CN-121996357-A - Virtual machine template library construction method and system for active medical instrument software detection

CN121996357ACN 121996357 ACN121996357 ACN 121996357ACN-121996357-A

Abstract

The application discloses a virtual machine template library construction method and a virtual machine template library construction system for active medical instrument software detection, which relate to the technical field of active medical instrument software detection and are characterized in that a targeted classification system and a four-layer basic template framework are constructed, the special dependence, the detection tool and the compliance configuration are built in, the standard requirements are highly met, 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 ensured, and the reliability of the detection result is enhanced. The automatic template generation, multidimensional retrieval interface and full life cycle dynamic management mechanism replace complex manual configuration and screening, so that the labor cost of environment deployment and template maintenance is obviously reduced, and the retrieval and management efficiency is improved. The unique identification system and the standard newly-added, iterated and archived processes avoid the disordered failure of the template, realize the standardized management and control of the template library, meet the requirement of multi-scene rapid detection and provide high-efficiency, compliance and stable environmental support for the detection of active medical instrument software.

Inventors

WANG YANYAN
LI QINGYU
ZHANG KE
HAO PENGFEI
ZHANG YANLI
YAN XIANGLIANG
Dong Hanbing

Assignees

山东省医疗器械和药品包装检验研究院

Dates

Publication Date: 20260508
Application Date: 20260205

Claims (9)

1. A virtual machine template library construction method for active medical instrument software detection is characterized by comprising the following steps: Constructing a classification system of the virtual machine template based on the detection requirement of the active medical instrument software; Constructing a basic template frame comprising an operating system layer, a proprietary dependency layer, a detection tool layer and a compliance configuration layer, and performing standard configuration; generating dedicated virtual machine templates of each category based on the classification system and the basic template frame, and distributing unique identifiers for each template; Constructing a virtual machine template library, archiving and storing the generated dedicated virtual machine templates of each class, configuring a template retrieval interface, and supporting multidimensional retrieval; Establishing a template dynamic management mechanism to realize full life cycle management of the template, wherein the full life cycle management comprises a new adding flow, an iteration flow and an archiving and eliminating flow; and calling and checking the established template, and after the verification is passed, using the template for detecting the environment deployment of the active medical instrument software.
2. The virtual machine template library construction method for active medical instrument software detection according to claim 1, wherein the virtual machine template classification system is constructed based on detection requirements of the active medical instrument software and comprises a detection type-software type-version series three-level classification structure, wherein the detection type comprises function detection, performance detection, safety detection and compatibility detection, the software type comprises equipment control software, data acquisition software, data analysis software and clinical auxiliary decision software, and the version series is divided according to a main version number of the software to be detected.
3. The method for virtual machine template library construction for active medical instrument software detection according to claim 2, wherein the constructing includes performing standard configuration of a basic template framework of an operating system layer, a proprietary dependency layer, a detection tool layer and a compliance configuration layer, and includes: An operating system layer is configured, wherein an adaptive operating system version is selected according to the main flow operation requirement of active medical instrument software, and the latest security patch is preloaded to ensure the stability and the security of an operating system; The exclusive dependency layer is configured, namely an exclusive driving program, a runtime library and a component which are required by corresponding software types are pre-installed, wherein equipment control software is correspondingly provided with a serial port communication driver and a USB driver, and data processing software is correspondingly provided with a Python runtime library and a data analysis component; configuring a detection tool layer, namely configuring a special detection tool according to a detection type, installing a Qt Test correspondingly for function detection, installing a LoadRunner correspondingly for performance detection, installing OWASP ZAP correspondingly for safety detection, and importing a special use case template for medical instrument detection; and the configuration compliance configuration layer is internally provided with forced configuration conforming to the detection standard of the active medical instrument, and comprises the steps of enabling minimum authority management and control, starting real-time log record, deploying an AES-256 data encryption module and disabling irrelevant background programs.
4. The virtual machine template library construction method for active medical instrument software detection according to claim 2 or 3, wherein the generating of each category-specific virtual machine template based on the classification system and the basic template frame, assigning unique identification to each template, comprises encoding the unique identification with a detection type encoding-software type encoding-version series encoding-adaptation standard encoding as the encoding rule of the unique identification, and associating the detection item name, the detected software model and the adaptation standard full scale metadata.
5. The method for constructing a virtual machine template library for active medical instrument software detection according to claim 4, wherein the step of establishing a template dynamic management mechanism to realize full life cycle management of the template comprises a new adding process, an iteration process and an archive elimination process, and the method comprises the steps of: When a new detection type, a new software model or new version software appears, a detection personnel submits a template creation application, and a system automatically checks compliance of application information after attaching operating system requirements, relying on a software list and compliance configuration requirement information, and generates a new template based on a basic template framework; When standard update or depending on software release security patches is detected, the system automatically triggers template update reminding, after confirmation of detection personnel, the corresponding category templates are updated in batches to be configured or patched in a compliance mode, version records are reserved after update, and update time, update content and update personnel are marked; And (3) automatically archiving the template corresponding to the old version software which is stopped to be maintained to a historical template area and storing the template in an encrypted mode, wherein the template can not be directly called after archiving, and an unlocking application is required to be submitted and audited to pass through the rear part for use.
6. The virtual machine template library construction method for active medical instrument software detection according to claim 5, wherein the calling and verification of the established template is performed, and after verification, the virtual machine template library construction method for active medical instrument software detection environment deployment comprises the following steps: the detection personnel inputs the detection requirement through the retrieval interface, the system matches the optimal template and calls out the optimal template, and a template verification program is started; The system automatically detects the integrity of the operation system of the template, depends on the availability of software and the validity of compliance configuration, and can be used for the environment deployment of the software detection of the active medical instrument after verification.
7. The virtual machine template library construction method for active medical instrument software detection according to claim 3, wherein the configuration compliance configuration layer further comprises time synchronization configuration, wherein the time synchronization configuration ensures that the system time of the template is synchronous with the standard time, and the time accuracy of the detection log is ensured.
8. The method for constructing a virtual machine template library for active medical instrument software detection according to claim 6, wherein the template dynamic management mechanism further comprises time synchronization configuration, wherein the time synchronization configuration ensures that the system time of the template is synchronous with the standard time, and ensures the time accuracy of the detection log.
9. A virtual machine template library construction method for active medical instrument software detection is characterized by comprising the following steps: the classification system construction module is used for constructing a classification system of the virtual machine template based on the detection requirement of the active medical instrument software; The basic template frame construction module is used for constructing a basic template frame comprising an operating system layer, a proprietary dependent layer, a detection tool layer and a compliance configuration layer and performing standard configuration; The exclusive template generation module is used for generating exclusive virtual machine templates of all categories based on the classification system and the basic template frame, and distributing unique identifiers for each template; the template library building module is used for building a virtual machine template library, archiving and storing the generated special virtual machine templates of each class, configuring a template retrieval interface and supporting multidimensional retrieval; The dynamic management module is used for establishing a template dynamic management mechanism to realize full life cycle management of the template, and comprises a new adding flow, an iteration flow and an archiving and eliminating flow; And the verification module is used for calling and verifying the established template, and is used for detecting the environment deployment of the active medical instrument software after the verification is passed.

