Medical instrument package detection method, device, equipment and storage medium

By acquiring images of the pressure points and surface samples of medical device packaging, and using image processing technology to determine the packaging and sterilization status, the problem of low detection efficiency in existing technologies is solved, achieving efficient and accurate packaging detection.

CN115731182BActive Publication Date: 2026-07-31GUORUI ZHONGAN MEDICAL TECH (SHENZHEN) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
GUORUI ZHONGAN MEDICAL TECH (SHENZHEN) CO LTD
Filing Date
2022-11-21
Publication Date
2026-07-31

AI Technical Summary

Technical Problem

Existing technologies for medical device packaging testing are inefficient and prone to omissions, making it impossible to efficiently detect whether packaging requirements are met.

Method used

By acquiring images of the pressure points and surface samples of the packaging of the instruments to be tested, image processing technology is used to determine the packaging and sterilization status, and finally, the test results are determined.

Benefits of technology

This improves the efficiency and accuracy of packaging inspection, ensuring that medical device packaging meets factory requirements.

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Abstract

This invention belongs to the field of image detection technology and discloses a method, apparatus, device, and storage medium for detecting medical device packaging. The method includes: acquiring a pressed image and surface sample information of the packaging of the medical device to be tested; determining the packaging state of the packaging based on the pressed image; determining the disinfection state of the packaging based on the surface sample information; and determining the detection result of the packaging based on the packaging state and the disinfection state. By acquiring a pressed image and surface sample of the packaging of the medical device to be tested, determining the packaging state based on the pressed image, determining the disinfection state based on the surface sample information, determining the detection result based on the disinfection state and the packaging state, and determining whether the packaging meets the packaging requirements based on the detection result, this method not only improves the efficiency of packaging detection but also ensures its accuracy.
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Description

Technical Field

[0001] This invention relates to the field of image inspection technology, and in particular to a method, apparatus, equipment and storage medium for inspecting medical device packaging. Background Technology

[0002] Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are used directly or indirectly on the human body, including the necessary computer software. Medical devices include medical equipment and medical consumables. Due to the special nature of medical devices, their packaging requires strict adherence to medical device packaging requirements and undergoes rigorous factory testing before leaving the factory. However, current technology often relies on manual screening of packaging, which is not only inefficient but also prone to omissions. Summary of the Invention

[0003] The main objective of this invention is to provide a method, apparatus, equipment, and storage medium for testing medical device packaging, aiming to solve the technical problem that existing technologies cannot efficiently detect whether medical device packaging meets packaging requirements.

[0004] To achieve the above objectives, the present invention provides a method for testing medical device packaging, the method comprising:

[0005] Acquire images of the packaging of the instrument to be tested and information on the surface samples collected;

[0006] The packaging status of the device to be tested is determined based on the pressing image;

[0007] The disinfection status of the packaging of the instrument to be tested is determined based on the information collected from the surface.

[0008] The test results of the packaging of the instrument to be tested are determined based on the packaging status and the disinfection status.

[0009] Optionally, determining the packaging state of the device to be tested based on the pressing image includes:

[0010] The device outline of the instrument to be tested is determined based on the pressing image;

[0011] The coordinate position of the packaging of the instrument to be tested is determined based on the instrument outline.

[0012] The packaging status of the instrument to be tested is determined based on the coordinate position.

[0013] Optionally, determining the device contour of the device to be detected based on the pressing image includes:

[0014] The pressed image is preprocessed to obtain a processed detection image;

[0015] The image segmentation threshold is determined based on the processed and detected image;

[0016] The processed detection image is segmented according to the image segmentation threshold to obtain the device outline of the device to be detected.

[0017] Optionally, determining the image segmentation threshold based on the processed and detected image includes:

[0018] Based on the processed and detected image, determine the image grayscale level, preset feature parameters, and initial threshold;

[0019] The joint probability density of the preset feature parameters is determined based on the image grayscale levels;

[0020] The target contour region and background packaging region are determined based on the initial threshold and the processed detection image;

[0021] The first probability density of the target contour region is determined based on the initial threshold and the joint density probability.

[0022] The second probability density of the background packaging region is determined based on the image grayscale level and the joint density probability.

[0023] The image segmentation threshold is determined based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level.

