Earticle

본 논문에서는 의료기기 인증 표준인 IEC60601-1(3판 이후)에서 요구하는 의료기기 소프트웨어 인증 표준인 IEC62304 인증을 위한 문서 작성 가이드라인을 제안한다. 제안한 가이드라인은 국내 의료기기 업체들이 인증 문서 작 성 시 템플릿으로 사용 가능하도록 IEC62304를 9개의 세부 가이드라인으로 분류한다. 각 세부 가이드라인에 포함되 는 내용은 가능한 많은 표와 최소한의 표현으로 작성 가능하게 만들어 의료기기 업체의 부담을 줄일 수 있게 한다. 제안하는 가이드라인을 이용하여 8개의 의료기기 소프트웨어에 대한 가이드라인을 만들었으며, 의료기기 업체에 제공하여 그 효용성을 검증한다.

This paper proposes guidelines for making certification document of IEC62304, which has become the software validation standard required by IEC60601-1(version 3 or after), a medical device certification standard. The proposed guidelines are categorized with nine sub guidelines for domestic medical device makers to use the guides as templates of certification documents. The contents in the guidelines are included in many tables and designed to use brief expressions for helping the makers lessen documentation burden. The guidelines for eight medical software are made using the proposed guidelines and delivered to medical device makers for validating the effectiveness.

생체모방로봇은 조류나 곤충과 같은 생체의 특성을 모방하여 미래 전장에서 은밀한 감시와 정찰 작업에 큰 역할을 할 것으로 기대된다. 이 로봇들의 효과적인 활용을 위해서는 새의 날갯짓이나 바퀴벌레의 움직임 등을 모방하는 기술이 중요하지만, 이를 지원하는 하드웨어 확보와 소프트웨어 개발 및 검증 과정의 복잡성으로 인해 어려움이 따른다. 본 논문에서는 모델링 및 시뮬레이션(M&S) 기술을 적용한 다중 HILS 기반 생체모방로봇 소프트웨어 검증 테스트베드를 설계하고 구현한 결과를 소개한다. 테스트베드를 사용함으로써 개발자들은 하드웨어 부재 문제를 극복하고, 미래 전장 시나리오를 시뮬레이션하며 소프트웨어 개발과 테스트를 수행할 수 있다. 그러나, 다중 HILS 기반 테스트베드는 테스트 대상 로봇 수의 증가에 따른 장치 간 연동 지연 문제를 경험할 수 있으며, 이는 시뮬레이션 결과의 신뢰도에 크게 영향을 미칠 수 있다. 이를 해결하기 위해, 우리는 우선순위 기반 미들웨어인 data distribution service prority (DDSP)를 추가로 제안한다. DDSP는 기존 DDS 대비 1.95 ms의 평균 지연 감소 효과를 보이며, 테스트베드에서 요구되는 데이터 전송 품질을 보장할 수 있음을 입증하였다.

Biomimetic robots, which emulate characteristics of biological entities such as birds or insects, have the potential to offer a tactical advantage in surveillance and reconnaissance in future battlefields. To effectively utilize these robots, it is essential to develop technologies that emulate the wing flapping of birds or the movements of cockroaches. However, this effort is complicated by the challenges associated with securing the necessary hardware and the complexities involved in software development and validation processes. In this paper, we presents the design and implementation of a multi-HILS based biomimic robot software validation testbed using modeling and simulation (M&S). By employing this testbed, developers can overcome the absence of hardware, simulate future battlefield scenarios, and conduct software development and testing. However, the multi-HILS based testbed may experience inter-device communication delays as the number of test robots increases, significantly affecting the reliability of simulation results. To address this issue, we propose the data distribution service priority (DDSP), a priority-based middleware. DDSP demonstrates an average delay reduction of 1.95 ms compared to the existing DDS, ensuring the required data transmission quality for the testbed.

