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YY 0677-2008: [YY/T 0677-2008] Liquid nitrogen cryosurgical equipment
YY 0677-2008
Liquid nitrogen cryosurgical equipment
ICS 11.040.60
C37
People's Republic of China Pharmaceutical Industry Standard
Liquid nitrogen cryosurgery treatment equipment
2008-10-17 released
Implementation of.2010-06-01
Issued by the State Food and Drug Administration
Preface
This standard is in accordance with GB 9706.1 "Medical Electrical Equipment Part 1.General Requirements for Safety" and GB/T 14710-1993 "Medical Electrical Equipment"
Equipment Environmental Requirements and Test Methods" to be used together.
This standard was proposed and managed by the Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
Drafting organizations of this section. Zhejiang Medical Device Research Institute, Zhejiang Medical Device Inspection Institute.
The main drafters of this standard. Lu Weimin, Yin Jianbing, Tang Li, Sun Yu, Zhang Zhongmin, Ma Li.
Liquid nitrogen cryosurgery treatment equipment
1 scope
This standard specifies the scope, definition and terminology, requirements, test methods, inspection rules and signs, labels,
Packaging and other requirements.
This standard applies to cryosurgery where the refrigerant is liquid nitrogen, the latent heat of vaporization phase change is used for refrigeration, and the liquid nitrogen storage capacity is greater than 1L.
Treatment equipment (hereinafter referred to as treatment equipment). The treatment equipment mainly produces low temperature on the target tissue, which is used for cryo-necrosis, cryo-block, inflammatory reaction and
For freezing adhesion.
2 Normative references
The clauses in the following documents become clauses of this standard after being quoted in this standard. For dated reference documents, all subsequent
Amendments (not including errata content) or revisions do not apply to this standard. However, all parties that have reached an agreement based on this standard are encouraged to study
Is the latest version of these files available? For undated references, the latest version is applicable to this standard.
GB 9706.1 Medical electrical equipment Part 1.General requirements for safety (GB 9706.1-2007, IEC 60601-1.1988,
IDT)
GB/T 14710-1993 Environmental requirements and test methods for medical electrical equipment
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing (GB/T 16886.1-2001,
idt ISO 10993-1..1997)
YY 0466-2003 Medical devices are used for medical device labeling, marking and providing information symbols (YY 0466-2003,
ISO 15223.2000, IDT)
YY 0678 Performance and safety of medical cryosurgery equipment
Regulations on the Administration of Medical Device Instructions, Packaging Marks and Labels, Order No. 10 of the State Food and Drug Administration
3 Terms and definitions
The following terms and definitions established by YY 0678 apply to this standard.
3.1
The heat absorbed when a liquid turns into a gas.
3.2
Pipeline for conveying liquid nitrogen.
3.3
The container for storing liquid nitrogen in the treatment equipment.
3.4
The cryotherapy probe that is in contact with the tissues in the human body.
3.5
A device specially designed to deliver liquid nitrogen directly to the target tissue.
3.6
Hollow, closed at the end, usually its shape conforms to a specific anatomical part, and liquid nitrogen passes through the outer surface of the end to freeze the target tissue.
3.7
The cooling process of the target tissue of the body.
3.8
The solenoid valve in the equipment that works at low temperature is used to control the transmission of liquid nitrogen.
4 requirements
4.1 Working environment
Normal working conditions of treatment equipment.
Ambient temperature. -5℃～40℃;
Atmospheric pressure. 86kPa～106kPa;
Working voltage. AC 220V, 50Hz.
4.2 Composition of treatment equipment
The treatment equipment is mainly composed of liquid nitrogen storage, liquid nitrogen delivery pipe, freezing probe, pressure gauge, low temperature solenoid valve and temperature control equipment.
4.3 Appearance of treatment equipment
4.3.1 The outer surface of the liquid nitrogen storage device of the treatment equipment should be smooth and clean, with uniform solder joints, and no burrs and other defects.
