Virtual machine template library construction method and system for active medical instrument software detection

Abstract

The invention discloses a virtual machine template library construction method and system for active medical instrument software detection, and relates to the technical field of active medical instrument software detection, a targeted classification system and a four-layer basic template frame are constructed, exclusive dependence, detection tools and compliance configuration are built in, the standard requirements are highly met, and the detection efficiency is improved. The adaptation precision of the template and medical instrument software of different types and versions is greatly improved, the consistency of the detection environment is guaranteed, and the reliability of the detection result is enhanced. Automatic template generation, a multi-dimensional retrieval interface and a full-life-cycle dynamic management mechanism replace tedious manual configuration and screening, the labor cost of environment deployment and template maintenance is remarkably reduced, and the retrieval and management efficiency is improved. The new, iteration and archiving process of the unique identification system and specification avoids the disorder and failure of the template, realizes the standardized management and control of the template library, meets the requirements of multi-scene rapid detection, and provides efficient, compliant and stable environment support for the software detection of the active medical instrument.

Description

Technical Field

[0001] This application relates to the field of active medical device software testing technology, specifically to a method and system for constructing a virtual machine template library for active medical device software testing. Background Technology

[0002] The testing of active medical device software (such as ventilator control software and ultrasound equipment data processing software) must strictly comply with specific standards such as GB / T 25000.51-2016 and YY / T 0664-2020, which places extremely high demands on the compliance, stability, and adaptability of the testing environment. In the current testing process, the deployment of the testing environment mostly relies on manual configuration or general virtual machine (hereinafter referred to as "virtual machine") templates. Among them, general virtual machine templates only provide a basic operating system and a small number of general software configurations, and are not customized for medical device testing scenarios.

[0003] Existing technologies suffer from the following drawbacks: First, general-purpose virtual machine templates lack the specific configurations required for medical device testing. Testing personnel must manually install the dependent drivers and dedicated testing tools for the software under test, and additionally configure compliance parameters (such as access control and logging), resulting in time-consuming and labor-intensive environment deployment with extremely high manual costs. Second, different types and versions of active medical device software have significantly different requirements for the testing environment. General-purpose templates cannot achieve precise adaptation, and manual adjustments are prone to parameter deviations, leading to poor consistency in the testing environment and consequently affecting the reliability of test results. Third, general-purpose templates lack a targeted dynamic management mechanism. When testing standards are updated, new software versions are added, or old versions are phased out, updating and archiving templates becomes cumbersome, easily leading to template confusion or invalidation. Fourth, general-purpose templates lack a unified identification system, requiring testing personnel to manually filter and match templates, resulting in low retrieval efficiency and difficulty in meeting the rapid testing needs of multiple versions and types of medical device software.

[0004] Therefore, there is an urgent need for a virtual machine template library construction solution that is adapted to the active medical device software testing scenario, in order to solve the problems of poor adaptability, low deployment efficiency and chaotic management of existing general templates. Summary of the Invention

[0005] In order to solve the above-mentioned technical problems, this application proposes the following technical solution: In a first aspect, embodiments of this application provide a method for constructing a virtual machine template library for active medical device software testing, including: A classification system for virtual machine templates is constructed based on the detection requirements of active medical device software. Build a basic template framework that includes an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and configure it according to standards. Based on the aforementioned classification system and basic template framework, generate exclusive virtual machine templates for each category and assign a unique identifier to each template; Build a virtual machine template library, archive and store the generated exclusive virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval; Establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process; The established template is called and validated. Once validated, it is used for deployment in the active medical device software testing environment.

[0006] In one possible implementation, the classification system for constructing virtual machine templates based on the testing requirements of active medical device software includes: a three-level classification structure of testing type, software type, and version series, wherein: testing type includes functional testing, performance testing, security testing, and compatibility testing; software type includes device control software, data acquisition software, data analysis software, and clinical decision support software; and version series is divided according to the major version number of the software under test.

[0007] In one possible implementation, the construction includes a basic template framework comprising an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and is configured according to standards, including: Configure the operating system layer: Select the appropriate operating system version based on the mainstream operating requirements of the active medical device software, and pre-install the latest security patches to ensure the stability and security of the operating system. Configure a dedicated dependency layer: pre-install the dedicated drivers, runtime libraries and components required for the corresponding software type. For example, for device control software, install the serial communication driver and USB driver, and for data processing software, install the Python runtime library and data parsing component. Configure the testing tool layer: Configure dedicated testing tools according to the testing type. For functional testing, install Qt Test; for performance testing, install LoadRunner; for safety testing, install OWASP ZAP; and import the medical device testing-specific test case template. Configuration compliance layer: Built-in mandatory configuration that complies with active medical device testing standards, including enabling least privilege management, enabling real-time logging, deploying an AES-256 data encryption module, and disabling irrelevant background programs.

