A testing device and method for filters based on hemodialysis equipment

Abstract

This invention provides a testing device and method for filters used in hemodialysis equipment, belonging to the field of medical device testing technology. It includes a temperature control component, a drive component, a detection unit, and a control unit. The temperature control component comprises a heating reservoir for heating disinfectant and a cooling reservoir for cooling disinfectant, which are connected to the filter via a first circulation channel and a second circulation channel, respectively. The drive component drives the disinfectant to circulate in the first and second circulation channels. The detection unit acquires parameters of the first and second circulation channels in real time. The control unit, based on these parameters, controls the temperature control component and the drive component to adjust the disinfectant in the circulation channels to target parameters. This invention simulates the environmental conditions during hemodialysis treatment and disinfection to perform highly automated performance testing on the filter, thereby determining its long-term stability.

Description

Technical Field

[0001] This invention relates to the field of medical device testing technology, and in particular to a testing device and method for filters based on hemodialysis equipment. Background Technology

[0002] Endotoxin filters are key safety components of hemodialysis equipment. They mainly remove endotoxins, microorganisms, and insoluble particulate matter from the dialysate through the retention of the filter membrane.

[0003] To determine the lifespan of an endotoxin filter in actual use, it is generally necessary to test its performance. Currently, this is mainly done by installing the endotoxin filter on a hemodialysis machine for actual testing.

[0004] However, this method requires the use of expensive hemodialysis machines, and the testing process requires the continuous consumption of special consumables such as dialysis fluid and disinfectants, resulting in high initial testing costs. In addition, the testing process also requires manual intervention in the operation of the equipment, such as parameter adjustment, leading to a large labor input. Summary of the Invention

[0005] Based on this, the purpose of this invention is to provide a testing device and method for filters based on hemodialysis equipment, which aims to perform highly automated performance testing on endotoxin filters by simulating the environmental conditions during hemodialysis treatment and disinfection, thereby determining the long-term stability of the endotoxin filters.

[0006] To achieve the above objectives, in a first aspect, the present invention proposes a testing device for filters based on hemodialysis equipment, used for testing endotoxin filters, including a temperature regulation component, a drive component, a detection unit, and a control unit. The temperature regulation component includes a heating reservoir and a cooling reservoir for storing and regulating the temperature of the disinfectant. The heating reservoir and the cooling reservoir are connected to an endotoxin filter via a first circulation channel and a second circulation channel, respectively. The heating reservoir heats the disinfectant in the first circulation channel, and the cooling reservoir cools the disinfectant in the second circulation channel. The drive component is connected to the first circulation channel and the second circulation channel and drives the disinfectant to circulate in the first circulation channel and the second circulation channel. The detection unit acquires a first parameter of the disinfectant in the first circulation channel and a second parameter of the disinfectant in the second circulation channel in real time. The control unit adjusts the disinfectant in the first circulation channel to a first target parameter by controlling the heating reservoir and the drive component according to the first parameter. The control unit also adjusts the disinfectant in the second circulation channel to a second target parameter by controlling the cooling reservoir and the drive component according to the second parameter. The first parameter, the first target parameter, the second parameter, and the second target parameter all include the temperature, pressure, and flow rate of the disinfectant.

[0007] In addition, the testing device for filters based on hemodialysis equipment according to the present invention may also have the following additional technical features:

[0008] Furthermore, the heated storage tank is provided with a first inlet and a first outlet. A first branch pipe that can be opened and closed is provided between the first outlet and the input end of the drive component. A second branch pipe is provided between the output end of the drive component and the input end of the endotoxin filter. A third branch pipe that can be opened and closed is provided between the output end of the endotoxin filter and the first inlet.

[0009] Furthermore, the cooling liquid storage tank is provided with a second inlet and a second outlet, a fourth branch pipe that can be opened and closed is provided between the second outlet and the input end of the drive component, and a fifth branch pipe that can be opened and closed is provided between the output end of the endotoxin filter and the second inlet.

[0010] Furthermore, the testing device for the filter based on the hemodialysis equipment also includes a flushing assembly, which is used to deliver cleaning agent into the endotoxin filter through a cleaning channel. The detection unit is also used to acquire a third parameter of the cleaning agent in the cleaning channel in real time. The control unit is also used to adjust the cleaning agent in the circulation channel to a third target parameter by controlling the drive assembly according to the third parameter. The third parameter and the third target parameter both include the flow rate and pressure of the cleaning agent.