4.3.2 The surface of the freezing probe should be smooth and free of burrs, flashes, barbs, etc.
4.3.3 The control panel of the treatment equipment should be smooth with clear readings.
4.3.4 The surface of the liquid nitrogen delivery pipe should be smooth.
4.4 The sealing performance of treatment equipment (for self-pressurized liquid nitrogen storage)
4.4.1 After the liquid nitrogen storage of the main unit of the treatment device is sealed, the air leakage rate of the treatment device within 1 hour when the working pressure is greater than the standard atmospheric pressure
Should not be more than 5%.
4.4.2 There should be no leakage at the connection of each connection pipeline of the treatment equipment.
4.5 Work performance index
4.5.1 Working pressure of liquid nitrogen storage (for self-pressurized liquid nitrogen storage)
The working pressure indicated by the liquid nitrogen storage should be reached within 10 minutes of starting up.
4.5.2 Operating temperature adjustment range
The temperature indicating regulator of the treatment equipment has an indication range of -200°C to 40°C, which can instantly display the operating temperature of the cryogenic probe in the freezing zone.
Temperature, and should have temperature setting and adjustment functions within this temperature range.
4.5.3 Working noise
When the treatment equipment is in normal operation, the working noise should not exceed 62dB (A weighting).
4.5.4 Liquid nitrogen delivery pipe
When using, it should be light and flexible; when the main engine is working, the delivery pipe should be able to transport liquid nitrogen reliably, and there should be continuous liquid at the outlet end within 2 min.
Nitrogen output.
4.5.5 Temperature control of freezing probe
When the probe is working or unloaded, the freezing zone of the probe should be able to reach the set temperature within the preset time, and the error is below -100°C
It does not exceed 10℃, and it does not exceed 5℃ when it is above -100℃.
4.5.6 Thermometer accuracy
The thermometer used to display the working temperature of the freezing probe should be able to accurately reflect the temperature change of the freezing probe in time, and the error should not exceed
Over 3°C.
4.5.7 Low temperature solenoid valve
The low-temperature solenoid valve that controls the output of liquid nitrogen in the treatment equipment opens and closes flexibly and reliably, without freezing.
4.5.8 Overpressure release device
When the pressure of the liquid nitrogen storage of the treatment equipment exceeds 1.1 times the maximum working pressure, there should be an overpressure release device to instantly release the overpressure.
4.5.9 Freezing probe temperature
In the working state, the frozen probe should be well insulated. When the probe is exposed to the air to work, the connecting part of the probe should be in the direction of the probe.
There should be no frost or condensation in less than 2/3 places.
4.6 Alarm function
4.6.1 Sound of alarm signal
The alarm sound pressure level of the treatment equipment is not less than 65dB (A weighting).
4.6.2 Pressure alarm (using pressure control method)
When the equipment is working normally, when the pressure in the liquid nitrogen storage exceeds the normal working pressure range, the alarm device should give an alarm.
4.6.3 Liquid level alarm
When the equipment is working normally, the alarm device should give an alarm when the liquid level in the liquid nitrogen storage is lower than the normal working range.
4.7 Electrical safety performance of treatment equipment
The electrical safety performance of the treatment equipment should meet the requirements of GB 9706.1 and YY 0678.
4.8 Environmental test of treatment equipment
The environmental test grouping and project requirements of treatment equipment are specified by the manufacturer in accordance with the GB/T 14710-1993 standard.
4.9 The biological performance of the treatment device probe
Biological evaluation should be carried out in accordance with the provisions of GB/T 168886.1.
5 Test method
5.1 Appearance
Hand visual inspection should meet the requirements of 4.3.
5.2 Tightness test
5.2.1 Leakage test of liquid nitrogen storage
The test is carried out in an environment of 25℃±2℃.
Connect the equipment correctly and put it in the standby state, connect the pressure device and ensure the seal, remove the overpressure relief device or make it
Work, the switch that controls the output of liquid nitrogen should be adjusted to the off state.
Turn on the pressurizing device until the pressure gauge shows that the pressure in the liquid nitrogen storage reaches 2 times the maximum working pressure of the equipment. Close the pressurizing device and
Record the pressure gauge reading P1.
After the equipment is allowed to stand for 1 hour, observe the pressure gauge reading again and record P2.Compare P1 and P2, repeat the above process twice, should meet 4.4.1
Claim.
5.2.2 Tightness test of connecting pipeline
The test is carried out in an environment of 25℃±2℃.