[0008] In one possible implementation, based on the classification system and basic template framework, a virtual machine template for each category is generated, and a unique identifier is assigned to each template, including: an encoding rule with the unique identifier being the detection type code - software type code - version series code - adaptation standard code, and associated with the metadata of the detection item name, the software model under test, and the full name of the adaptation standard.

[0009] In one possible implementation, the establishment of a dynamic template management mechanism enables full lifecycle management of templates, including new template creation processes, iteration processes, and archive / deprecation processes, including: When a new testing type, new software model, or new version of software appears, the testing personnel submit a template creation application, along with information on operating system requirements, a list of dependent software, and compliance configuration requirements. The system automatically verifies the compliance of the application information and generates a new template based on the basic template framework. When the testing standards are updated or security patches are released for the software that relies on them, the system automatically triggers a template update reminder. After the testing personnel confirm the update, they can update the corresponding category of templates with compliance configurations or patches in batches. The update records are retained after the update, and the update time, update content and updater are marked. Templates for older versions of software that are no longer maintained will be automatically archived to the historical template area and stored in an encrypted manner. Once archived, they cannot be directly accessed; an unlocking application must be submitted and approved before they can be used.

[0010] In one possible implementation, the step of calling and validating the established template, and then deploying it in the active medical device software testing environment after successful validation, includes: The testing personnel input their testing requirements through the search interface, the system matches and retrieves the optimal template, and starts the template verification process. The system automatically checks the integrity of the operating system, the availability of dependent software, and the validity of compliant configurations of the template. Once the verification is passed, it can be used for deployment in the active medical device software testing environment.

[0011] In one possible implementation, the configuration compliance configuration layer further includes: time synchronization configuration to ensure that the system time of the template is synchronized with the standard time, thereby ensuring the time accuracy of the detection logs.

[0012] In one possible implementation, the template dynamic management mechanism further includes: time synchronization configuration to ensure that the system time of the template is synchronized with the standard time, thereby guaranteeing the time accuracy of the detection logs.

[0013] Secondly, embodiments of this application provide a method for constructing a virtual machine template library for active medical device software testing, comprising: The classification system construction module is used to build a classification system for virtual machine templates based on the detection requirements of active medical device software; The basic template framework building module is used to build a basic template framework that includes an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and to perform standard configuration. The dedicated template generation module is used to generate dedicated virtual machine templates for each category based on the classification system and the basic template framework, and assign a unique identifier to each template; The template library building module is used to build a virtual machine template library, archive and store the generated virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval. The dynamic management module is used to establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process; The verification module is used to call and verify the established template. Once the verification is successful, it can be used for deployment in the active medical device software testing environment.

[0014] In this embodiment, a targeted classification system and a four-layer basic template framework are constructed, incorporating dedicated dependencies, detection tools, and compliant configurations. This highly aligns with standard requirements, significantly improving the compatibility accuracy of templates with different types and versions of medical device software, ensuring consistency in the testing environment, and enhancing the reliability of test results. Automated template generation, multi-dimensional search interfaces, and a dynamic lifecycle management mechanism replace tedious manual configuration and screening, significantly reducing the labor costs of environment deployment and template maintenance, and improving search and management efficiency. A unique identifier system and standardized processes for adding, iterating, and archiving templates prevent template chaos and failure, achieving standardized management of the template library, meeting the rapid testing needs of multiple scenarios, and providing efficient, compliant, and stable environmental support for active medical device software testing. This effectively solves the pain points of existing general virtual machine templates in active medical device software testing scenarios, such as poor adaptability, low deployment efficiency, and chaotic management. Attached Figure Description

[0015] Figure 1 A flowchart illustrating a method for constructing a virtual machine template library for active medical device software testing, provided in an embodiment of this application; Figure 2 This is a schematic diagram of a virtual machine template library construction system for active medical device software testing, provided in an embodiment of this application. Detailed Implementation

[0016] The present solution will now be described in conjunction with the accompanying drawings and specific embodiments.

[0017] See Figure 1 The virtual machine template library construction method for active medical device software testing provided in this embodiment includes: S101, a classification system for virtual machine templates is constructed based on the detection requirements of active medical device software.

[0018] A classification system for virtual machine templates is established, which is constructed based on the testing requirements of active medical device software, specifically adopting a three-level classification structure of "test type - software type - version series". Test types include functional testing, performance testing, safety testing, and compatibility testing; software types include device control software, data acquisition software, data analysis software, and clinical decision support software; version series are divided according to the major version number of the software under test, including V1.X series, V2.X series, etc.