[0011] Furthermore, the flushing assembly includes an openable and closable sixth branch pipe and an openable and closable seventh branch pipe. The output end of the sixth branch pipe is connected to the input end of the drive assembly, and the input end of the sixth branch pipe is used to continuously input cleaning agent. The input end of the seventh branch pipe is connected to the output end of the endotoxin filter, and the output end of the seventh branch pipe is used to continuously output cleaning agent.

[0012] Secondly, the present invention also proposes a testing method for filters based on hemodialysis equipment, which is implemented by the aforementioned testing device for filters based on hemodialysis equipment, including an accelerated aging test step and a cooling test step, wherein the accelerated aging test step and the cooling test step are performed alternately for a set time.

[0013] The accelerated aging test steps specifically include:

[0014] The detection unit acquires the first parameter of the disinfectant in the first circulating channel in real time.

[0015] The control unit adjusts the disinfectant in the first circulation channel to the first target parameter by controlling the heated storage tank and the drive assembly according to the first parameter, and continues for a first preset time.

[0016] The first parameter and the first target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant.

[0017] The cooling test steps specifically include:

[0018] The detection unit acquires the second parameter of the disinfectant in the second circulation channel in real time.

[0019] The control unit adjusts the disinfectant in the second circulation channel to the second target parameter by controlling the cooling liquid tank and the drive assembly according to the second parameter, and continues for a second preset time.

[0020] The second parameter and the second target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant.

[0021] During the alternating execution of the accelerated aging test step and the cooling test step for a set time, the test is stopped when the detection unit detects that the pressure and / or flow rate of the disinfectant do not meet the preset conditions.

[0022] Furthermore, the disinfectant used in the accelerated aging test step is selected from citric acid or glycolic acid, and the mass concentration of both citric acid and glycolic acid is 0.8%. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank and the drive component and continuing for a first preset time specifically includes: the control unit controls the heating storage tank to heat the citric acid or glycolic acid to 80℃~95℃, and the control unit controls the drive component to inject the citric acid or glycolic acid into the first circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa, and the citric acid or glycolic acid continuously flows in the first circulation channel for 60min;

[0023] Alternatively, the disinfectant used in the accelerated aging test step is selected from sodium hypochlorite or peracetic acid, with a mass concentration of 0.1% for both sodium hypochlorite and peracetic acid. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank and the drive assembly, and continuing for a first preset time, specifically includes: the control unit controlling the heating storage tank to heat the sodium hypochlorite or peracetic acid to 36.8℃~37.2℃; the control unit controlling the drive assembly to inject the sodium hypochlorite or peracetic acid into the first circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa; and the sodium hypochlorite or peracetic acid continuously flowing in the first circulation channel for 60min.

[0024] Furthermore, the disinfectant used in the cooling test step is selected from citric acid, and the mass concentration of citric acid is 0.8%. The step of adjusting the disinfectant in the second circulation channel to the second target parameter by controlling the cooling storage tank and the drive component and continuing for the second preset time specifically includes: the control unit controls the cooling storage tank to cool the citric acid to 22℃~26℃, and the control unit controls the drive component to inject the citric acid into the second circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa, and the citric acid continuously flows in the second circulation channel for 10min.

[0025] Furthermore, the testing apparatus also includes a rinsing assembly for delivering a cleaning agent into the endotoxin filter through a cleaning channel. After the accelerated aging test step and the cooling test step are performed alternately, the testing method further includes a rinsing step, which includes:

[0026] The detection unit acquires the third parameter of the cleaning agent in the cleaning channel in real time.

[0027] The control unit adjusts the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component according to the third parameter, and continues for a third preset time.

[0028] The third parameter and the third target parameter both include the flow rate and pressure of the cleaning agent.

[0029] Furthermore, the cleaning agent used in the rinsing step is selected from purified water, and the step of adjusting the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component specifically includes: the control unit controls the drive component to inject purified water into the cleaning channel at a flow rate of 600mL / min to 700mL / min and a pressure of 0.10MPa to 0.11MPa.