Software verification and validation (SVV) are major ingredients of current software engineering projects. Among the available methods to solve this problem, formal methods (although very costly at the computational level) are arguably the most powerful ones. One of the most promising approaches in this field is that based on Petri nets. This paper discusses some issues regarding the application of Petri nets to SVV from a hybrid mathematical/computational point of view. The paper also describes a Mathematica package developed by the author for a class of Petri nets, which is applied to address the SVV problem in the context of graphical semantic web services based on virtual agents evolving in digital 3D worlds.

Requirements need to be validated at the early phase of the software development to avoid errors such as inconsistency, incompleteness and incorrectness. Drawn from this argument, a requirements validation process needs to consider Consistency, Completeness and Correctness (“3 Cs”) for the production of a quality software specifications. This paper provides a review of requirements validation and consistency management based on the existing literature in order to identify the gaps in the existing knowledge on the process of software requirements specifications. This paper begins with a review of the definitions of the 3Cs,upon which the understanding of the 3Cs is derived. Next comprehensive review of related works on the identified consistency management techniques: traceability and analysis approaches are then presented. This is supported with a heat map representations of the related research on the types of contributions, techniques, specifications and semantics used in consistency management. Since semi-formal specifications were found as the most common representation of the requirements, the types of models used as semi-formal specifications to represent the requirements were also discussed. Overall, this paper identifies the various gaps existing within the process of validating and managing the consistency of requirements to avoid re-inventing the wheels in the diverse and comprehensive knowledge of requirements engineering.

Many mobile applications have evolved from simple HTML pages to complex service-oriented applications hat have high maintenance cost. This high maintenance cost is due to the heterogeneity of mobile pplications, to the fast mobile evolution and to the fast-moving market which imposes short de-velopment ycles and frequent modifications. In order to control the mainten-ance cost, quantitative metrics for redicting mobile applications’ maintaina-bility must be used. This study introduces class diagram design metrics based n Conallen’s Mobile Application Extension for UML. The study will use data from an industrial mobile pplication to show the correlation between the class diagram metrics and maintenance effort measured by the number of lines of code changed.

This paper describes the case of Independent Software Verification and Validation(V&V). As an example, verification and validation of the graphic recorder is introduced. Graphic recorder as a verification and validation paradigm describe the qualification approaching techniques and methods. Graphic recorder is a measurement data recording device with 5.5 inch TFT liquid crystal display instead of a paper. It mainly describes V&V criteria, testing approach, software verification methodology, techniques and procedures. However, hardware based equipment qualification (i.e. environment qualification, seismic qualification, and EMI/RFI qualification) has been excluded. The V&V methods for each phase of the software life cycle and V&V input-output tasks, with a focus on the processes are described. From the initial phase to the final phase of development, development and testing/verification were performed according to the software life cycle based on information engineering methodology. The suggested validation and verification paradigm is satisfied with SRP7/BTP-14 criteria, which is the digital software licensing standard for safety-critical system (for example, aerospace, railways, automobile and nuclear industry etc). The paper addresses the pass/fail criteria for each phase of the software life cycle referenced by hierarchical international standard framework.

This paper introduces the software life-cycle V&V (verification and validation) tasks for the KNICS (Korea nuclear instrumentation and control system) project. The objectives of the V&V tasks are mainly to develop a programmable logic controller (PLC) for safety critical instrumentation and control (I&C) systems, and then to apply the PLC to developing the prototype of an engineered safety features-component control system (ESF-CCS) in nuclear power plants. As preparative works for the software V&V, various kinds of software plans and V&V task procedures have been developed according to the software life-cycle management. A number of software V&V tools have been adopted or developed to efficiently support the V&V tasks. The V&V techniques employed in this work include a checklist-based review and inspection, a requirement traceability analysis, formal verification, and life-cycle based software testing.