[0019] S102, construct a basic template framework including the operating system layer, dedicated dependency layer, detection tool layer and compliance configuration layer and perform standard configuration.

[0020] In this embodiment, the operating system layer, the dedicated dependency layer, the detection tool layer, and the compliance configuration layer are configured according to the following standards: Operating system layer: Based on the mainstream operating requirements of active medical device software, select the appropriate operating system version, including Windows 10 Pro 64-bit, Ubuntu 20.04 LTS, etc., and pre-install the latest security patches to ensure the stability and security of the operating system.

[0021] Dedicated dependency layer: Pre-installs the dedicated drivers, runtime libraries and components required for the corresponding software type. For example, serial communication drivers and USB drivers are installed for device control software, and Python runtime libraries and data parsing components are installed for data processing software.

[0022] Testing Tool Layer: Configure dedicated testing tools according to testing type. For functional testing, install Qt Test; for performance testing, install LoadRunner; and for security testing, install OWASP ZAP. Import the medical device testing-specific test case template.

[0023] Compliance Configuration Layer: Includes mandatory configurations that comply with active medical device testing standards, such as enabling least privilege management (only granting necessary operational permissions for testing), enabling real-time logging (logs are retained for ≥90 days, recording environment deployment process and testing operation history), deploying an AES-256 data encryption module (automatically encrypting and storing sensitive testing data), and disabling irrelevant background programs (to avoid interfering with the testing process). It also includes time synchronization configuration to ensure the template's system time is synchronized with the standard time, guaranteeing the accuracy of the testing logs.

[0024] S103. Based on the classification system and basic template framework, generate exclusive virtual machine templates for each category and assign a unique identifier to each template.

[0025] In this embodiment, the encoding rule of the unique identifier is "detection type code - software type code - version series code - adaptation standard code", and it is associated with metadata such as the name of the detection item, the model of the software under test, and the full name of the adaptation standard; for example, the code "GN-DCS-V2-YY / T0664" corresponds to the template "functional detection - equipment control software - V2 series - adaptation to YY / T 0664 standard".

[0026] S104: Build a virtual machine template library, archive and store the generated virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval.

[0027] In this embodiment, the generated virtual machine templates of each category are archived and stored according to a three-level classification system, and a template retrieval interface is configured to support multi-dimensional retrieval by detection type, software model, version series, identification code, and other dimensions.

[0028] S105, Establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process.

[0029] Specifically, in this embodiment, the new process is as follows: when a new type of testing, a new software model, or a new version of software appears, the testing personnel submit a template creation application, along with information such as operating system requirements, a list of dependent software, and compliance configuration requirements. After the system automatically verifies the compliance of the application information, it generates a new template based on the basic template framework. After being reviewed and approved by at least one senior testing engineer, the template is entered into the template library.

[0030] The iterative process is as follows: When the detection standard is updated or the dependent software releases a security patch, the system automatically triggers a template update reminder. After the detection personnel confirm, the corresponding category templates are updated in batches with compliance configurations or patches. After the update, version records are retained, and the update time, update content and updater are marked. The archiving and elimination process is as follows: For templates corresponding to old versions of software that are no longer maintained, they are automatically archived to the historical template area and stored in an encrypted manner (retained for at least 2 years for traceability). After archiving, they cannot be directly accessed. An unlocking application must be submitted and approved before they can be used.

[0031] In this embodiment, the template dynamic management mechanism also includes a template usage statistics function, which records the number of times each template is called, the type of project being tested, and the duration of use, providing data support for template optimization.

[0032] S106 calls and verifies the established template. Once verified, it is used for deployment in the active medical device software testing environment.

[0033] Testing personnel input their testing requirements through the search interface. The system matches and retrieves the optimal template, initiates the template verification program, and automatically checks the template's operating system integrity, dependent software availability, and compliance configuration validity. Once the verification is passed, the template can be deployed in the active medical device software testing environment.

[0034] This embodiment, based on the construction method provided in this embodiment, constructs a virtual machine template for functional testing of the ultrasonic equipment control software V2.X series, and applies it to an actual testing scenario. The specific steps are as follows: 1. Classification system positioning: Determine the target template as "Functional testing - Ultrasonic equipment control software - V2.X series" in the three-level classification system.

[0035] 2. Basic template framework configuration: Operating system level: Select Windows 10 Pro 64-bit operating system, install security patch KB5030219, and format the system disk to NTFS format.