[0024] Optionally, determining the image segmentation threshold based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial threshold, and the image grayscale level includes:

[0025] The first mean value and the second mean value are determined based on the preset feature parameters, the joint probability density, the first probability density, and the initial set threshold.

[0026] The third mean value and the fourth mean value are determined based on the preset feature parameters, the joint probability density, the second probability density, the initial set threshold, and the image gray level.

[0027] The image segmentation threshold is determined based on the first mean value, the second mean value, the third mean value, the fourth mean value, the preset feature parameter, the initial set threshold, and the image grayscale level.

[0028] Optionally, determining the packaging state of the device to be tested based on the coordinate position includes:

[0029] The error distance of the packaging of the instrument to be tested is determined based on the coordinate position and the preset comparison position;

[0030] The packaging comparison result of the device to be tested is determined based on the error distance and the preset error range;

[0031] The packaging condition of the instrument to be tested is determined based on the packaging comparison results.

[0032] Optionally, after determining the test result of the packaging of the instrument to be tested based on the packaging state and the disinfection state, the method further includes:

[0033] When the test result of the packaging of the instrument to be tested is unqualified, the packaging identifier of the packaging of the instrument to be tested is obtained;

[0034] A defect detection table is established based on the packaging identifier and the detection results;

[0035] Packaging filtering is performed based on the aforementioned defect detection table, and a defect statistics table is determined.

[0036] Send the defect statistics table to the administrator to alert them of packaging defects.

[0037] Furthermore, to achieve the above objectives, the present invention also provides a medical device packaging testing device, the medical device packaging testing device comprising:

[0038] The acquisition module is used to acquire images of the pressure points and surface samples of the packaging of the instrument to be tested.

[0039] A determining module is used to determine the packaging status of the device to be tested based on the pressing image;

[0040] The determining module is also used to determine the disinfection status of the packaging of the instrument to be tested based on the surface sample information;

[0041] The determining module is further configured to determine the test result of the packaging of the instrument to be tested based on the packaging status and the disinfection status.

[0042] Furthermore, to achieve the above objectives, the present invention also proposes a medical device packaging testing device, which includes: a memory, a processor, and a medical device packaging testing program stored in the memory and executable on the processor, wherein the medical device packaging testing program is configured to implement the medical device packaging testing method described above.

[0043] In addition, to achieve the above objectives, the present invention also proposes a storage medium storing a medical device packaging inspection program, which, when executed by a processor, implements the medical device packaging inspection method as described above.

[0044] This invention acquires a pressed image and surface sample information of the packaging of a medical device to be tested; determines the packaging state of the packaging based on the pressed image; determines the disinfection state of the packaging based on the surface sample information; and determines the test result of the packaging based on the packaging state and the disinfection state. Through this method, the invention acquires a pressed image and surface sample of the packaging of a medical device to be tested, determines the packaging state based on the pressed image to determine if the packaging is damaged, determines the disinfection state based on the surface sample information to determine if the packaging was properly disinfected before leaving the factory, and finally determines the test result of the packaging based on the disinfection state and the packaging state. Based on the test result, it determines whether the packaging meets the packaging requirements, thus improving the efficiency and ensuring the accuracy of packaging testing. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of the structure of a medical device packaging testing equipment in the hardware operating environment involved in the embodiments of the present invention;

[0046] Figure 2 This is a flowchart illustrating the first embodiment of the medical device packaging testing method of the present invention;

[0047] Figure 3 This is a flowchart illustrating the second embodiment of the medical device packaging testing method of the present invention;

[0048] Figure 4 This is a structural block diagram of the first embodiment of the medical device packaging testing device of the present invention.

[0049] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0050] It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0051] Reference Figure 1 , Figure 1 This is a schematic diagram of the structure of a medical device packaging testing equipment in the hardware operating environment of an embodiment of the present invention.

[0052] like Figure 1As shown, the medical device packaging testing equipment may include: a processor 1001, such as a central processing unit (CPU), a communication bus 1002, a user interface 1003, a network interface 1004, and a memory 1005. The communication bus 1002 is used to enable communication between these components. The user interface 1003 may include a display screen and an input unit such as a keyboard; optionally, the user interface 1003 may also include a standard wired interface or a wireless interface. The network interface 1004 may optionally include a standard wired interface or a wireless interface (such as a Wireless-Fidelity (Wi-Fi) interface). The memory 1005 may be a high-speed random access memory (RAM) or a stable non-volatile memory (NVM), such as a disk drive. The memory 1005 may also optionally be a storage device independent of the aforementioned processor 1001.