[0030] The beneficial effects of this invention include at least the following: by constructing a circulation channel using a non-hemodialysis machine and precisely controlling the operating environment within the circulation channel by adjusting the drive components through a control unit, the internal conditions during treatment and disinfection of a hemodialysis machine, such as temperature, pressure, and flow rate, can be highly simulated. This allows for efficient verification of the expected service life of the endotoxin filter on the hemodialysis machine. Furthermore, the disinfectants used in the aging acceleration and cooling steps are recycled, resulting in lower consumption and reduced testing costs compared to existing technologies. In addition, the entire accelerated aging and cooling process is fully automated by the control unit, requiring no human intervention, resulting in high testing efficiency and reduced labor costs. Attached Figure Description

[0031] Figure 1 This is a first-view structural schematic diagram of the testing device for a filter based on a hemodialysis device in an embodiment of the present invention;

[0032] Figure 2 This is a second-view structural schematic diagram of the testing device for a filter based on a hemodialysis device in an embodiment of the present invention;

[0033] Figure 3 This is a flowchart of a testing method for filters based on hemodialysis equipment in an embodiment of the present invention;

[0034] Explanation of key component symbols:

[0035] Heating storage tank 110, first inlet 111, first outlet 112, first branch pipe 113, first switch valve 114, second branch pipe 115, third branch pipe 116, second switch valve 117, damper 118, cooling storage tank 120, second inlet 121, second outlet 122, fourth branch pipe 123, third switch valve 124, fifth branch pipe 125, fourth switch valve 126, drive assembly 200, temperature sensor 310, pressure sensor 320, endotoxin filter 400, sixth branch pipe 510, seventh branch pipe 520, fifth switch valve 530, sixth switch valve 540, pressure reducing valve 550, eighth branch pipe 600, seventh switch valve 610;

[0036] The following detailed description, in conjunction with the accompanying drawings, will further illustrate the present invention. Detailed Implementation

[0037] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Several embodiments of the invention are illustrated in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

[0038] It should be noted that when a component is said to be "fixed to" another component, it can be directly on the other component or there may be an intervening component. When a component is said to be "connected to" another component, it can be directly connected to the other component or there may be an intervening component. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0040] Please refer to Figures 1 to 2This invention provides a testing device for a filter based on a hemodialysis device, used to test an endotoxin filter 400. The testing device includes a temperature control component, a drive component 200, a detection unit, and a control unit. The temperature control component includes a heating reservoir 110 and a cooling reservoir 120 for storing and regulating the temperature of a disinfectant. The heating reservoir 110 stores a disinfectant, selected from citric acid, glycolic acid, sodium hypochlorite, or peracetic acid, in its storage chamber. The storage chamber of the heating reservoir 110 is connected to an inlet and outlet, which are connected by pipes to form a first circulation channel. The heating reservoir 110 is used to heat the disinfectant in the first circulation channel, and the endotoxin filter 400 is connected in series in the first circulation channel. The cooling reservoir 120 stores disinfectant, selected from citric acid, within its storage chamber. The storage chamber of the cooling reservoir 120 is connected to an inlet and outlet via pipes to form a second circulation channel. The cooling reservoir 120 cools the disinfectant in the second circulation channel. An endotoxin filter 400 is also connected in series in the second circulation channel. A drive assembly 200 is connected to both the first and second circulation channels to drive the disinfectant to circulate within them. A detection unit is used to acquire, in real-time, first parameters of the disinfectant in the first circulation channel and second parameters of the disinfectant in the second circulation channel.

[0041] During testing, the endotoxin filter 400 was first subjected to an accelerated aging test. Specifically, the control unit adjusted the disinfectant in the first circulation channel to the first target parameter by controlling the heating reservoir 110 and the drive assembly 200 according to the first parameter. Then, the endotoxin filter 400 was subjected to a cooling test. Specifically, the control unit adjusted the disinfectant in the second circulation channel to the second target parameter by controlling the cooling reservoir 120 and the drive assembly 200 according to the second parameter. The accelerated aging test and cooling test were then performed alternately, and the test was stopped after a set duration. The first parameter, the first target parameter, the second parameter, and the second target parameter all include the temperature, pressure, and flow rate of the disinfectant.