[0036] Dedicated dependency layer: Install the dedicated image acquisition driver (version V3.2.1), serial communication driver (version V1.8), and .NET Framework 4.8 runtime library for ultrasound equipment. Test driver compatibility to ensure normal communication between the ultrasound equipment and the virtual machine.

[0037] Testing tool layer: Install Qt Test 5.15.2, import the dedicated script template for ultrasound equipment control software function testing. This template contains test cases for core functions such as image acquisition, parameter adjustment, and data storage. Set the default running permissions of the tool to "testing only".

[0038] Compliance Configuration Layer: Disable automatic administrator login via Group Policy, create a "Detection Operator" account (only granting permissions to run detection-related programs); enable Windows Event Log and custom detection log, set the log storage path to D:\MedicalTest\Log, the recording frequency to real-time, and the retention period to 180 days; install the AES-256 encryption module, and set the detection data storage directory D:\MedicalTest\Data to be automatically encrypted; disable Windows Update, Edge browser automatic startup, and other irrelevant programs; enable time synchronization to ensure that the system time is consistent with the standard time.

[0039] 3. Dedicated Template Generation: Assign a unique identifier code "GN-US-V2-YY / T0664" to the template configured above, and associate it with metadata (Testing item: Functional testing of ultrasound equipment control software; Software model: US-2023A; Adaptation standard: YY / T 0664-2020 "Medical Device Software Life Cycle Process").

[0040] 4. Template Library Archiving: Enter the template into the virtual machine template library and archive it in the "Functional Testing - Equipment Control Software - V2.X Series" directory. Synchronize it to the retrieval system and support retrieval by dimensions such as "Ultrasonic Equipment", "V2.X", and "YY / T0664".

[0041] 5. Template Retrieval and Verification: A testing organization needs to perform functional testing on the V2.1 version of the control software for a US-2023A ultrasonic device. The testing personnel input "ultrasonic device V2.1-functional testing-YY / T0664" through the search interface, and the system quickly matches the template identified as "GN-US-V2-YY / T0664". The verification program is started, which automatically checks the integrity of the operating system patches, driver availability, and compliance configuration validity of the template. After the verification is passed, the testing environment is quickly deployed based on the template, and the testing process is started directly after the deployment is completed.

[0042] 6. Template Iteration: When a new version of the YY / T 0664 standard is released, the system will automatically trigger a template update reminder. After the testing personnel confirm, the compliance configuration layer parameters of the template will be updated in batches. After the update is completed, the version information will be recorded (update time: 202X year X month X day; update content: adapt to the compliance configuration of the new YY 0664-202X standard; updater: XXX).

[0043] Corresponding to the virtual machine template library construction method for active medical device software testing provided in the above embodiments, this application also provides an embodiment of a virtual machine template library construction system for active medical device software testing.

[0044] See Figure 2 A virtual machine template library construction system 20 for active medical device software testing includes: The classification system construction module 201 is used to construct a classification system for virtual machine templates based on the detection requirements of active medical device software.

[0045] The basic template framework building module 202 is used to build a basic template framework that includes an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and to perform standard configuration.

[0046] The dedicated template generation module 203 is used to generate dedicated virtual machine templates for each category based on the classification system and the basic template framework, and assign a unique identifier to each template.

[0047] The template library building module 204 is used to build a virtual machine template library, archive and store the generated virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval.

[0048] The dynamic management module 205 is used to establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process.

[0049] The verification module 206 is used to call and verify the established template. After the verification is successful, it is used for deployment in the active medical device software testing environment.

[0050] In this application embodiment, "at least one" refers to one or more, and "more than one" refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent the existence of A alone, the simultaneous existence of A and B, or the existence of B alone. A and B can be singular or plural. The character " / " generally indicates that the preceding and following related objects have an "or" relationship. "At least one of the following" and similar expressions refer to any combination of these items, including any combination of single or plural items. For example, at least one of a, b, and c can represent: a, b, c, ab, ac, bc, or abc, where a, b, and c can be single or multiple.

[0051] The above description is merely a specific embodiment of this application. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the protection scope of this application. The protection scope of this application should be determined by the protection scope of the claims.

Claims

1. A method for constructing a virtual machine template library for active medical device software testing, characterized in that, include: A classification system for virtual machine templates is constructed based on the detection requirements of active medical device software. Build a basic template framework that includes an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and configure it according to standards. Based on the aforementioned classification system and basic template framework, generate exclusive virtual machine templates for each category and assign a unique identifier to each template; Build a virtual machine template library, archive and store the generated exclusive virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval; Establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process; The established template is called and validated. Once validated, it is used for deployment in the active medical device software testing environment.