[0053] Those skilled in the art will understand that Figure 1 The structure shown does not constitute a limitation on medical device packaging testing equipment and may include more or fewer components than shown, or combine certain components, or have different component arrangements.

[0054] like Figure 1 As shown, the memory 1005, which serves as a storage medium, may include an operating system, a network communication module, a user interface module, and a medical device packaging testing program.

[0055] exist Figure 1 In the medical device packaging testing equipment shown, the network interface 1004 is mainly used for data communication with the network server; the user interface 1003 is mainly used for data interaction with the user; the processor 1001 and the memory 1005 in the medical device packaging testing equipment of the present invention can be set in the medical device packaging testing equipment. The medical device packaging testing equipment calls the medical device packaging testing program stored in the memory 1005 through the processor 1001 and executes the medical device packaging testing method provided in the embodiment of the present invention.

[0056] This invention provides a method for testing medical device packaging, referring to... Figure 2 , Figure 2 This is a flowchart illustrating the first embodiment of a medical device packaging testing method according to the present invention.

[0057] The testing methods for medical device packaging include the following steps:

[0058] Step S10: Obtain the pressed image and surface sample information of the packaging of the instrument to be tested.

[0059] It should be noted that the execution subject in this embodiment is the controller of the medical device packaging inspection system. The controller can be a smart terminal device. The medical device packaging inspection system includes a controller, an image acquisition module, a packaging pressing module, a colony collection module, and a filtering module. The controller acquires the pressing image and surface collection information of the packaging of the device to be inspected, determines the packaging status of the packaging of the device to be inspected based on the pressing image, determines the disinfection status of the packaging of the device to be inspected based on the surface collection information, and determines the inspection result of the packaging of the device to be inspected based on the packaging status and the disinfection status.

[0060] Understandably, the packaging of the medical device under test refers to the sealed bag containing the medical device. After the testing of the packaging begins, the controller sends a pressing command to the packaging pressing module. The packaging pressing module then activates the heating device to raise the temperature. During this process, the standard storage temperature range of the medical device under test and the deformation temperature range of the packaging are obtained. The target heating temperature is determined based on the upper limit of the standard storage temperature range and the lower limit of the deformation temperature range to ensure the usability of the medical device under test and the integrity of the packaging. At this point, the packaging will undergo slight deformation. The packaging pressing module then activates the pressing device to press the center of the packaging. When the pressing device contacts the packaging of the instrument to be tested, it sends an image acquisition command to the image acquisition module. The image acquisition module acquires an image of the packaging when it is pressed and sends the image to the controller. At the same time, when the testing of the packaging begins, the controller issues an acquisition command to the colony collection module. The colony collection module collects microorganisms on the surface of the packaging according to the preset microbial collection steps, thereby obtaining the microbial substances present on the surface of the packaging. The colony collection module culture and counts the microorganisms present on the surface of the packaging and generates a microbial statistics table based on the culture results.

[0061] In practice, the image of the device packaging being pressed after heating, captured by the image acquisition module, is the pressing image, and the microbial statistics table sent by the colony acquisition module to the controller is the surface collection information.

[0062] Step S20: Determine the packaging status of the device to be tested based on the pressing image.

[0063] It should be noted that after the controller acquires the pressed image of the surface of the packaging of the device to be tested, it can determine the packaging status of the packaging of the device to be tested based on the coordinate position of each marker point of the packaging in the pressed image. The packaging status is divided into damaged status and intact status.

[0064] Step S30: Determine the disinfection status of the packaging of the instrument to be tested based on the surface sample information.

[0065] It should be noted that after receiving the surface sample information, the controller compares it with a preset standard colony table to determine whether there are microbial contamination issues on the surface of the device packaging to be tested. Based on the presence of microbial contamination, the controller determines the disinfection status of the device packaging, which is categorized as either acceptable or unacceptable. For example, in the surface sample information, substance 1 corresponds to a quantity of 2 × 10⁻⁶. 3 cfu / mL, the corresponding quantity of substance 2 is 0.5 × 10⁻⁶. 3 cfu / mL, the quantity corresponding to substance 1 in the pre-defined standard colony table is 0~1×10⁻⁶. 3 cfu / mL, the corresponding quantity of substance 2 is 0~1.2×10 3 If the concentration of cfu / mL is too high, it indicates that substance 2 on the surface of the packaging of the instrument being tested exceeds the standard, and the disinfection status of the packaging of the instrument being tested is unqualified.

