Endoscope operation unit service life evaluation method

Abstract

The present application relates to a kind of endoscope operating part service life evaluation method, including step 1: high temperature accelerated test simulates working day working condition test;Step 2: high temperature accelerated test simulates working day non-working state test;Step 3: high temperature accelerated test simulates non-working day test;Step 4: hydrogen peroxide spray test simulates chemical agent disinfection and residual influence test;Step 5: according to the verification time of test object, step 1 to step 4 are cycled until it meets the verification time length, end cycle, and verify the performance index of endoscope operating part.This scheme is simulated by high temperature aging acceleration and chemical reagent disinfection acceleration test method, and the aging condition of endoscope operating part in actual use process is fully simulated.At the same time, the test cycle is designed in this scheme, and the use process of endoscope operating part can be better simulated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a method for evaluating the service life of an endoscope operating part. Background Technology

[0002] Electronic endoscopes play a vital role in diagnostic and therapeutic activities within the endoscopy rooms of large and medium-sized hospitals in China. The endoscope operating section is the part that doctors operate manually during examinations and treatments. According to medical device registration requirements, the endoscope operating section needs a defined service life, ensuring safe and effective use within that period. Current research on verifying the service life of endoscopes mostly focuses on single influencing factors, such as verifying endoscope lifespan under high temperature or high humidity conditions. However, in practical applications, the service life of endoscopes is often influenced by multiple factors, with temperature and chemical corrosion being the main factors. To verify the service life of endoscopes under multi-factor conditions, various technical methods have been employed. One existing endoscope lifespan verification method and electronic device includes the following steps: setting temperature test parameters, humidity test parameters, and time thresholds to conduct aging tests on the endoscope and its materials; conducting mechanical structure tests on the endoscope; and then sequentially verifying the endoscope's functional performance effectiveness, sterilization effectiveness, chemical resistance, and material chemical properties. This method utilizes high temperature and humidity to increase test stress, accelerating the aging of the endoscope to simulate the expected maximum working life of the product. Then, mechanical structure tests are conducted on the product to verify fatigue tests on different parts of the endoscope. Finally, relevant tests on the endoscope are carried out to verify that the method is close to the actual use state of the endoscope.

[0003] However, the chemical corrosion test in this method is a verification test after the endoscope's high-temperature life test and mechanical structure life test. It cannot reflect the repeatability of disinfection during endoscope use, and the amount of chemical agent used is not quantified in the test. Therefore, the chemical corrosion test in this method cannot reflect the corrosion effect of endoscope disinfection during actual use. Summary of the Invention

[0004] To address the problem that chemical corrosion tests in the aforementioned technical solutions fail to reflect the corrosion effects of disinfection on the endoscope during actual use, this invention provides a method for evaluating the service life of the endoscope operating section. The method in this solution for assessing the impact of chemical disinfection on the service life of the endoscope operating section can reflect the corrosion effects of disinfection on the endoscope operating section during actual use.

[0005] The technical solution adopted in this invention is: a method for evaluating the service life of an endoscope operating part, comprising the following steps:

[0006] Step 1: Conduct a high-temperature accelerated test to simulate the working conditions of a normal workday, based on the set service life 'a'.

[0007] Step 2: Conduct a high-temperature accelerated test to simulate a non-working state during a workday, based on the set service life 'a'.

[0008] Step 3: Conduct a high-temperature accelerated test to simulate a non-working day test, based on the set service life 'a'.

[0009] Step 4: Conduct a hydrogen peroxide spray test to simulate the effects of chemical disinfection and residues, based on the set service life 'a'.

[0010] Step 5: Based on the required verification time b for the test subject, repeat steps 1 to 4 until the verification time b is met, then end the loop and verify the performance indicators of the endoscope operating unit. The verification time b is m times the service life a, where m is an integer.

