YY/T 1621-2018 PDF English
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| YY/T 1621-2018 | 235 | Add to Cart | Auto, 9 seconds. | Medical carbon dioxide incubator | Valid |
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YY/T 1621-2018: Medical carbon dioxide incubator
---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/YYT1621-2018YY 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 incubator1 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 requirements3 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.