[0066] Step S40: Determine the test result of the packaging of the instrument to be tested based on the packaging status and the disinfection status.

[0067] It should be noted that after obtaining the packaging and disinfection status of the device to be tested, the controller can determine the test result. If either the packaging or disinfection status fails to meet the requirements, the test result is unqualified. For example, if the packaging is intact but the disinfection status is unqualified, the test result is that the packaging is intact but the disinfection is inadequate, and the device to be tested is unqualified.

[0068] Understandably, to ensure that administrators can promptly identify problems based on test results, guarantee that medical device packaging meets requirements, and conserve resources, the method further includes, after determining the test result of the device packaging based on the packaging status and disinfection status, the following steps are also included: when the test result of the device packaging is unqualified, obtaining the packaging identifier of the device packaging; establishing a test defect table based on the packaging identifier and the test result; filtering packaging based on the test defect table and determining a defect statistics table; and sending the defect statistics table to the administrator as a packaging defect reminder.

[0069] In practice, when the testing of a device begins, the controller obtains the packaging code of that device packaging. Each device packaging has a unique packaging code, which serves as the packaging identifier.

[0070] It should be noted that the controller acquires the packaging identifiers and corresponding test results of the defective medical device packaging. Based on the test results and packaging identifiers, it establishes a defect table and sends the defect table and filtering instructions to the filtering module. The filtering module then filters out the medical device packaging in the defect table according to the filtering instructions. Simultaneously, the controller performs defect statistics based on the defect table, determining the number of medical device packaging in the same batch that is in a damaged state and the number that is in a non-compliant disinfection state. A defect statistics table is then established and sent to the administrator as a reminder, enabling the administrator to rectify the defects promptly.

[0071] This embodiment acquires a pressing image and surface sample information of the packaging of the device to be tested; determines the packaging state of the packaging based on the pressing image; determines the disinfection state of the packaging based on the surface sample information; and determines the test result of the packaging based on the packaging state and the disinfection state. Through this method, pressing images and surface samples of the packaging of the device to be tested are acquired; the packaging state is determined based on the pressing image, thereby determining whether the packaging is damaged; the disinfection state is determined based on the surface sample information, thereby determining whether the packaging was properly disinfected before leaving the factory; and finally, the test result is determined based on the disinfection state and the packaging state. Based on the test result, it is determined whether the packaging meets the packaging requirements. This not only improves the efficiency of packaging testing but also ensures its accuracy.

[0072] refer to Figure 3 , Figure 3 This is a flowchart illustrating a second embodiment of a medical device packaging testing method according to the present invention.

[0073] Based on the first embodiment described above, step S20 in the medical device packaging testing method of this embodiment includes:

[0074] Step S21: Determine the device outline of the device to be tested based on the pressing image.

[0075] It should be noted that when the packaging pressing module presses the packaging of the instrument to be tested, the outline of the instrument to be tested will be displayed on the surface of the packaging. The outline of the instrument to be tested is obtained based on the collected pressing image, and the outline of the instrument to be tested is the instrument outline.

[0076] Understandably, in order to obtain an accurate device contour based on the pressure image, the step of determining the device contour of the device to be tested based on the pressure image further includes: preprocessing the pressure image to obtain a processed detection image; determining an image segmentation threshold based on the processed detection image; and segmenting the processed detection image based on the image segmentation threshold to obtain the device contour of the device to be tested.

[0077] In practice, preprocessing includes converting the pressed image to grayscale, enhancing the image, filtering, and binarizing it to overcome image interference. The image obtained after preprocessing is the processed detection image.

[0078] It should be noted that the image segmentation threshold is a segmentation threshold used to distinguish between the instrument outline and the boundary line of the packaging of the instrument to be inspected. By segmenting the processed inspection image based on the image segmentation threshold, the instrument outline of the instrument to be inspected can be obtained.