In this paper, we present design features, implementation, and validation of a satellite simulator subsystem for the Korea Multi-Purpose Satellite-2 (KOMPSAT-2). The satellite simulator subsystem is implemented on a personal computer to minimize costs and trouble on embedding onboard flight software into the simulator. An object-oriented design methodology is employed to maximize software reusability. Also, instead of a high-cost commercial database, XML is used for the manipulation of spacecraft characteristics data, telecommand, telemetry, and simulation data. The KOMPSAT-2 satellite simulator subsystem is validated by various simulations for autonomous onboard launch and early orbit phase operations, anomaly operation, and science fine mode operation. It is also officially verified by successfully passing various tests such as the satellite simulator subsystem test, mission control element system integration test, interface test, site installation test, and acceptance test.

The deep space orbit determination software (DSODS) is a part of a flight dynamic subsystem (FDS) for the Korean Pathfinder Lunar Orbiter (KPLO), a lunar exploration mission expected to launch after 2018. The DSODS consists of several sub modules, of which the orbit determination (OD) module employs a weighted least squares algorithm for estimating the parameters related to the motion and the tracking system of the spacecraft, and subroutines for performance improvement and detailed analysis of the orbit solution. In this research, DSODS is demonstrated and validated at lunar orbit at an altitude of 100 km using actual Lunar Prospector tracking data. A set of a priori states are generated, and the robustness of DSODS to the a priori error is confirmed by the NASA planetary data system (PDS) orbit solutions. Furthermore, the accuracy of the orbit solutions is determined by solution comparison and overlap analysis as about tens of meters. Through these analyses, the ability of the DSODS to provide proper orbit solutions for the KPLO are proved.

BACKGROUND: Global longitudinal strain (GLS) is an accurate and reproducible parameter of left ventricular (LV) systolic function which has shown meaningful prognostic value. Fast, user-friendly, and accurate tools are required for its widespread implementation. We aim to compare a novel web-based tool with two established algorithms for strain analysis and test its reproducibility. METHODS: Thirty echocardiographic datasets with focused LV acquisitions were analyzed using three different semi-automated endocardial GLS algorithms by two readers. Analyses were repeated by one reader for the purpose of intra-observer variability. CAAS Qardia (Pie Medical Imaging) was compared with 2DCPA and AutoLV (TomTec). RESULTS: Mean GLS values were ?15.0 ± 3.5% from Qardia, ?15.3 ± 4.0% from 2DCPA, and ?15.2 ± 3.8% from AutoLV. Mean GLS between Qardia and 2DCPA were not statistically different (p = 0.359), with a bias of ?0.3%, limits of agreement (LOA) of 3.7%, and an intra-class correlation coefficient (ICC) of 0.88. Mean GLS between Qardia and AutoLV were not statistically different (p = 0.637), with a bias of ?0.2%, LOA of 3.4%, and an ICC of 0.89. The coefficient of variation (CV) for intra-observer variability was 4.4% for Qardia, 8.4% 2DCPA, and 7.7% AutoLV. The CV for inter-observer variability was 4.5%, 8.1%, and 8.0%, respectively. CONCLUSIONS: In echocardiographic datasets of good image quality analyzed at an independent core laboratory using a standardized annotation method, a novel web-based tool for GLS analysis showed consistent results when compared with two algorithms of an established platform. Moreover, inter- and intra-observer reproducibility results were excellent.

A continuous observation is required to check as to whether the patient uses the incentive spirometer (IS) properly, and it is difficult to quantify the extent of its use. This study aimed to develop a software to recognize the IS and to check as to whether it is possible to evaluate if the patient uses the IS properly through this software. A flow-oriented IS consisted of the three colored floating balls with inspiratory flows of 700 cc/s, 1200 cc/s, and 1900 cc/s was used. The software was consisted of the IS and its components were recognized in real time from the video recorded by the webcam. It was prepared to recognize yellow, red, and blue, which were the ball colors of the spirometer, and green, which represented the start and end lines of the ball. When the balls and green markers were recognized, the height of the IS was measured. Furthermore, the speed of inhalation was calculated as the ratio of the moving distance of the ball. Lastly, this speed was recorded every 0.02 s. The 500, 1000, and 1500 cc syringes were used to simulate inhalation. After pulling the syringes, the movements of the balls were identified, and the volume of inhaled air was calculated. The calculated volume was statistically compared to the actual volume. When the movement of the ball recognition line in the video was compared with the last moving ball, the software exactly tracked each of the three balls of the IS, and identified as to whether the IS was used and the extent of inhalation. However, it did not exactly reflect the actual inhalation volume. We developed a vision-based monitoring software to measure whether the patients used the IS well and experimentally verified it. The software can be used as a contactless modality for preventing respiratory complications after surgery.