[0042] During accelerated aging and cooling tests, the test is stopped when the detection unit detects that the pressure and / or flow rate of the disinfectant do not meet preset conditions. For example, when the detection unit detects a change in the pressure of the disinfectant in the first or second circulation channel and that the pressure is lower than a preset pressure, the control unit controls the drive assembly 200 to stop supplying disinfectant to the endotoxin filter 400.

[0043] In some optional embodiments, multiple endotoxin filters 400 can be provided, and the multiple endotoxin filters 400 are cascaded together and connected in series in the first circulation channel and the second circulation channel, so that the endotoxin filters 400 can be tested in batches, thereby improving the testing efficiency.

[0044] In some optional embodiments, the drive assembly 200 includes a diaphragm metering pump that enables high-precision metering, ensuring stable flow of disinfectant in the first and second circulation channels at the required flow rate and pressure for the test quality, thereby improving test accuracy.

[0045] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, the heating storage tank 110 has a first inlet 111 and a first outlet 112. A first branch pipe 113 is provided between the first outlet 112 and the input end of the diaphragm metering pump. A first switching valve 114 is provided on the first branch pipe 113, and the first switching valve 114 is electrically connected to the control unit, which can control the opening and closing of the first branch pipe 113. A second branch pipe 115 is provided between the output end of the diaphragm metering pump and the input end of the endotoxin filter 400. A third branch pipe 116 is provided between the output end of the endotoxin filter 400 and the first inlet 111. A second switching valve 117 is provided on the third branch pipe 116, and the second switching valve 117 is electrically connected to the control unit, which can control the opening and closing of the third branch pipe 116. Optionally, the first switching valve 114 and the second switching valve 117 can be solenoid valves.

[0046] In this embodiment, the heating storage tank 110, the first branch pipe 113, the diaphragm metering pump, the second branch pipe 115, the endotoxin filter 400, and the third branch pipe 116 form a first circulation channel. The endotoxin filter 400 is subjected to accelerated aging test by circulating disinfectant heated to a preset temperature in the first circulation channel.

[0047] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, the cooling liquid storage tank 120 is provided with a second inlet 121 and a second outlet 122. A fourth branch pipe 123 is provided between the second outlet 122 and the input end of the diaphragm metering pump. A third switching valve 124 is provided on the fourth branch pipe 123. The third switching valve 124 is electrically connected to the control unit, which can control the opening and closing of the fourth branch pipe 123. A fifth branch pipe 125 is provided between the output end of the endotoxin filter 400 and the second inlet 121. A fourth switching valve 126 is provided on the fifth branch pipe 125. The fourth switching valve 126 is electrically connected to the control unit, which can control the opening and closing of the fifth branch pipe 125. Optionally, the third switching valve 124 and the fourth switching valve 126 can be solenoid valves.

[0048] In this embodiment, the cooling liquid storage tank 120, the fourth branch pipe 123, the diaphragm metering pump, the second branch pipe 115, the endotoxin filter 400, and the fifth branch pipe 125 form the second circulation channel. Disinfectant cooled to a preset temperature circulates within this second circulation channel to perform a cooling test on the endotoxin filter 400. Since the first and second circulation channels share the same flow path as the cascaded section of the diaphragm metering pump, the second branch pipe 115, and the endotoxin filter 400, there is no need to reconnect the endotoxin filter 400 piping when switching between accelerated aging and cooling test operations. The switching is automatic by controlling the opening and closing of the first switching valve 114, the second switching valve 117, the third switching valve 124, and the fourth switching valve 126, without manual intervention. Specifically, during the accelerated aging test, the control unit controls the first switching valve 114 and the second switching valve 117 to open, and controls the third switching valve 124 and the fourth switching valve 126 to close; during the cooling test, the control unit controls the first switching valve 114 and the second switching valve 117 to close, and controls the third switching valve 124 and the fourth switching valve 126 to open.

[0049] In some optional embodiments, the testing apparatus further includes a rinsing assembly to rinse away residual disinfectant within the endotoxin filter 400. Specifically, the rinsing assembly is connected to the endotoxin filter 400 via a cleaning channel to deliver a cleaning agent into the endotoxin filter 400. Preferably, the cleaning agent is selected from purified water.