[0079] It is understood that, in order to obtain an accurate image segmentation threshold based on the processed detection image, the step of determining the image segmentation threshold based on the processed detection image further includes: determining the image grayscale level, preset feature parameters, and an initial threshold based on the processed detection image; determining the joint probability density of the preset feature parameters based on the image grayscale level; determining the target contour region and the background packaging region based on the initial threshold and the processed detection image; determining the first probability density of the target contour region based on the initial threshold and the joint probability density; determining the second probability density of the background packaging region based on the image grayscale level and the joint probability density; and determining the image segmentation threshold based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial threshold, and the image grayscale level.

[0080] In the specific implementation, the image grayscale level refers to the grayscale level A of the processed detection image, and the preset feature parameters refer to the pre-set binary parameters (m, n), where m is the grayscale feature of the pixel, and n is the correlation statistical feature obtained based on neighborhood information. A threshold is set for the processed detection image, i.e., the initial threshold (p, q), where p is the threshold for segmenting m in the processed detection image, and q is the threshold for segmenting n in the processed detection image. The joint probability density F corresponding to the preset feature parameters can be determined based on the image grayscale level, where... A gray-level probability space is defined in the processed detection image. Based on an initially set threshold, the gray-level probability space is divided to perform preliminary region segmentation of the processed detection image, obtaining the target contour region and the background packaging region. The target contour region and the background packaging region are quite different. The joint probability density corresponding to the target contour region of the processed detection image is calculated. The joint probability density of the background packaging area is The first joint density is the joint probability density corresponding to the target contour region, and the second joint density is the joint probability density of the background packaging region. The image segmentation threshold can be determined based on the preset feature parameters, joint probability density, first probability density, second probability density, initial threshold, and image grayscale level.

[0081] It should be noted that, in order to determine an accurate image segmentation threshold based on the above parameters, the step of determining the image segmentation threshold according to the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial threshold, and the image grayscale level further includes: determining a first mean value and a second mean value according to the preset feature parameters, the joint probability density, the first probability density, and the initial threshold; determining a third mean value and a fourth mean value according to the preset feature parameters, the joint probability density, the second probability density, the initial threshold, and the image grayscale level; and determining the image segmentation threshold according to the first mean value, the second mean value, the third mean value, the fourth mean value, the preset feature parameters, the initial threshold, and the image grayscale level.

[0082] It is understandable that, based on preset feature parameters, joint probability density, first probability density, and an initially set threshold, the two-dimensional mean of the target contour region, including s, can be determined. 0m and s 0n , Based on preset feature parameters, joint probability density, second probability density, initial threshold, and image grayscale levels, the two-dimensional mean of the background packaging region can be determined, including s. 1m and s 1n , s 0m s is the first mean value. 0n The second mean value, s 1m The third mean value, s 1n This is the fourth average value.

[0083] In practical implementation, the sum of the absolute values ​​of the inter-class average differences of the target contour region is determined based on the above parameters. The sum of the absolute values ​​of the inter-class average differences in the background packaging area The convergence of the target contour region and the background wrapping region is calculated as D1 = p1h0(p,q) + p2h1(p,q), and the inter-class deviation between the target contour region and the background wrapping region is... The final image segmentation threshold is G(s,t)=D1-D2.

[0084] Step S22: Determine the coordinate position of the packaging of the instrument to be tested based on the instrument outline.

[0085] It should be noted that after obtaining the instrument outline and its corresponding position, each point on the instrument outline and each point on the edge of the packaging of the instrument to be tested can be used as a marker point, and the coordinate position of each marker point can be determined according to the processed test image.

[0086] Step S23: Determine the packaging status of the device to be tested based on the coordinate position.

[0087] It should be noted that after obtaining the coordinate position, the controller can determine the packaging status of the device to be tested based on the coordinate position of the marker point.

[0088] It is understandable that, in order to obtain an accurate packaging status based on coordinate position, the step of determining the packaging status of the device to be tested based on the coordinate position further includes: determining the error distance of the device to be tested packaging based on the coordinate position and a preset comparison position; determining the packaging comparison result of the device to be tested packaging based on the error distance and a preset error range; and determining the packaging status of the device to be tested packaging based on the packaging comparison result.

