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YY 1621-2018: [YY/T 1621-2018] Medical carbon dioxide incubator
YY 1621-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
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.
3.1
Temperature control range
The temperature range, within which the incubator can be effectively controlled,
when operating under specified environmental conditions.
3.2
Working space
The space area within the working room, where the specified technical conditions
are met.
3.3
Chamber temperature
The temperature of the geometric center of the workspace.
4 Requirements
4.1 Working environment conditions
If the manufacturer has no special working environment requirements, the working
environment of the incubator shall meet the following requirements:
a) Ambient temperature: 18 °C ~ 30 °C;
b) Relative humidity: ≤ 80%;
c) Atmospheric pressure: 86 kPa ~ 106 kPa;
d) There is no strong vibration and corrosive gas around;
e) The influence of direct sunlight or other cold and heat sources shall be avoided;
f) Power supply voltage: 220 V ± 22 V;
g) Voltage frequency: 50 Hz ± 1 Hz.
4.2 Appearance and structure
4.2.1 The surface of the incubator shall be clean and flat, without obvious scratches,
burrs and unevenness; the characters and symbols shall be clearly marked.
4.2.2 The internal accessories (such as shelves and supports) of the incubator's working
room shall be easily disassembled and assembled, without tools.
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.
4.12.2 The special requirements for electrical safety of the incubator shall comply with
the provisions of GB 4793.6.
4.12.3 The electromagnetic compatibility requirements of the incubator shall comply
with the provisions of GB/T 18268.1.
4.13 Environmental test
The environmental test of the incubator shall be carried out, in accordance with the
provisions of GB/T 14710.
5 Test methods
5.1 Appearance and structure
Visual observation and actual operation inspection shall meet the requirements of 4.2.
5.2 Temperature display and control performance
5.2.1 Check the technical information provided by the manufacturer, which shall meet
the requirements of 4.3.1.
5.2.2 Visual inspection shall meet the requirements of 4.3.2.
5.2.3 Carry out testing, according to the method in Appendix A; the results shall meet
the requirements of 4.3.3, 4.3.4, 4.3.5, 4.3.6.
5.3 Carbon dioxide's concentration display and control performance
5.3.1 Check the technical information, as provided by the manufacturer, which shall
meet the requirements of 4.4.1.
5.3.2 Visual inspection shall meet the requirements of 4.4.2.
5.3.3 Carry out testing, according to the method in Appendix B; the results shall meet
the requirements of 4.4.3 and 4.4.4.
5.4 Relative humidity control performance
According to the test conditions specified in A.1, the incubator is in normal working
mode: the temperature is set to 37.0 °C, the carbon dioxide's concentration is set to
0.0%. When the humidity detection equipment is placed in the center of the incubator,
its resolution is 0.1% or better. When the device shows that the temperature reaches the
set temperature and waits for 2 h, the humidity, which is measured at the center position,
shall meet the requirements of 4.5.
5.5 Noise
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;
c) The rated power;
d) The power supply voltage and frequency;
e) The date of manufacture and service life.
6.3 Packaging identification
The packing box shall have the following contents:
a) The product model and name;
b) The name of the manufacturer;
c) The net weight and gross weight;
d) The product number and date of manufacture;
e) The overall dimensions;
f) The storage and transportation conditions;
g) The words, diagrams or signs, such as "handle with care", "upward", "afraid of
moisture", "fragile", which are specified in GB/T 191.
6.4 Instructions for use
Instructions for use shall comply with the relevant requirements of national standards
or industry standards. It generally shall include the following contents:
a) The product name, model, specification;
b) The name, registered address, production address, contact information, after-sales
service organization of the manufacturer;
c) The product performance, main structure, scope of application, working space;
d) Precautions and other contents, that need to be warned or prompted;
e) Explanation of graphics, symbols, abbreviations, etc., which are used in medical
device labels;
f) The installation and use instructions or illustrations;
g) The product maintenance and service methods, special storage conditions,
methods;
h) Other contents, which are specified in the product technical requirements, that
shall be indicated in the manual.
Appendix A
(Normative)
Test method for temperature control performance
A.1 Test conditions
The temperature of the test environment shall be within the range of 22 °C ± 3 °C. It
shall avoid the influence of heat sources and strong air flow. The interior of the
incubator is in an empty state, BUT includes internal accessories (such as shelves and
supports).
A.2 Test equipment
The equipment used for temperature detection is generally composed of a temperature
sensor, a temperature recorder or a temperature indicator. The resolution of the
temperature detection equipment shall be better than that of the tested equipment; the
maximum response time of its temperature detection is τ0.9 ≤ 5 s.
A.3 Arrangement of temperature detection points
The distance, between the temperature detection point and the inside of the workspace,
is about 1/10 of the width, height or depth of the workspace. This distance determines
the position of the detection plane. The temperature detection points are evenly
distributed, on the three horizontal detection planes (see Figure A.1). There are 9
detection points, on each detection plane (see Figure A.2), that is, a total of 27 detection
points. The sensor probe of the temperature detection point, on each detection plane,
shall be more than 15 mm away from the shelf, to ensure that the sensor probe does not
come into contact with metal materials, such as the shelf or inner wall.
points of "low, medium, high" are detected, meanwhile one temperature point of "low,
medium, high" is replaced by 37.0 °C.
Example: If the temperature control range of a certain type of incubator is (ambient temperature
+ 5.0 °C) - 55.0 °C, the current test environment temperature is 22.0 °C, THEN, the minimum
control temperature is 22.0 °C + 5.0 °C = 27.0 °C, the maximum control temperature is 55.0 °C,
the low-point temperature detection point is 27.0 °C + (55 °C - 27 °C)/5 = 32.6 °C; the mid-
point temperature detection point is 27.0 °C + (55 °C - 27 °C)/2 = 41.0 °C; high-point
temperature detection point 55.0 °C - (55.0 °C - 27.0 °C)/5 = 49.4 °C.
A.5 Inspection of temperature control performance
The incubator is operating in normal user usage mode, where 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,
before starting recording the data. Take records at the interval of 10 s, for a duration of
1 h. Pay attention to observe the change of temperature display value. Record 10 display
readings randomly.
A.6 Evaluation of temperature performance
According to the temperature data, which is recorded in A.5 "Inspection of temperature
control performance", analyze the temperature data AND evaluate the temperature
control performance.
A.6.1 Calculation of temperature display error
Calculate T display error, according to formula (A.1):
T display error = ±| display - T setting| ………………………… (A.1)
Where:
T display error - The temperature display error;
display - The "arithmetic mean" of the temperature display values, which is
recorded in A.5;
T setting - The temperature set point.
A.6.2 Calculation of temperature control error
Calculate T control error, according to formula (A.2):
Appendix B
(Normative)
Test method for carbon dioxide's concentration control performance
B.1 Test conditions
The temperature of the test environ...