[0050] During the cleaning of the endotoxin filter 400, a third parameter of the cleaning agent in the cleaning channel is acquired in real time by a detection unit. This third parameter includes the flow rate and pressure of the cleaning agent. Based on this third parameter, the control unit adjusts the cleaning agent in the cleaning channel to a third target parameter via the control drive component 200, and maintains this adjustment for a third preset time. Both the third parameter and the third target parameter include the flow rate and pressure of the cleaning agent, and the third preset time can be selected based on empirical values.

[0051] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, the flushing assembly includes a sixth branch pipe 510 and a seventh branch pipe 520. The output end of the sixth branch pipe 510 is connected to the input end of the diaphragm metering pump. A fifth switching valve 530 is installed on the sixth branch pipe 510, and the fifth switching valve 530 is electrically connected to the control unit, which can control the on / off state of the sixth branch pipe 510. The input end of the seventh branch pipe 520 is connected to the output end of the endotoxin filter 400. A sixth switching valve 540 is installed on the seventh branch pipe 520, and the sixth switching valve 540 is electrically connected to the control unit, which can control the on / off state of the seventh branch pipe 520. Optionally, the fifth switching valve 530 and the sixth switching valve 540 can be solenoid valves.

[0052] In this embodiment, the sixth branch pipe 510, the diaphragm metering pump, the second branch pipe 115, the endotoxin filter 400, and the seventh branch pipe 520 constitute a cleaning channel. Cleaning agent is injected into the cleaning channel to clean the residual disinfectant in the endotoxin filter 400. Specifically, during cleaning, clean cleaning agent is continuously input into the input end of the sixth branch pipe 510, and cleaning agent carrying residual disinfectant is continuously discharged from the output end of the seventh branch pipe 520. Since the first circulation channel, the second circulation channel, and the cleaning channel share the same channel as the cascaded section of the diaphragm metering pump, the second branch pipe 115, and the endotoxin filter 400, there is no need to reconnect the endotoxin filter 400 pipeline when switching between cooling test operations and cleaning operations. Only the opening and closing of the first switch valve 114, the second switch valve 117, the third switch valve 124, the fourth switch valve 126, the fifth switch valve 530, and the sixth switch valve 540 are controlled, thus achieving automatic switching without manual intervention. Specifically, during the accelerated aging test, the control unit controls the first switching valve 114 and the second switching valve 117 to open, and controls the third switching valve 124, the fourth switching valve 126, the fifth switching valve 530, and the sixth switching valve 540 to close. During the cooling test, the control unit controls the first switching valve 114, the second switching valve 117, the fifth switching valve 530, and the sixth switching valve 540 to close, and controls the third switching valve 124 and the fourth switching valve 126 to open. After the accelerated aging test and the cooling test have alternated for a set time, the control unit controls the first switching valve 114, the second switching valve 117, the third switching valve 124, and the fourth switching valve 126 to close, and controls the fifth switching valve 530 and the sixth switching valve 540 to open.

[0053] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, a damper 118 is provided on the second branch pipe 115 at the output end of the diaphragm metering pump. The damper 118 reduces the periodic pressure fluctuations generated during the operation of the diaphragm metering pump to a safe range through the synergistic effect of hydraulic buffering and gas compensation, thereby eliminating the water hammer effect and reducing the risk of pipeline resonance, and ensuring the pressure stability of the system under precision metering conditions.

[0054] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, the input end of the sixth branch pipe 510 is equipped with a pressure reducing valve 550. The pressure reducing valve 550 can reduce the pressure of the input cleaning agent, that is, the high-pressure cleaning agent is not directly injected into the cleaning channel, thereby avoiding damage to parts including the endotoxin filter 400 due to pressure impact.

[0055] In some optional embodiments, the detection unit includes a temperature sensor 310, a pressure sensor 320 connected to the first circulation channel, the second circulation channel, and the cleaning channel, as well as a concentration detection device for detecting the concentration of disinfectant flowing in the first and second circulation channels. To reduce costs, the temperature sensor 310, the pressure sensor 320, and the concentration detection device can all be located on a channel shared by the first and second circulation channels, i.e., on the channel in which the diaphragm metering pump, the second branch pipe 115, and the endotoxin filter 400 are cascaded.