[0011] The experimental profile of this scheme is divided into three segments: accelerated high-temperature testing during non-operating processes, accelerated high-temperature testing during endoscopic examination, and accelerated testing during chemical disinfection. Simultaneously, to better simulate the use of the endoscope operating unit, this experimental design for evaluating the service life of the endoscope operating unit is cyclical, with each cycle verifying the service life for one quarter. This invention, through a testing method of "accelerated high-temperature aging + accelerated chemical disinfection," fully simulates the aging process of the endoscope operating unit during actual use and conducts targeted accelerated testing, solving the problem of service life assessment and providing a basis for medical device registration.

[0012] Preferably, when evaluating the service life of the endoscopic operating unit, the smallest unit of service life 'a' is 'c', where 'c' is one day in length, and service life 'a' is the smallest unit of service life 'c'. The minimum unit usage period c is calculated by multiplying the working day duration e and the non-working day duration based on the ratio of working days to non-working days within a year. Based on the assumption that the endoscopy operating room is used 6 work cycles per weekday, with an average routine endoscopic examination taking approximately 30 minutes and a complete disinfection time of approximately 45 minutes, the proportions of working time, non-working time, and disinfection time of the endoscopy operating room during the weekday are calculated. Based on these proportions, the working time of the endoscopy operating room within the minimum unit usage period c is calculated as follows: Non-working time And disinfection time z.

[0013] Preferably, a salt spray test chamber is used to conduct hydrogen peroxide spray tests to simulate the effects of chemical disinfection and residue. The chemical disinfection time for the endoscope operating section is accelerated in the salt spray test chamber according to the principle of equal total chemical spray volume and compressed chemical spray time. Glutaraldehyde, phthalaldehyde, or hydrogen peroxide can be selected as the chemical agent. This scheme uses hydrogen peroxide as an example for the test. Alternatively, a standard concentration of glutaraldehyde or phthalaldehyde solution can be prepared and sprayed in the salt spray test chamber. The distribution density of the hydrogen peroxide disinfectant is 4 mL of solution per 60 L of chamber volume. The chemical disinfectant solution is sprayed in the salt spray test chamber at an environment of 45℃-55℃, with a spray pressure of 0.1 MPa. The salt spray test can realistically reflect the corrosive effect of disinfection on the endoscope operating section during actual use.

[0014] To calculate the deposition rate of hydrogen peroxide spray during the experiment, it is necessary to convert the data based on the volume of the endoscope's operating section. The conversion method is as follows:

[0015] Based on the dimensions of the operating unit, the beam guide, and the light guide plug, the volumes of each component are calculated, with the volume of the operating unit being... The volume of the beam guide is The volume of the light guide plug is The total volume of the test sample in the endoscope operating section. for:

[0016]

[0017] The amount of hydrogen peroxide solution that settles in a sample uniformly during a single vacuum sterilization process. for:

[0018]

[0019] Number of vacuum sterilization cycles during the service life a for

[0020]

[0021] Where z is the disinfection duration in the minimum unit of use period c; It is a multiple of the smallest unit of service life c in service life a.

[0022] The total sedimentation amount of hydrogen peroxide solution during the simulated service life a is Q2:

[0023]

[0024] The simulated hydrogen peroxide solution disinfection test was conducted in a salt spray chamber. The sedimentation rate of the salt spray chamber was set based on the spray volume per unit time and unit cross-sectional area, with the unit time being 1 hour and the unit cross-sectional area being 80 cm². Therefore, a unified conversion based on the cross-sectional areas of the operating section, beam guide, and light guide plug is necessary. The cross-sectional area of ​​the operating section is... The cross-sectional area of ​​the beam guide is The cross-sectional area of ​​the light guide plug is The total cross-sectional area of ​​the test sample in the endoscope operating section. for:

[0025]

[0026] Adjust the sedimentation value Q of the salt spray test chamber, and set the single disinfection time t to 0.25 hours. Then, use the salt spray chamber test to simulate the sedimentation of hydrogen peroxide solution in a single test of 0.25 hours. for:

[0027]

[0028] Under the same operating temperature and hydrogen peroxide solution concentration, the test time required to disinfect the same amount of deposits on each working day of each quarter was simulated. for:

[0029]

[0030] Following the salt spray test, a plasma disinfection test was added to simulate the impact of plasma disinfection on the service life of the endoscope operating part under real-world conditions. The plasma disinfection test lasted 0.75 hours. Adding a full-process low-temperature hydrogen peroxide plasma disinfection process allows for consideration of the impact of the disinfection plasma effect on the endoscope operating part. After adjusting the test time, the simulation time for each year's disinfection process is [not specified]. for:

[0031]

[0032] Preferably, according to GB / T 34986-2017 "Accelerated Testing Methods for Products", the acceleration model for high-temperature accelerated testing is selected as the Arrhenius model, and the acceleration model is as follows:

[0033]

[0034] in, In order to be in Degradation rate under temperature stress level; The acceleration stress of the first-stage sample is given by absolute temperature, in units of... A is the frequency factor; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10-5 eV / K.

[0035] The experimental acceleration factor AF can be calculated using the Arrhenius model. The formula for calculating the experimental acceleration factor AF is as follows:

[0036]

[0037] in, The accelerating stress of the sample under working conditions is given by absolute temperature, in units of... ; The accelerated stress of the sample at high temperature, in absolute temperature, is expressed in units of... ; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10-5 eV / K.

[0038] Considering that the materials used in the endoscope operating part are 304 stainless steel, PP, silicone, PVC and aluminum alloy, the acceleration temperature is selected as 70℃ in order not to change the failure mechanism of the materials.

[0039] During the high-temperature accelerated simulation of working day conditions, the temperature of the endoscope's operating section during operation was 30℃, where... , The acceleration coefficient of the high-temperature accelerated simulation of working day conditions test for:

[0040]

[0041] During high-temperature accelerated simulation tests simulating both working and non-working conditions, the temperature of the endoscope's operating section in the working state is 25°C, where... , The acceleration coefficient of the high-temperature accelerated simulation test under non-working conditions on a weekday. for:

[0042]

[0043] Acceleration factor of high-temperature accelerated simulation of non-working day test for:

[0044]

[0045] The endoscopy examination time and non-working time of the endoscopy operation department were verified by high-temperature accelerated testing. The endoscopy examination time is 3 hours per workday, calculated as 62.5 workdays per quarter; the non-working time is 16.5 hours per workday, calculated as 62.5 workdays per quarter; and the non-working days are 28.75 days per quarter, all of which are non-working time.

[0046] Test time required for high-temperature accelerated simulation of daily working conditions for:

[0047]

[0048] Test time required for high-temperature accelerated simulation of non-working conditions on a weekday for:

[0049]

[0050] Test time required for high temperature accelerated simulation non-working day test for:

[0051]

[0052] Because the Arrhenius model used in high-temperature accelerated testing is relatively mature, the engineering coefficient for high-temperature accelerated testing is... A value of 1.0 can be taken. In summary, the simulated endoscope operating section underwent accelerated testing at 70℃ in the first quarter. for:

[0053]

[0054] The above calculations show that when calculating the high-temperature accelerated test time, the result is only related to the test temperature and is not related to the specific composition or size of the endoscope operating part.

[0055] Preferably, in step 5, the endoscope performance index is the light source illuminance. Since endoscope testing primarily focuses on control function indicators, such as button effectiveness, water / air supply, and image operation, the only quantifiable performance indicators are light source illuminance and actuator stroke. However, the actuator stroke test accuracy is uncontrollable, and it remains within the 42mm–43mm range during accelerated life testing, making comparisons less meaningful. The illuminance index of the endoscope's operating section is easy to measure and changes significantly during accelerated life testing. Therefore, the illuminance index is used for comparison.