통신해양기상위성의 정상임무 수행시 자세제어계에 대한 중요한 지상국 소프트웨어에는 궤도위치 유지와 휠오프로딩이 있는데, 본 논문에서는 외팔보 태양전지판 형상으로 인해 E3000 heritage로부터 설계 변경을 수행하여 해석을 수행한 휠오프로딩 임무에 대한 지상국 소프트웨어 검증시험을 정리하여 기술하였다. 휠오프로딩 지상국 소프트웨어는 크게 2가지로 구분되는데, 하나는 휠오프로딩을 위한 추력기 조합 변경 시기에서의 변수 변경이고 다른 하나는 위성으로 전달해야 하는 모멘텀기준값 변경이다.

There are two main software in COMS ground station at the normal mode operation - stationkeeping and wheel off-loading. In this paper, ground software validation test for wheel off-loading is summarized and described. The wheel off-loading was performed the design change from E3000 heritage and analyzed. The wheel off-loading of ground software has two part; one is wheel off-loading management for parameters change at the thruster set switching time and the other is wheel off-loading set-point being sent to satellite for the reference momentum.

본 연구는 의료기기 산업에 적용되는 소프트웨어 밸리데이션(validation) 개념을 H사의 사례연구를 통해 살펴본다. 이를 통해 실무에서 이슈가 되고 있는 소프트웨어 밸리데이션 개념을 의료기기 제조업에 널리 적용할 수 있는가에 연구의 목적을 두고 있다. 선도적인 사례 기업인 H사의 소프트웨어 밸리데이션 사례는 FDA 심사시 소프트웨어 밸리데이션 개념, 절차, 유용성검사, 밸리데이션 플랜과 보고서 사례로 구성된다. 먼저 소프트웨어 밸리데이션 절차는 테스트 선택, 의견보고서와 유용성 테스트의 검사, 평가․요약․통계자료분석, 응용과 적용에 대한 개념적인 틀이 설정되고 이러한 문서화된 개념적 틀에 대한 승인과정이 수행된다. 보고서 사례로 소프트웨어 밸리데이션은 의료기기에서 위험을 야기하는 소프트웨어를 제거할 목적으로 의료기기 펌웨어 디자인 초기단계에서 계획된다. 또한 사례기업의 밸리데이션 부분적 적용사례로는 아날로그 제품설계 및 개방을 통한 밸리데이션, 경영검토보고서의 밸리데이션, 개인별 교육․훈련 이력카드의 밸리데이션 적용 등을 그 사례로 들 수 있다. 이를 통해 소프트웨어 밸리데이션을 뒷받침하는 디자인과 프로세스 밸리데이션의 내용적․절차적 타당성의 문제점을 제시하고 그 해결방안을 제시하였다. 본 연구는 사례기업의 소프트웨어 밸리데이션 적용사례를 살펴봄으로서 국내 의료기기 산업의 제조 및 품질관리기준 운영 내실화 정착에 기여할 수 있을 것으로 기대한다.

The purpose of this paper is to study software validation concepts through the practices of H’s company that can be applied to the medical device industry. Software validation practices of H’s case firm consists of concepts, procedures, and check for the availability, plans and reports. H’s software validation case consists of the procedure, usability test, software verification and validation plan, validation reports. Report cases to software that poses risks in medical devices for the purpose of removing the software validation plan is at an early stage medical device firmware design. Also, through software validation process to support the design and validation of the contents of the review and the procedural validity, the problems presented in accordance with the H’s company case. This study is expected to be able to contribute to the settlement of the manufacturing and quality management of medical device software validation through this case study.