2. The method for constructing a virtual machine template library for active medical device software testing according to claim 1, characterized in that, The classification system for constructing virtual machine templates based on the testing requirements of active medical device software includes: a three-level classification structure of testing type, software type, and version series. Among them, testing type includes functional testing, performance testing, security testing, and compatibility testing; software type includes device control software, data acquisition software, data analysis software, and clinical decision support software; and version series is divided according to the major version number of the software under test.

3. The method for constructing a virtual machine template library for active medical device software testing according to claim 2, characterized in that, The construction includes a basic template framework comprising an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and performs standard configuration, including: Configure the operating system layer: Select the appropriate operating system version based on the mainstream operating requirements of the active medical device software, and pre-install the latest security patches to ensure the stability and security of the operating system. Configure a dedicated dependency layer: pre-install the dedicated drivers, runtime libraries and components required for the corresponding software type. For example, for device control software, install the serial communication driver and USB driver, and for data processing software, install the Python runtime library and data parsing component. Configure the testing tool layer: Configure dedicated testing tools according to the testing type. For functional testing, install Qt Test; for performance testing, install LoadRunner; for safety testing, install OWASP ZAP; and import the medical device testing-specific test case template. Configuration compliance layer: Built-in mandatory configuration that complies with active medical device testing standards, including enabling least privilege management, enabling real-time logging, deploying an AES-256 data encryption module, and disabling irrelevant background programs.

4. The method for constructing a virtual machine template library for active medical device software testing according to claim 2 or 3, characterized in that, Based on the classification system and basic template framework, exclusive virtual machine templates for each category are generated, and a unique identifier is assigned to each template, including: an encoding rule with the unique identifier being detection type code - software type code - version series code - adaptation standard code, and associated with the metadata of the detection item name, the software model under test, and the full name of the adaptation standard.

5. The method for constructing a virtual machine template library for active medical device software testing according to claim 4, characterized in that, The establishment of a dynamic template management mechanism enables full lifecycle management of templates, including new template processes, iteration processes, and archived / deprecated processes. When a new testing type, new software model, or new version of software appears, the testing personnel submit a template creation application, along with information on operating system requirements, a list of dependent software, and compliance configuration requirements. The system automatically verifies the compliance of the application information and generates a new template based on the basic template framework. When the testing standards are updated or security patches are released for the software that relies on them, the system automatically triggers a template update reminder. After the testing personnel confirm the update, they can update the corresponding category of templates with compliance configurations or patches in batches. The update records are retained after the update, and the update time, update content and updater are marked. Templates for older versions of software that are no longer maintained will be automatically archived to the historical template area and stored in an encrypted manner. Once archived, they cannot be directly accessed; an unlocking application must be submitted and approved before they can be used.

6. The method for constructing a virtual machine template library for active medical device software testing according to claim 5, characterized in that, The process of calling and validating the established template, and then deploying it in the active medical device software testing environment after successful validation, includes: The testing personnel input their testing requirements through the search interface, the system matches and retrieves the optimal template, and starts the template verification process. The system automatically checks the integrity of the operating system, the availability of dependent software, and the validity of compliant configurations of the template. Once the verification is passed, it can be used for deployment in the active medical device software testing environment.

7. The method for constructing a virtual machine template library for active medical device software testing according to claim 3, characterized in that, The configuration compliance layer also includes: time synchronization configuration, which ensures that the system time of the template is synchronized with the standard time, and guarantees the time accuracy of the detection logs.

8. The method for constructing a virtual machine template library for active medical device software testing according to claim 6, characterized in that, The template dynamic management mechanism also includes: time synchronization configuration to ensure that the system time of the template is synchronized with the standard time, thus ensuring the time accuracy of the detection log.

9. A method for constructing a virtual machine template library for active medical device software testing, characterized in that, include: The classification system construction module is used to build a classification system for virtual machine templates based on the detection requirements of active medical device software; The basic template framework building module is used to build a basic template framework that includes an operating system layer, a dedicated dependency layer, a detection tool layer, and a compliance configuration layer, and to perform standard configuration. The dedicated template generation module is used to generate dedicated virtual machine templates for each category based on the classification system and the basic template framework, and assign a unique identifier to each template; The template library building module is used to build a virtual machine template library, archive and store the generated virtual machine templates of various categories, and configure a template retrieval interface to support multi-dimensional retrieval. The dynamic management module is used to establish a dynamic template management mechanism to achieve full lifecycle management of templates, including new process, iterative process, and archived and decommissioned process; The verification module is used to call and verify the established template. Once the verification is successful, it can be used for deployment in the active medical device software testing environment.

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