[0056] Compared to existing technologies, this solution divides the experimental profile into three segments: accelerated high-temperature testing during non-operating processes, accelerated high-temperature testing during endoscopic examination, and accelerated testing during chemical disinfection. Furthermore, to better simulate the actual use of the endoscope operating unit, this design incorporates a cyclical testing approach for evaluating the endoscope operating unit's lifespan, with each cycle verifying a quarter's worth of service life. This invention, through a testing method combining "accelerated high-temperature aging + accelerated chemical disinfection," fully simulates the aging process of the endoscope operating unit during actual use and specifically conducts accelerated testing, thus solving the problem of lifespan assessment and providing a basis for medical device registration. Attached Figure Description

[0057] Figure 1 This is a flowchart of a method for evaluating the service life of an endoscope operating unit according to the present invention.

[0058] Figure 2 This is a schematic diagram of the stress profile of a single-cycle test of an endoscope operating part in a method for evaluating the service life of an endoscope operating part according to the present invention.

[0059] Figure 3 This is a comparison chart of the illumination index of a sample from an equivalent 2-year accelerated life test and a sample from normal 2-year use, in an endoscope operating section service life evaluation method of the present invention. Detailed Implementation

[0060] The accompanying drawings are for illustrative purposes only and should not be construed as limiting this patent. To better illustrate this embodiment, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual product dimensions. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings. The positional relationships described in the drawings are for illustrative purposes only and should not be construed as limiting this patent.

[0061] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar parts. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," "long," and "short" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0062] The technical solution of the present invention will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings:

[0063] Example 1

[0064] like Figure 1 The following is an embodiment of a method for evaluating the service life of an endoscope operating section, comprising the following steps:

[0065] Step 1: Conduct a high-temperature accelerated test to simulate the working conditions of a normal workday, based on the set service life 'a'.

[0066] Step 2: Conduct a high-temperature accelerated test to simulate a non-working state during a workday, based on the set service life 'a'.

[0067] Step 3: Conduct a high-temperature accelerated test to simulate a non-working day test, based on the set service life 'a'.

[0068] Step 4: Conduct a hydrogen peroxide spray test to simulate the effects of chemical disinfection and residues, based on the set service life 'a'.

[0069] Step 5: Based on the required verification time b for the test subject, repeat steps 1 to 4 until the verification time b is met, then end the loop and verify the performance indicators of the endoscope operating unit. The verification time b is m times the service life a, where m is an integer.

[0070] Specifically, when evaluating the service life of the endoscope operating unit, if a quarter is used as the calculation method, then... =91.25. Based on the ratio of working days to non-working days in a year, the minimum unit usage period c is calculated, with working day duration e being 16.44 hours and non-working day duration... The time allotted is 7.56 hours. Based on 6 work cycles per weekday for the endoscopy operating room, an average routine endoscopy procedure takes approximately 30 minutes, and a complete disinfection time is approximately 45 minutes. Therefore, the ratio of working time, non-working time, and disinfection time for the endoscopy operating room on a weekday is calculated to be 3:4.5:16.5. Based on this ratio, the working time of the endoscopy operating room within the minimum unit usage period c is calculated as follows: The duration of non-working status is 2.06 hours. The disinfection time is 11.3 hours, and the disinfection duration is 3.08 hours.

[0071] The beneficial effects of this embodiment are as follows: The experimental profile of this scheme is divided into three segments: accelerated high-temperature testing during non-working processes, accelerated high-temperature testing during endoscopic examination, and accelerated testing during chemical disinfection. Furthermore, to better simulate the actual use of the endoscope operating unit, this experimental design for evaluating the service life of the endoscope operating unit is cyclical, with each cycle verifying the service life for one quarter. This invention, through the experimental method of "accelerated high-temperature aging + accelerated chemical disinfection," fully simulates the aging process of the endoscope operating unit during actual use and conducts targeted accelerated testing, solving the problem of service life assessment and providing a basis for medical device registration.

