2 hours.
Quickly open all the doors of the incubator; the door opening angle is at least 90°; the
door opening time is 30 s. Start timekeeping, immediately close the door. When the
incubator's temperature recovers to 36.3 °C, stop timekeeping. The time interval meets
the requirements of 4.8.1.
5.7.2 Carbon dioxide concentration's recovery time
According to the test conditions specified in B.1, in the normal working mode of the
incubator, the temperature is set to 37.0 °C; the carbon dioxide's concentration is set to
5.0%.
After the device shows that the temperature reaches the set temperature, wait for 2 hours.
Quickly open all the doors of the incubator; the door opening angle is at least 90°; the
door opening time is 30 s. Start the timekeeping, after the door is quickly closed. When
the carbon dioxide's concentration, at the center of the incubator, returns to 4.5%, stop
timekeeping. The time interval meets the requirements of 4.8.2.
5.8 Thermal insulation performance
According to the test conditions specified in A.1, in the normal working mode of the
incubator, the temperature is set to 37.0 °C; the carbon dioxide's concentration is set to
0.0%.
After the device shows that the temperature reaches the set temperature, wait for 2 hours.
Record the temperature of the incubator. Cut off all heating elements (including
auxiliary heating elements). Keep the incubator running for 1 hour. Record the
temperature of the incubator again. The difference between the two temperature values
is the secondary temperature difference, which shall meet the requirements of 4.9.
5.9 Prevention of condensation
According to the test conditions specified in A.1, in the normal working mode of the
incubator, set the temperature to 37.0 °C; set the carbon dioxide's concentration to 0.0%.
Wait 24 h, after the equipment display temperature reaches the set temperature. Carry
out the visual inspection, which shall meet the requirements of 4.10.
5.10 Over-temperature protection
According to the test conditions specified in A.1, the temperature is set to 37.0 °C; the
carbon dioxide's concentration is set to 0.0%. When the simulated temperature control
device fails, the measurement chamber's temperature shall meet the requirements of
4.11.
5.11 Safety
5.11.1 The general requirements for electrical safety shall be tested, according to the
methods specified in GB 4793.1.
5.11.2 The special requirements for electrical safety shall be tested, according to the
method specified in GB 4793.6.
5.11.3 Electromagnetic compatibility requirements shall be tested, according to the
method specified in GB/T 18268.1.
5.12 Environmental test
Carry out test, according to the provisions of GB/T 14710.
6 Labels, packaging identification, instructions for use
6.1 General
The text content of labels, packaging identifications, instructions for use shall be in
Chinese; other languages may be added. The use of Chinese shall comply with the
national language norm. The words, symbols, graphics, tables, pictures, etc. of labels,
packaging identifications, instructions for use shall be accurate, clear, standardized. The
symbols, which are used in labels and instructions for use, shall comply with the
requirements of YY/T 0466.1.
6.2 Labels
Incubator labels shall contain at least the following.
a) Product name, model or specification;
b) The name and address of the manufacturer;
Appendix B
(Normative)
Test method for carbon dioxide's concentration control performance
B.1 Test conditions
The temperature of the test environment shall be within the range of 22 °C ± 3 °C, to
avoid the influence of heat sources and strong air flow. The interior of the incubator is
in an empty state, BUT accessories, such as shelves, are included. The set temperature
of the incubator is the common temperature point 37.0 °C.
B.2 Test equipment
Carbon dioxide tester is divided into "pump type" and "probe type".
The range of carbon dioxide concentration is 0% ~ 20%; the response time is less than
20 s. The resolution of the carbon dioxide tester shall be better than that of the tested
equipment; the standard gas shall be used for calibration, before use.
Other carbon dioxide concentration measurement methods can be used, as long as they
produce equivalent measurements.
B.3 Arrangement of carbon dioxide detection points
For the "probe type" tester, the sensor shall be placed in the center of the incubator AND
not in direct contact with the shelf. For the "pump type" tester, the sampling tube shall
take sample, from the center of the incubator.
B.4 Setting of test points of carbon dioxide control range
It shall be carried out, under the following concentration detection control points.
a) Detection point for low-point carbon dioxide concentration. In the lower 1/5
position, within the gas concentration range;
b) Detection point for mid-point carbon dioxide concentration. In the middle 1/2
position, within the gas concentration range;
c) Detection point for high-point carbon dioxide concentration. In the high 1/5
position, within the gas concentration range;
d) Detection point for common carbon dioxide concentration. The 5.0% is the
concentration point, which must be tested.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.