Connect the equipment correctly and put it in the standby state, connect the pressure device and ensure the seal, remove the overpressure relief device or make it
Work, use the sealing device to make the outlet end of the equipment liquid nitrogen delivery pipeline in a sealed state, and adjust the liquid nitrogen output switch to the open state.
Turn on the pressurizing device until the pressure gauge shows that the pressure in the liquid nitrogen storage reaches the maximum working pressure of the equipment. Turn off the pressure device and record
The pressure gauge reads P1.
After the equipment is allowed to stand for 1 hour, observe the pressure gauge reading again and record P2.Compare P1 and P2, repeat the above process twice, should meet 4.4.2
Requirements.
5.3 Performance index test
5.3.1 Working pressure test of liquid nitrogen storage
The treatment equipment is energized and heated for 10min observation, and it should meet the requirements of 4.5.1.
To make the treatment equipment in a normal working state, the actual temperature adjustment should meet the requirements of 4.5.2.
5.3.3 Working noise test
When the treatment equipment is working normally, place the sound level meter at 1m away from the treatment equipment, and use the sound level meter A weighting network to measure the front, back, left and right
The sound pressure level in the four directions, whichever is the maximum, shall meet the requirements of 4.5.3.
5.3.4 Liquid nitrogen delivery pipe test
The actual operation of the liquid nitrogen delivery pipe shall meet the requirements of 4.5.4.
5.3.5 Temperature control test of freezing probe
After the equipment has been debugged, fill up with liquid nitrogen and put it in a standby state. The low temperature probe should be fixed and supported, exposed to the air, and no surrounding
Significant air flow and heat source.
Attach and fix the temperature sensor of the temperature measuring equipment to the freezing area of the low temperature probe. The sensor shape of the temperature measuring equipment should be able to match the temperature measurement point.
The close contact, the heat capacity is small.
Set the working temperature of the device to half of the full scale T1, and turn on the device to make it work.
After the temperature measuring equipment shows that the reading is basically stable, observe and record the reading T2 of the temperature measuring equipment. Comparing T1 and T2, it should conform to 4.5.5
Claim.
Set the working temperature of the equipment to the lowest working temperature and repeat the above process.
Insert the low-temperature probe into the gelatin gel and fix the support. The gelatin gel is prepared by heating 4% gelatin solution to 42°C and cooling.
Set the working temperature of the equipment to half of the full scale and the lowest working temperature in turn, and record the reading after the temperature stabilizes, which should conform to 4.5.
Requirements.
5.3.6 Thermometer accuracy test
Turn on the device and confirm that its thermometer is in normal working condition.
Immerse the part of the device equipped with a temperature sensor in a container filled with liquid nitrogen, and record the device's display temperature T1 after the liquid level is basically calm.
After replacing the liquid with ice-water mixture and boiling water, repeat the above process.
Refer to the comparison of the temperature of liquid nitrogen, ice-water mixture and boiling water, which should meet the requirements of 4.5.6.
5.3.7 Performance test of low temperature solenoid valve
Fill the equipment with liquid nitrogen of 2/3 storage capacity and pressurize it. After the liquid nitrogen storage reaches the working pressure, the solenoid valve is opened and closed 3 times.
Every 5min interval, no freezing or jamming phenomenon. Should meet the requirements of 4.5.7.
5.3.9 Non-freezing zone temperature test of low temperature probe
After the equipment has been debugged, fill up with liquid nitrogen and put it in a standby state. The low temperature probe should be fixed and supported, exposed to the air, and no surrounding
Significant air flow and heat source.
Set the working temperature of the equipment to the lowest working temperature, and turn on the equipment to make it in working condition.
After turning on for 10 minutes, observe the surface of the non-freezing zone of the low temperature probe, and it should meet the requirements of 4.7.10.
5.4 Alarm function test
5.4.1 Sound test of alarm signal
When using a sound level meter to actually measure the alarm sound, it should meet the requirements of 4.6.1.
5.4.2 Pressure alarm test (using the pressure control method in the memory)
Using a pressurizing device to actually adjust the pressure in the liquid nitrogen storage to exceed the range of the rated working pressure should meet the requirements of 4.6.2....