[0056] In some alternative embodiments, such as Figure 1 , Figure 2 As shown, an eighth branch pipe 600 is connected in parallel to the flow channel shared by the first and second circulation channels. A seventh switching valve 610 is installed on the eighth branch pipe 600, and the seventh switching valve 610 is electrically connected to the control unit. The control unit can control the on / off state of the eighth branch pipe 600, and the output end of the eighth branch pipe 600 is connected to a concentration detection device. In this embodiment, by controlling the on / off state of the seventh switching valve 610, the control unit enables the concentration detection device to sample and test the disinfectant at preset intervals, thereby determining whether the concentration of the disinfectant meets the test requirements.

[0057] Please refer to Figure 3 The present invention provides a testing method for a filter based on a hemodialysis device, which is implemented by the aforementioned testing device for a filter based on a hemodialysis device. The testing method includes an accelerated aging test step S100 and a cooling test step S200, and the accelerated aging test step S100 and the cooling test step S200 are performed alternately for a set time.

[0058] Step S100, the accelerated aging test step, specifically includes:

[0059] The first parameter of the disinfectant in the first circulation channel is obtained in real time through the detection unit;

[0060] The control unit adjusts the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank 110 and the drive assembly 200 according to the first parameter, and continues for a first preset time.

[0061] The first parameter and the first target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant;

[0062] Step S200, the cooling test step specifically includes:

[0063] The second parameter of the disinfectant in the second circulation channel is obtained in real time through the detection unit;

[0064] The control unit adjusts the disinfectant in the second circulation channel to the second target parameter by controlling the cooling liquid tank 120 and the drive assembly 200 according to the second parameter, and continues for the second preset time.

[0065] The second parameter and the second target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant.

[0066] During the alternating execution of the accelerated aging test step S100 and the cooling test step S200 for a set time, the test is stopped when the detection unit detects that the pressure and / or flow rate of the disinfectant do not meet the preset conditions.

[0067] For example, when the detection unit detects a change in the pressure of the disinfectant in the first or second circulation channel and the pressure of the disinfectant is less than a preset pressure, the control unit controls the drive assembly 200 to stop inputting disinfectant into the endotoxin filter 400.

[0068] In some optional embodiments, the disinfectant used in the accelerated aging test step S100 is selected from citric acid or glycolic acid, both with a mass concentration of 0.8%. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank 110 and the drive assembly 200 and continuing for a first preset time specifically includes:

[0069] The control unit controls the heating storage tank 110 to heat citric acid or glycolic acid to 80℃~95℃;

[0070] The control unit controls the drive assembly 200 to inject citric acid or glycolic acid into the first circulation channel at a flow rate of 600 mL / min to 700 mL / min and a pressure of 0.10 MPa to 0.11 MPa. The citric acid or glycolic acid flows continuously in the first circulation channel for 60 min.

[0071] In some optional embodiments, the disinfectant used in the accelerated aging test step S100 is selected from sodium hypochlorite or peracetic acid, both with a mass concentration of 0.1%. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank 110 and the drive assembly 200 and continuing for a first preset time specifically includes:

[0072] The control unit controls the heating storage tank 110 to heat sodium hypochlorite or peracetic acid to 36.8℃~37.2℃;

[0073] The control unit controls the drive assembly 200 to inject sodium hypochlorite or peracetic acid into the first circulation channel at a flow rate of 600 mL / min to 700 mL / min and a pressure of 0.10 MPa to 0.11 MPa. The sodium hypochlorite or peracetic acid flows continuously in the first circulation channel for 60 min.

[0074] In some optional embodiments, the disinfectant used in the cooling test step S200 is selected from citric acid, and the mass concentration of citric acid is 0.8%. The step of adjusting the disinfectant in the second circulation channel to the second target parameter by controlling the cooling liquid storage tank 120 and the drive assembly 200 and continuing for a second preset time specifically includes:

[0075] The control unit controls the cooling liquid storage tank 120 to cool the citric acid to 22℃~26℃;

[0076] The control unit controls the drive assembly 200 to inject citric acid into the second circulation channel at a flow rate of 600 mL / min to 700 mL / min and a pressure of 0.10 MPa to 0.11 MPa. The citric acid flows continuously in the second circulation channel for 10 min.

