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YY 1621-2018: [YY/T 1621-2018] Medical carbon dioxide incubator
YY 1621-2018
Medical carbon dioxide incubator
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Medical carbon dioxide incubator
Released on.2018-09-28
2020-04-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 1
5 Test method 3
6 Labels, packaging identification and instructions for use5
7 Packaging, transport and storage 6
Appendix A (Normative Appendix) Temperature Control Performance Test Method 7
Appendix B (Normative Appendix) Carbon Dioxide Concentration Control Performance Test Method 10
Medical carbon dioxide incubator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels, packaging labels of medical carbon dioxide incubators (hereinafter referred to as incubators).
Instructions for use, packaging, transportation and storage.
This standard is applicable to medical carbon dioxide incubators for culturing biological cells, tissues, bacteria and other human-derived samples in clinical tests. Book
The upper limit of the cultivation temperature of the standard incubator is 55°C, the lower limit of the temperature is 3°C to 5°C higher than the ambient temperature, and the carbon dioxide concentration is controlled.
The range is 0%~20%, and the internal volume is 100L~300L.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
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 Equipment for Measurement, Control and Laboratory Use Part 6.Characteristics of Laboratory Material Heating Equipment
special requirements
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
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 studio 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℃~30℃;
b) Relative humidity. ≤80%;
c) Atmospheric pressure. 86kPa~106kPa;
d) There is no strong vibration and corrosive gas around;
e) The influence of direct sunlight or other cold and heat sources should be avoided;
f) Power supply voltage. 220V±22V;
g) Voltage frequency. 50Hz±1Hz.
4.2 Appearance and structure
4.2.1 The surface of the incubator should be clean and flat, without obvious scratches, burrs and unevenness, and the characters and symbols should be clearly marked.
4.2.2 The internal accessories (such as shelves and supports) of the incubator studio should be easily disassembled and assembled without tools.
4.2.3 The incubator shall have a gas sampling port to facilitate the measurement of gas concentration.
4.2.4 The incubator should be able to be placed stably, and should 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 should be 0.1°C or better.
4.3.3 The temperature display error of the incubator should be within ±0.2°C. When the temperature is set to 37.0°C, the display error should be within ±0.1°C.
between.
4.3.4 The temperature control error of the incubator should be within ±0.5°C. When the temperature is set to 37.0°C, the control error should be within ±0.3°C.
between.
4.3.5 The temperature fluctuation of the incubator should be within ±0.5℃, when the temperature is set to 37.0℃, the temperature fluctuation should be within ±0.3℃
between.
4.3.6 The temperature uniformity of the incubator should be within ±1.0°C. When the temperature is set to 37.0°C, the temperature uniformity should be within ±0.5°C.
between.
4.4 Carbon dioxide concentration display and control performance
4.4.1 The manufacturer shall specify the carbon dioxide concentration control range for the incubator.
4.4.2 The carbon dioxide concentration of the incubator should show a resolution of 0.1% or better.
4.4.3 The display error of carbon dioxide concentration in the incubator should be within ±0.2%.
4.4.4 The carbon dioxide concentration control error of the incubator should be within ±1.0%. When the carbon dioxide concentration is set to 5.0%, the carbon dioxide concentration
The degree of control error should be within ±0.5%.
4.5 Relative Humidity Control Performance
If applicable, the relative humidity inside the incubator shall not fall below the limit specified by the manufacturer after stabilization.
4.6 Noise
When the incubator is working normally, the noise should be ≤65dB(A).
4.7 Alarm
The incubator should be able to set the temperature and carbon dioxide concentration, and should have the following alarm functions.
a) The temperature exceeds the upper limit alarm;
b) Alarm when the temperature exceeds the lower limit;
c) The carbon dioxide concentration exceeds the upper limit alarm;
d) The carbon dioxide concentration exceeds the lower limit alarm;
e) Alarm when the door opening time exceeds the limit.
4.8 Door open recovery time
4.8.1 Temperature recovery time
The temperature recovery time of the incubator should be ≤10min.
4.8.2 Carbon dioxide concentration recovery time
The recovery time of carbon dioxide concentration in the incubator should be ≤10min.
4.9 Thermal insulation performance
The incubator should have good thermal insulation performance, and the secondary temperature difference should be ≤8.0℃.