[0089] In practical implementation, when the medical device packaging is intact, it will expand upon heating. The packaging pressing module needs to acquire the target heating temperature of the packaging during heating. At the target heating temperature, the undamaged packaging undergoes a slight deformation. The image acquired after pressing the undamaged packaging at this point is the preset comparison image. Based on this preset comparison image, the coordinate positions of various points on the outline of the comparison device and the edge of the comparison packaging can be determined, forming the preset comparison position. When the packaging is damaged, the packaging of the device under test will not expand during heating. The coordinate positions of various points on the outline of the device and the edge of the packaging will differ from those in the intact state. The difference between the horizontal and vertical coordinates of a corner of the packaging edge and a point on the outline of the device will also differ compared to the intact state. The coordinates of the instrument outline in the processed image are compared with those of the comparison instrument outline. The coordinates of the packaging edge in the processed image are also compared with those of the comparison packaging edge. Based on the comparison results, the overall position error distance can be determined. The error distance is compared with a preset error range to determine the packaging comparison result of the instrument to be tested. When the packaging comparison result is that the error distance is within the preset error range, the packaging status is intact. When the packaging comparison result is that the error distance is not within the preset error range, the packaging status is damaged.

[0090] In this embodiment, the device outline of the instrument to be tested is determined based on the pressing image; the coordinate position of the packaging of the instrument to be tested is determined based on the device outline; and the packaging state of the packaging of the instrument to be tested is determined based on the coordinate position. The pressing image allows for rapid positioning of the device outline, and based on the device outline, the accurate coordinate position of the packaging of the instrument to be tested can be obtained, thus ensuring the accuracy of the packaging state determination process.

[0091] In addition, refer to Figure 4 This invention also proposes a medical device packaging testing device, which includes:

[0092] The acquisition module 10 is used to acquire the pressed image and surface sample information of the packaging of the instrument to be tested.

[0093] The determination module 20 is used to determine the packaging status of the device to be tested based on the pressing image.

[0094] The determining module 20 is also used to determine the disinfection status of the packaging of the instrument to be tested based on the surface sample information.

[0095] The determining module 20 is also used to determine the test result of the packaging of the instrument to be tested based on the packaging status and the disinfection status.

[0096] This embodiment acquires a pressing image and surface sample information of the packaging of the device to be tested; determines the packaging state of the packaging based on the pressing image; determines the disinfection state of the packaging based on the surface sample information; and determines the test result of the packaging based on the packaging state and the disinfection state. Through this method, pressing images and surface samples of the packaging of the device to be tested are acquired; the packaging state is determined based on the pressing image, thereby determining whether the packaging is damaged; the disinfection state is determined based on the surface sample information, thereby determining whether the packaging was properly disinfected before leaving the factory; and finally, the test result is determined based on the disinfection state and the packaging state. Based on the test result, it is determined whether the packaging meets the packaging requirements. This not only improves the efficiency of packaging testing but also ensures its accuracy.

[0097] In one embodiment, the determining module 20 is further configured to determine the device outline of the device to be tested based on the pressing image;

[0098] The coordinate position of the packaging of the instrument to be tested is determined based on the instrument outline.

[0099] The packaging status of the instrument to be tested is determined based on the coordinate position.

[0100] In one embodiment, the determining module 20 is further configured to preprocess the pressing image to obtain a processed detection image;

[0101] The image segmentation threshold is determined based on the processed and detected image;

[0102] The processed detection image is segmented according to the image segmentation threshold to obtain the device outline of the device to be detected.

[0103] In one embodiment, the determining module 20 is further configured to determine the image grayscale level, preset feature parameters, and initial set threshold based on the processed detection image;

[0104] The joint probability density of the preset feature parameters is determined based on the image grayscale levels;

[0105] The target contour region and background packaging region are determined based on the initial threshold and the processed detection image;

[0106] The first probability density of the target contour region is determined based on the initial threshold and the joint density probability.

[0107] The second probability density of the background packaging region is determined based on the image grayscale level and the joint density probability.

[0108] The image segmentation threshold is determined based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level.

[0109] In one embodiment, the determining module 20 is further configured to determine a first mean value and a second mean value based on the preset feature parameters, the joint probability density, the first probability density, and the initial set threshold.

[0110] The third mean value and the fourth mean value are determined based on the preset feature parameters, the joint probability density, the second probability density, the initial set threshold, and the image gray level.

[0111] The image segmentation threshold is determined based on the first mean value, the second mean value, the third mean value, the fourth mean value, the preset feature parameter, the initial set threshold, and the image grayscale level.