[0077] In some optional embodiments, the accelerated aging test step S100 and the cooling test step S200 are alternately performed for 175 hours.

[0078] In some optional embodiments, the testing apparatus further includes a rinsing assembly for delivering a cleaning agent into the endotoxin filter through a cleaning channel. After the accelerated aging test step S100 and the cooling test step S200 are performed alternately, the testing method further includes a rinsing step S300.

[0079] The rinsing step S300 specifically includes:

[0080] The third parameter of the cleaning agent in the cleaning channel is obtained in real time through the detection unit;

[0081] The control unit adjusts the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component 200 according to the third parameter, and continues for the third preset time.

[0082] The third parameter and the third target parameter both include the flow rate and pressure of the cleaning agent, and the third preset time can be selected based on empirical values.

[0083] In some optional embodiments, the cleaning agent used in the rinsing step S300 is selected from purified water, and the step of adjusting the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component 200 specifically includes:

[0084] The control unit controls the drive assembly to inject purified water into the cleaning channel at a flow rate of 600 mL / min to 700 mL / min and a pressure of 0.10 MPa to 0.11 MPa.

[0085] In some alternative embodiments, the control unit may be implemented using any one or a combination of the following techniques known in the art, such as discrete logic circuits having logic gates for implementing logic functions on data signals, application-specific integrated circuits (ASICs) having suitable combinational logic gates, programmable gate arrays (PGAs), field-programmable gate arrays (FPGAs), etc.

[0086] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0087] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of protection of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A testing device for filters in hemodialysis equipment, characterized in that, The testing apparatus for testing endotoxin filters includes: A temperature regulating component includes a heating reservoir and a cooling reservoir for storing and regulating the temperature of a disinfectant. The heating reservoir and the cooling reservoir are respectively connected to an endotoxin filter through a first circulation channel and a second circulation channel. The heating reservoir is used to heat the disinfectant in the first circulation channel, and the cooling reservoir is used to cool the disinfectant in the second circulation channel. A driving component, connected to the first circulation channel and the second circulation channel, is used to drive the disinfectant to circulate in the first circulation channel and the second circulation channel; The detection unit is used to acquire, in real time, the first parameter of the disinfectant in the first circulation channel and the second parameter of the disinfectant in the second circulation channel; The control unit is configured to adjust the disinfectant in the first circulation channel to a first target parameter by controlling the heating storage tank and the drive assembly according to the first parameter, and is also configured to adjust the disinfectant in the second circulation channel to a second target parameter by controlling the cooling storage tank and the drive assembly according to the second parameter; The first parameter, the first target parameter, the second parameter, and the second target parameter all include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant. The heated storage tank is provided with a first inlet and a first outlet. A first branch pipe that can be opened and closed is provided between the first outlet and the input end of the drive component. A second branch pipe is provided between the output end of the drive component and the input end of the endotoxin filter. A third branch pipe that can be opened and closed is provided between the output end of the endotoxin filter and the first inlet. The cooling liquid storage tank is provided with a second water inlet and a second water outlet. A fourth branch pipe that can be opened and closed is provided between the second water outlet and the input end of the drive component. A fifth branch pipe that can be opened and closed is provided between the output end of the endotoxin filter and the second water inlet. The testing device for the filter based on the hemodialysis equipment further includes a flushing assembly for delivering cleaning agent to the endotoxin filter through a cleaning channel. The detection unit is also used to acquire a third parameter of the cleaning agent in the cleaning channel in real time. The control unit is also used to adjust the cleaning agent in the circulation channel to a third target parameter by controlling the drive assembly according to the third parameter. The third parameter and the third target parameter both include the flow rate and pressure of the cleaning agent.

2. The testing device for filters based on hemodialysis equipment according to claim 1, characterized in that, The flushing assembly includes: A sixth branch pipe that can be opened and closed, the output end of the sixth branch pipe is connected to the input end of the drive assembly, and the input end of the sixth branch pipe is used for continuous input of cleaning agent; A seventh branch pipe that can be opened and closed, the input end of the seventh branch pipe is connected to the output end of the endotoxin filter, and the output end of the seventh branch pipe is used to continuously output cleaning agent.