Description

Virtual machine template library construction method and system for active medical instrument software detection Technical Field The application relates to the technical field of active medical instrument software detection, in particular to a virtual machine template library construction method and system for active medical instrument software detection. Background The detection of active medical instrument software (such as breathing machine control software, ultrasonic equipment data processing software and the like) needs to strictly follow the special standards of GB/T25000.51-2016, YY/T0664-2020 and the like, and has extremely high requirements on compliance, stability and suitability of detection environments. In the existing detection process, the detection environment is deployed with a multi-reliance manual configuration or a universal virtual machine (hereinafter referred to as a virtual machine) template, wherein the universal virtual machine template only provides a basic operating system and a small amount of universal software configuration, and is not subjected to customized design aiming at the detection scene of the medical instrument. The prior art has the following defects that firstly, the general virtual machine template lacks special configuration required by medical instrument detection, a detector needs to manually install a dependent drive and special detection tool of the detected software, and compliance parameters (such as authority control and log record) need to be additionally configured, so that the environment deployment is time-consuming and labor-consuming, and the labor cost is extremely high. Secondly, the different types and versions of active medical instrument software have large difference in requirements on detection environments, the universal template cannot realize accurate adaptation, parameter deviation is easy to occur in manual adjustment, and therefore the detection environments are poor in consistency, and the reliability of detection results is further affected. Thirdly, the universal template has no targeted dynamic management mechanism, and when standard updating, newly-added software version or old version elimination is detected, the updating and archiving operations of the template are complicated, and the problem of disorder or failure of the template is easy to occur. Fourth, the universal templates lack a unified identification system, detection personnel need to manually screen matched templates, retrieval efficiency is low, and rapid detection requirements of multi-version and multi-type medical instrument software are difficult to meet. Therefore, a virtual machine template library construction scheme suitable for an active medical instrument software detection scene is needed to solve the problems of poor adaptability, low deployment efficiency, management confusion and the like of the conventional universal template. Disclosure of Invention In order to solve the technical problems, the application provides the following technical scheme: In a first aspect, an embodiment of the present application provides a virtual machine template library construction method for active medical instrument software detection, including: Constructing a classification system of the virtual machine template based on the detection requirement of the active medical instrument software; Constructing a basic template frame comprising an operating system layer, a proprietary dependency layer, a detection tool layer and a compliance configuration layer, and performing standard configuration; generating dedicated virtual machine templates of each category based on the classification system and the basic template frame, and distributing unique identifiers for each template; Constructing a virtual machine template library, archiving and storing the generated dedicated virtual machine templates of each class, configuring a template retrieval interface, and supporting multidimensional retrieval; Establishing a template dynamic management mechanism to realize full life cycle management of the template, wherein the full life cycle management comprises a new adding flow, an iteration flow and an archiving and eliminating flow; and calling and checking the established template, and after the verification is passed, using the template for detecting the environment deployment of the active medical instrument software. In one possible implementation manner, the classification system of the virtual machine template is constructed based on the detection requirement of the active medical instrument software, and comprises a detection type-software type-version series three-level classification structure, wherein the detection type comprises function detection, performance detection, safety detection and compatibility detection, the software type comprises equipment control software, data acquisition software, data analysis software and clinical auxiliary decision software, and the ve