[0112] In one embodiment, the determining module 20 is further configured to determine the error distance of the packaging of the instrument to be tested based on the coordinate position and the preset comparison position;

[0113] The packaging comparison result of the device to be tested is determined based on the error distance and the preset error range;

[0114] The packaging condition of the instrument to be tested is determined based on the packaging comparison results.

[0115] In one embodiment, the determining module 20 is further configured to obtain the packaging identifier of the device packaging when the test result of the device packaging is unqualified;

[0116] A defect detection table is established based on the packaging identifier and the detection results;

[0117] Packaging filtering is performed based on the aforementioned defect detection table, and a defect statistics table is determined.

[0118] Send the defect statistics table to the administrator to alert them of packaging defects.

[0119] Since this device adopts all the technical solutions of all the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be repeated here.

[0120] Furthermore, embodiments of the present invention also propose a storage medium storing a medical device packaging testing program, wherein when the medical device packaging testing program is executed by a processor, it implements the steps of the medical device packaging testing method described above.

[0121] Since this storage medium adopts all the technical solutions of all the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be repeated here.

[0122] It should be noted that the workflow described above is merely illustrative and does not limit the scope of protection of this invention. In practical applications, those skilled in the art can select some or all of the workflow to achieve the purpose of this embodiment according to actual needs, and no restrictions are imposed here.

[0123] In addition, for technical details not described in detail in this embodiment, please refer to the medical device packaging testing method provided in any embodiment of the present invention, which will not be repeated here.

[0124] Furthermore, it should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or system that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or system. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or system that includes that element.

[0125] The sequence numbers of the above embodiments of the present invention are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.

[0126] Through the above description of the embodiments, those skilled in the art can clearly understand that the methods of the above embodiments can be implemented by means of software plus necessary general-purpose hardware platforms. Of course, they can also be implemented by hardware, but in many cases the former is a better implementation method. Based on this understanding, the technical solution of the present invention, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as read-only memory (ROM) / RAM, magnetic disk, optical disk) and includes several instructions to cause a terminal device (which may be a mobile phone, computer, server, or network device, etc.) to execute the methods described in the various embodiments of the present invention.

[0127] The above are merely preferred embodiments of the present invention and do not limit the scope of the patent. Any equivalent structural or procedural transformations made based on the description and drawings of the present invention, or direct or indirect applications in other related technical fields, are similarly included within the scope of patent protection of the present invention.

Claims

1. A medical device package inspection method, characterized by, The medical device packaging testing method includes: Acquire images of the packaging of the instrument to be tested and information on the surface samples collected; The packaging status of the device to be tested is determined based on the pressing image; The disinfection status of the packaging of the instrument to be tested is determined based on the information collected from the surface. The test results of the packaging of the instrument to be tested are determined based on the packaging status and the disinfection status. The step of determining the packaging status of the device to be tested based on the pressing image includes: The device outline of the instrument to be tested is determined based on the pressing image; The coordinate position of the packaging of the instrument to be tested is determined based on the instrument outline. The packaging status of the device to be tested is determined based on the coordinate position. The step of determining the device outline of the device to be tested based on the pressing image includes: The pressed image is preprocessed to obtain a processed detection image; The image segmentation threshold is determined based on the processed and detected image; The processed detection image is segmented according to the image segmentation threshold to obtain the device outline of the device to be detected; Wherein, determining the image segmentation threshold based on the processed and detected image includes: Based on the processed and detected image, determine the image grayscale level, preset feature parameters, and initial threshold; The joint probability density of the preset feature parameters is determined based on the image grayscale levels; The target contour region and background packaging region are determined based on the initial threshold and the processed detection image; The first probability density of the target contour region is determined based on the initial threshold and the joint probability density. A second probability density of the background packaging region is determined based on the image grayscale level and the joint probability density; The image segmentation threshold is determined based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level. The step of determining the image segmentation threshold based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level includes: The first mean value and the second mean value are determined based on the preset feature parameters, the joint probability density, the first probability density, and the initial set threshold. The third mean value and the fourth mean value are determined based on the preset feature parameters, the joint probability density, the second probability density, the initial set threshold, and the image gray level. The image segmentation threshold is determined based on the first mean value, the second mean value, the third mean value, the fourth mean value, the preset feature parameter, the initial set threshold, and the image grayscale level; The step of acquiring the pressed image of the packaging of the device to be tested includes: Obtain the standard storage temperature range of the instrument to be tested and the deformation temperature range of the packaging of the instrument to be tested, and determine the target heating temperature based on the upper limit of the standard storage temperature range and the lower limit of the deformation temperature range; The heating device is activated according to the target heating temperature to raise the temperature and cause the packaging of the instrument to be tested to deform. The pressing device is activated to press the packaging of the instrument to be tested, and an image of the pressing of the packaging of the instrument to be tested is captured.