3. A test method for filters based on hemodialysis equipment, characterized in that, The test apparatus for use with a filter based on a hemodialysis device as described in claim 1 or 2 includes an accelerated aging test step and a cooling test step, wherein the accelerated aging test step and the cooling test step are performed alternately for a set time. The accelerated aging test steps specifically include: The detection unit acquires the first parameter of the disinfectant in the first circulating channel in real time. The control unit adjusts the disinfectant in the first circulation channel to the first target parameter by controlling the heated storage tank and the drive assembly according to the first parameter, and continues for a first preset time. The first parameter and the first target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant. The cooling test steps specifically include: The detection unit acquires the second parameter of the disinfectant in the second circulation channel in real time. The control unit adjusts the disinfectant in the second circulation channel to the second target parameter by controlling the cooling liquid tank and the drive assembly according to the second parameter, and continues for a second preset time. The second parameter and the second target parameter both include the temperature of the disinfectant, the pressure of the disinfectant, and the flow rate of the disinfectant. During the alternating execution of the accelerated aging test step and the cooling test step for a set time, the test is stopped when the detection unit detects that the pressure and / or flow rate of the disinfectant do not meet the preset conditions.

4. The test method for filters based on hemodialysis equipment according to claim 3, characterized in that, The disinfectant used in the accelerated aging test step is selected from citric acid or glycolic acid, and the mass concentration of both citric acid and glycolic acid is 0.8%. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank and the drive component and continuing for a first preset time specifically includes: the control unit controls the heating storage tank to heat the citric acid or glycolic acid to 80℃~95℃, and the control unit controls the drive component to inject the citric acid or glycolic acid into the first circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa, and the citric acid or glycolic acid continues to flow in the first circulation channel for 60min. Alternatively, the disinfectant used in the accelerated aging test step is selected from sodium hypochlorite or peracetic acid, with a mass concentration of 0.1% for both sodium hypochlorite and peracetic acid. The step of adjusting the disinfectant in the first circulation channel to the first target parameter by controlling the heating storage tank and the drive assembly, and continuing for a first preset time, specifically includes: the control unit controlling the heating storage tank to heat the sodium hypochlorite or peracetic acid to 36.8℃~37.2℃; the control unit controlling the drive assembly to inject the sodium hypochlorite or peracetic acid into the first circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa; and the sodium hypochlorite or peracetic acid continuously flowing in the first circulation channel for 60min.

5. The test method for filters based on hemodialysis equipment according to claim 3, characterized in that, The disinfectant used in the cooling test step is selected from citric acid, and the mass concentration of citric acid is 0.8%. The step of adjusting the disinfectant in the second circulation channel to the second target parameter by controlling the cooling storage tank and the drive component and continuing for the second preset time specifically includes: the control unit controls the cooling storage tank to cool the citric acid to 22℃~26℃, the control unit controls the drive component to inject the citric acid into the second circulation channel at a flow rate of 600mL / min~700mL / min and a pressure of 0.10MPa~0.11MPa, and the citric acid flows continuously in the second circulation channel for 10min.

6. The test method for filters based on hemodialysis equipment according to claim 3, characterized in that, The testing apparatus further includes a rinsing assembly for delivering cleaning agent into the endotoxin filter through a cleaning channel. After the accelerated aging test step and the cooling test step are performed alternately, the testing method further includes a rinsing step, which specifically includes: The detection unit acquires the third parameter of the cleaning agent in the cleaning channel in real time. The control unit adjusts the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component according to the third parameter, and continues for a third preset time. The third parameter and the third target parameter both include the flow rate and pressure of the cleaning agent.

7. The test method for filters based on hemodialysis equipment according to claim 6, characterized in that, The cleaning agent used in the rinsing step is selected from purified water. The step of adjusting the cleaning agent in the cleaning channel to the third target parameter by controlling the drive component specifically includes: the control unit controls the drive component to inject purified water into the cleaning channel at a flow rate of 600 mL / min to 700 mL / min and a pressure of 0.10 MPa to 0.11 MPa.

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