4.10 Prevent the generation of condensation water
The incubator should control the generation of condensed water, and there should be no condensed water on the inside of the inner door and the top, side walls and upper half of the rear wall of the working chamber.
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 caused by excessive temperature, the incubator should have the function of over-temperature protection. When the temperature control device fails, it should be able to protect the
The temperature of the certificate box should not exceed the set temperature by 1.5°C.
4.12 Security
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 Test according to the method in Appendix A, the results should meet the requirements of 4.3.3, 4.3.4, 4.3.5 and 4.3.6.
5.3 Carbon dioxide concentration display and control performance
5.3.1 Check the technical information 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 Test according to the method in Appendix B, the results should 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, in the normal working mode of the incubator, the temperature is set to 37.0 ℃, and the carbon dioxide concentration is set to
0.0%, place the humidity detection device in the center of the incubator, and its resolution is 0.1% or better, when the device shows that the temperature reaches the set temperature
After waiting for 2h, the humidity measured at the central position should meet the requirements of 4.5.
5.5 Noise
At a distance of 1m from the front, rear, left, and right directions of the incubator, use the sound pressure level A-level weighting network to measure, and take the maximum value of the four points.
In accordance with the provisions of 4.6.
5.6 Alarm
According to the actual operation inspection provided by the manufacturer's instructions for use, it should 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 ℃, and the carbon dioxide concentration is set to
0.0%.
Wait 2 hours after the device shows that the temperature reaches the set temperature, and quickly open all the doors of the incubator, the door opening angle is at least 90°, and the door opening time
30s, start timing after closing the door quickly, stop timing when the temperature of the incubator returns to 36.3 °C, and the time interval meets the requirements of 4.8.1.
5.7.2 Carbon dioxide concentration 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 ℃, and the carbon dioxide concentration is set to
5.0%.
Wait 2 hours after the device shows that the temperature reaches the set temperature, and quickly open all the doors of the incubator, the door opening angle is at least 90°, and the door opening time
30s, start timing after closing the door quickly, stop timing when the carbon dioxide concentration value at the center of the incubator returns to 4.5%, and the time interval
Meet 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 ℃, and the carbon dioxide concentration is set to
0.0%.
Wait 2 hours after the device shows that the temperature reaches the set temperature, record the temperature of the incubator, and cut off all heating elements (including auxiliary heating elements).
Items), keep the incubator running for 1h, and record the temperature of the incubator again. The difference between the two temperature values is the second temperature difference, which should 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, the temperature is set to 37.0 ℃, and the carbon dioxide concentration is set to
0.0%. Wait 24h after the equipment display temperature reaches the set temperature, and the visual inspection should 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 concentration is set to 0.0%, and the simulated temperature control device fails.
The temperature of the measuring chamber shall meet the requirements of 4.11.
5.11 Safety
5.11.1 The general requirements for electrical safety shall be inspected according to the methods specified in GB 4793.1.
5.11.2 The special requirements for electrical safety shall be inspected according to the methods 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
The inspection shall be carried out according to the provisions of GB/T 14710.
6 Labels, packaging identification and instructions for use
6.1 General
The text content of labels, packaging signs and instructions for use shall be in Chinese, and other languages may be added. The use of Chinese should be in accordance with the national
Common language specification. The text, symbols, graphics, tables, pictures, etc. of labels, packaging signs and instructions for use shall be accurate, clear, and compliant.
Fan. The symbols used in labels and instructions for use shall comply with the requirements of YY/T 0466.1.
6.2 Labels
Incubator labels should contain at least the following.
a) product name, model or specification;
b) the name and address of the manufacturer;
c) rated power;
d) Power supply voltage and frequency;
e) Date of manufacture and expiry date.
6.3 Packaging Identification
The packing box should have the following contents.
a) product model and name;
b) the name of the manufacturer;
c) net weight and gross weight;
d) product number and date of manufacture;
e) overall dimensions;
f) Storage and transportation conditions;
g) According to the words, diagrams or signs specified in GB/T 191, such as "handle with care", "upward", "afraid of moisture" and "fragile".
6.4 Instructions for use
Instructions for use shall comply with the relevant requirements of national standards or industry standards, and generally shall include the following contents.
a) Product name, model and specification;
b) The name, registered address, production address, contact information and after-sales service unit of the manufacturer;
c) Product performance, main structure, scope of application, working space; ...