2. The medical device package inspection method of claim 1, wherein, Determining the packaging status of the device to be tested based on the coordinate position includes: The error distance of the packaging of the instrument to be tested is determined based on the coordinate position and the preset comparison position; The packaging comparison result of the device to be tested is determined based on the error distance and the preset error range; The packaging condition of the instrument to be tested is determined based on the packaging comparison results.

3. The medical device package inspection method of claim 1, wherein, After determining the test result of the packaging of the instrument to be tested based on the packaging state and the disinfection state, the method further includes: When the test result of the packaging of the instrument to be tested is unqualified, the packaging identifier of the packaging of the instrument to be tested is obtained; A defect detection table is established based on the packaging identifier and the detection results; Packaging filtering is performed based on the aforementioned defect detection table, and a defect statistics table is determined. Send the defect statistics table to the administrator to alert them of packaging defects.

4. A medical device package inspection apparatus, characterized by, The medical device packaging testing device includes: The acquisition module is used to acquire images of the pressure points and surface samples of the packaging of the instrument to be tested. A determining module is used to determine the packaging status of the device to be tested based on the pressing image; The determining module is also used to determine the disinfection status of the packaging of the instrument to be tested based on the surface sample information; The determining module is further configured to determine the test result of the packaging of the instrument to be tested based on the packaging status and the disinfection status; The step of determining the packaging status of the device to be tested based on the pressing image includes: The device outline of the instrument to be tested is determined based on the pressing image; The coordinate position of the packaging of the instrument to be tested is determined based on the instrument outline. The packaging status of the device to be tested is determined based on the coordinate position. The step of determining the device outline of the device to be tested based on the pressing image includes: The pressed image is preprocessed to obtain a processed detection image; The image segmentation threshold is determined based on the processed and detected image; The processed detection image is segmented according to the image segmentation threshold to obtain the device outline of the device to be detected; Wherein, determining the image segmentation threshold based on the processed and detected image includes: Based on the processed and detected image, determine the image grayscale level, preset feature parameters, and initial threshold; The joint probability density of the preset feature parameters is determined based on the image grayscale levels; The target contour region and background packaging region are determined based on the initial threshold and the processed detection image; The first probability density of the target contour region is determined based on the initial threshold and the joint probability density. A second probability density of the background packaging region is determined based on the image grayscale level and the joint probability density; The image segmentation threshold is determined based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level. The step of determining the image segmentation threshold based on the preset feature parameters, the joint probability density, the first probability density, the second probability density, the initial set threshold, and the image grayscale level includes: The first mean value and the second mean value are determined based on the preset feature parameters, the joint probability density, the first probability density, and the initial set threshold. The third mean value and the fourth mean value are determined based on the preset feature parameters, the joint probability density, the second probability density, the initial set threshold, and the image gray level. The image segmentation threshold is determined based on the first mean value, the second mean value, the third mean value, the fourth mean value, the preset feature parameter, the initial set threshold, and the image grayscale level; The step of acquiring the pressed image of the packaging of the device to be tested includes: Obtain the standard storage temperature range of the instrument to be tested and the deformation temperature range of the packaging of the instrument to be tested, and determine the target heating temperature based on the upper limit of the standard storage temperature range and the lower limit of the deformation temperature range; The heating device is activated according to the target heating temperature to raise the temperature and cause the packaging of the instrument to be tested to deform. The pressing device is activated to press the packaging of the instrument to be tested, and an image of the pressing of the packaging of the instrument to be tested is captured.

5. A medical device package inspection apparatus, characterized by, The device includes: a memory, a processor, and a medical device packaging testing program stored in the memory and executable on the processor, the medical device packaging testing program being configured to implement the medical device packaging testing method as described in any one of claims 1 to 3.

6. A storage medium, characterized by The storage medium stores a medical device packaging testing program, which, when executed by a processor, implements the medical device packaging testing method as described in any one of claims 1 to 3.