[0072] Example 2

[0073] Example 2 of a method for evaluating the service life of an endoscope operating section, such as... Figures 2-3 As shown, based on Example 1, steps 4 to 5 are further defined.

[0074] Specifically, a salt spray chamber was used to conduct hydrogen peroxide spray tests to simulate the effects of chemical disinfection and residues. The chemical disinfection time for the endoscope operating section was accelerated in the salt spray chamber according to the principle of equal total chemical spray volume and compressed chemical spraying time. Hydrogen peroxide was used as an example in this test. The distribution density of the hydrogen peroxide disinfectant was 4 mL solution per 60 L chamber volume. The chemical disinfectant solution was sprayed in the salt spray chamber at an temperature of 45℃-55℃, with a spray pressure of 0.1 MPa.

[0075] To calculate the deposition rate of hydrogen peroxide spray during the experiment, it is necessary to convert the data based on the volume of the endoscope's operating section. The conversion method is as follows:

[0076] Based on the dimensions of the operating unit, the beam guide, and the light guide plug, the volumes of each component are calculated, with the volume of the operating unit being... The volume of the beam guide is The volume of the light guide plug is The total volume of the test sample in the endoscope operating section. for:

[0077]

[0078] The amount of hydrogen peroxide solution that settles in a sample uniformly during a single vacuum sterilization process. for:

[0079]

[0080] Number of vacuum sterilization cycles during the service life a for

[0081]

[0082] The total sedimentation amount of hydrogen peroxide solution after 375 disinfections within each quarter's usage period, simulated as Q2, is:

[0083]

[0084] The simulated hydrogen peroxide solution disinfection test was conducted in a salt spray chamber. The sedimentation rate of the salt spray chamber is set based on the spray volume per unit time and unit cross-sectional area. In this scheme, the unit time is 1 hour, and the unit cross-sectional area is 80 cm². Therefore, a unified conversion is needed based on the cross-sectional areas of the operating section, the beam guide, and the light guide plug. The cross-sectional area of ​​the operating section is... The cross-sectional area of ​​the beam guide is The cross-sectional area of ​​the light guide plug is The total cross-sectional area of ​​the test sample in the endoscope operating section. for:

[0085]

[0086] Adjust the sedimentation rate Q of the salt spray test chamber, and set the single disinfection time t to 15 min. Then, use the salt spray chamber test to simulate the sedimentation rate of hydrogen peroxide solution in a single 15 min test. for:

[0087]

[0088] Under the same operating temperature and hydrogen peroxide solution concentration, the test time required to disinfect the same amount of deposits on each working day of each quarter was simulated. for:

[0089]

[0090] Following the salt spray test, a plasma disinfection test was added to simulate the impact of plasma disinfection on the service life of the endoscope operating part under real-world conditions. The plasma disinfection test lasted 45 minutes. Adding a full-process low-temperature hydrogen peroxide plasma disinfection process allows for consideration of the impact of the disinfection plasma effect on the endoscope operating part. After adjusting the test time, the simulation time for each year's disinfection process was [calculated / adjusted]. for:

[0091]

[0092] Specifically, in step 5, the endoscope performance index is the light source illuminance.

[0093] The beneficial effects of this embodiment are: the salt spray test can accurately reflect the corrosive effect of disinfection on the endoscope operating section during actual use; the illuminance index of the endoscope operating section is easy to measure and changes significantly during accelerated life testing.

[0094] Example 3

[0095] Example 3 of a method for evaluating the service life of an endoscope operating section, such as... Figures 2-3 As shown, based on Examples 1 and 2, steps 1 to 3 are further defined.

[0096] Specifically, according to GB / T 34986-2017 "Accelerated Testing Methods for Products", the Arrhenius model is selected as the acceleration model for high-temperature accelerated testing. The acceleration model is as follows:

[0097]

[0098] in, In order to be in Degradation rate under temperature stress level; The acceleration stress of the first-stage sample is given by absolute temperature, in units of... A is the frequency factor; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10-5 eV / K.

[0099] The experimental acceleration factor AF can be calculated using the Arrhenius model. The formula for calculating the experimental acceleration factor AF is as follows:

[0100]

[0101] in, The accelerating stress of the sample under working conditions is given by absolute temperature, in units of... ; The accelerated stress of the sample at high temperature, in absolute temperature, is expressed in units of... ; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10-5 eV / K.

[0102] Considering that the materials used in the endoscope operating part are 304 stainless steel, PP, silicone, PVC and aluminum alloy, the acceleration temperature is selected as 70℃ in order not to change the failure mechanism of the materials.

[0103] During the high-temperature accelerated simulation of working day conditions, the temperature of the endoscope's operating section during operation was 30℃, where... , The acceleration coefficient of the high-temperature accelerated simulation of working day conditions test for:

[0104]

[0105] During high-temperature accelerated simulation tests simulating both working and non-working conditions, the temperature of the endoscope's operating section in the working state is 25°C, where... , The acceleration coefficient of the high-temperature accelerated simulation test under non-working conditions on a weekday. for:

[0106]

[0107] Acceleration factor of high-temperature accelerated simulation of non-working day test for:

[0108]

[0109] The endoscopy examination time and non-working time of the endoscopy operation department were verified by high-temperature accelerated testing. The endoscopy examination time is 3 hours per workday, calculated as 62.5 workdays per quarter; the non-working time is 16.5 hours per workday, calculated as 62.5 workdays per quarter; and the non-working days are 28.75 days per quarter, all of which are non-working time.

[0110] Test time required for high-temperature accelerated simulation of daily working conditions for:

[0111]

[0112] Test time required for high-temperature accelerated simulation of non-working conditions on a weekday for:

[0113]

[0114] Test time required for high temperature accelerated simulation non-working day test for:

[0115]

[0116] Because the Arrhenius model used in high-temperature accelerated testing is relatively mature, the engineering coefficient for high-temperature accelerated testing is... A value of 1.0 can be taken. In summary, the simulated endoscope operating section underwent accelerated testing at 70℃ in the first quarter. for:

[0117] ( )

[0118] The beneficial effects of this embodiment are: the high-temperature accelerated test can accurately simulate the aging of the endoscope operating part under normal use conditions, and when calculating the high-temperature accelerated test time, the result is only related to the test temperature and is not related to the specific composition and size of the endoscope operating part.

[0119] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A method for evaluating the service life of an endoscope operating section, characterized in that, Includes the following steps: Step 1: Conduct a high-temperature accelerated test to simulate the working conditions of a normal workday, based on the set service life 'a'. Step 2: Conduct a high-temperature accelerated test to simulate a non-working state during a workday, based on the set service life 'a'. Step 3: Conduct a high-temperature accelerated test to simulate a non-working day test, based on the set service life 'a'. Step 4: Conduct a hydrogen peroxide spray test to simulate the effects of chemical disinfection and residues, based on the set service life 'a'. Step 5: Based on the required verification time b for the test subject, repeat steps 1 to 4 until the verification time b is met, then end the loop and verify the performance indicators of the endoscope operating part. The verification time b is m times the service life a, where m is an integer. When evaluating the service life of the endoscopy operating unit, the smallest unit of service life 'a' is 'c', where 'c' is one day. Service life 'a' is n times the smallest unit of service life 'c'. The length of working days 'e' and the length of non-working days 'f' in the smallest unit of service life 'c' are calculated based on the ratio of working days to non-working days in a year. Assuming that the endoscopy operating unit is used 6 times a day on a workday, and that an average routine endoscopy examination takes about 30 minutes and a complete disinfection time takes about 45 minutes, the proportions of working time, non-working time, and disinfection time of the endoscopy operating unit on a workday are calculated. The working time (x), non-working time (y), and disinfection time (z) of the endoscope operation department are calculated based on the ratio of the working time, non-working time, and disinfection time of the endoscope operation department during a workday. The working time (x), non-working time (y), and disinfection time (z) of the endoscope operation department are calculated within the working time (e) of the minimum unit service period (c). In the minimum unit usage period c, the units for working day duration e, non-working day duration f, and the working state duration x, non-working state duration y, and disinfection duration z of the endoscope operating unit in the working day duration e of the minimum unit usage period c are all hours.

2. The method for evaluating the service life of an endoscope operating unit according to claim 1, characterized in that, In step 4, a hydrogen peroxide spray test is conducted using a salt spray test chamber to simulate the effects of chemical disinfection and residues, and the required test time is calculated based on the test conditions.

3. The method for evaluating the service life of an endoscope operating unit according to claim 2, characterized in that, In step 4, the salt spray test chamber sprays a chemical disinfectant solution at an environment of 45℃-55℃ and a spray pressure of 0.1 MPa.

4. The method for evaluating the service life of an endoscope operating unit according to claim 2, characterized in that, Step 4 also includes a plasma disinfection test, which is conducted after the salt spray test and lasts for 0.75 hours.

5. The method for evaluating the service life of an endoscope operating unit according to claim 1, characterized in that, When conducting high-temperature accelerated testing, the Arrhenius acceleration model is used to calculate the acceleration coefficient and test duration. The acceleration model is as follows: in, In order to be in Degradation rate under temperature stress level; The acceleration stress of the sample in stage l is given by absolute temperature, in units of... A is the frequency factor; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10⁻⁵ eV / K; The experimental acceleration factor AF can be calculated using the Arrhenius model. The formula for calculating the experimental acceleration factor AF is as follows: in, The accelerating stress of the sample under working conditions is given by absolute temperature, in units of... ; The accelerated stress of the sample at high temperature, in absolute temperature, is expressed in units of... ; The activation energy is expressed in eV. Since the endoscope operating part involves multiple materials and is classified as a medical electronic device, the empirical value of 0.6 eV for medical electronic devices is used here. Boltzmann's constant, =8.6174×10-5 eV / K.

6. The method for evaluating the service life of an endoscope operating unit according to claim 5, characterized in that, In step 1, when conducting the high-temperature accelerated simulation of a working day's operating conditions test, the required test time for the high-temperature accelerated simulation of a working day's operating conditions test is calculated based on the test acceleration factor AF. The calculation formula is: in, It is the acceleration factor for high-temperature accelerated simulation of working conditions on a normal working day; It is the working status duration in the minimum unit of service life c; It is a multiple of the smallest unit of usage period c in usage period a.

7. The method for evaluating the service life of an endoscope operating unit according to claim 5, characterized in that, In step 2, when conducting the high-temperature accelerated simulation of non-working conditions on a workday, the required test time for the high-temperature accelerated simulation of working conditions on a workday is calculated based on the test acceleration factor AF. The calculation formula is: in, It is the acceleration factor for high-temperature accelerated simulation of non-working conditions during a workday. It is the non-working time during working days in the minimum unit of usage period c; It is a multiple of the smallest unit of usage period c in usage period a.

8. The method for evaluating the service life of an endoscope operating unit according to claim 5, characterized in that, In step 3, when conducting the high-temperature accelerated simulation non-working day test, the test time required for the high-temperature accelerated simulation working day test is calculated based on the test acceleration coefficient AF. The calculation formula is: in, It is the acceleration factor for high-temperature accelerated simulation of non-working days; It refers to the non-working day duration within the minimum unit of usage period c; It is a multiple of the smallest unit of usage period c in usage period a.

9. The method for evaluating the service life of an endoscope operating unit according to claim 1, characterized in that, In step 5, the endoscope performance index is the light source illuminance.

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