연구 목적: 이 연구는 유아교사 인공지능 기반 소프트웨어 교육 역량 척도를 개발하는데 있다. 연구 방법: 척도 구성, 타당화 검증 등을 실시하였다. 문헌분석을 통하여 척도의 개념과 구성요소를 도출하였다. 이를 바탕으로 척도의 초안을 구성하였다. 척도 초안은 3차례에 걸친 전문가 적절성 조사를 통해 타당도 검사를 하고 2차안을 제작하였다. 이후 10명의 유아교사를 대상으로 예비조사를 실시하여 척도를 수정하고 다시 100명의 유아교사에게 문항양호도를 검사하였다. 그리고 500명의 교사를 대상으로 척도의 타당도, 신뢰도를 검증하였다. 연구 내용: 유아교사 인공지능 기반 소프트웨어 교육 역량 척도를 개발하기 위하여 유아교사 인공지능 기반 소프트웨어 교육 역량 척도의 개념을 탐색하고 관련 척도를 마련하여 타당화 과정을 거쳤다. 결론 및 제언: 유아교사 인공지능 기반 소프트웨어 교육 역량 척도는 ‘수업준비 역량’(8문항), ‘교육과정 설계 역량’(12문항), ‘인공지능 방법으로 수업운영 역량’(10문항), ‘수업평가 역량’(8문항) 등으로 구성되었다. 본 척도는 유아교사 인공지능 기반 소프트웨어 역량을 신뢰롭고 타당하게 측정할 수 있는 척도라고 볼 수 있다. 향후 이와 유아교사의 인공지능 영역, 그리고 소프트웨어 교육 영역 연구에서 유용한 도구로 활용될 것으로 예상한다.

The purpose of this study is to develop an artificial intelligence-based software education competency scale for early childhood teachers. In order to realize the purpose of the study, scale construction and validation were conducted. The concept and components of the scale were derived through literature analysis. Based on this, a draft of the scale was constructed. The draft scale was tested for validity through three expert adequacy surveys, and a second draft was produced. Afterwards, a preliminary survey was conducted on 10 early childhood teachers, the scale was modified, and 100 early childhood teachers were tested again for item quality. And the validity and reliability of the scale were verified with 500 teachers. Research Results The AI-based software education competency scale for early childhood teachers is ‘class preparation competency’ (8 questions), ‘curriculum design competency’ (12 questions), ‘class management competency with artificial intelligence method’ (10 questions), and ‘class evaluation competence’ (8 items). This scale can be seen as a scale that can reliably and reasonably measure the AI-based software competency of early childhood teachers. In the future, it is expected to be used as a useful tool in the field of artificial intelligence of early childhood teachers and the field of software education.

The reactor protection system is the most important function for the safe operation of nuclear powerplants (NPPs) in that such system protects a nuclear reactor tore whose damage can cause an enormous disaster to the nuclear facility and the public. A digital reactor protection system (DRPS) is being developed in KAERI for use in the newly-constructed NPPs and also for replacing the existing analog-type reactor Protection systems. In this paper, an software verification and validation (V&V) activities for DRPS, which are independent of the DRPS development processes, are described according to the software development life cycle. The main activities of DRPS V&V processes are the software planning documentations, the verification of software requirements specification (SRS) and software design specification (SDS), the verification of codes, the tests of the integrated software and system. Moreover, the software safety analysis and the software configuration management are involved in the DRPS V&V processes. All of the V&V activities are described, in detail, in this paper.

최근 조선 산업의 기술이 발전함에 따라 선박의 크기 및 성능이 향상되었다. 이에 따라 한 번의 선박 간 충돌로 인한 좌초 등의 사고가 대형 해난사고를 초래할 수 있게 되었다. 이러한 심각성을 고려하여 국제 사회에서는 해사안전 향상을 위해 지속적으로 전자해도 기준을 업데이트하고 있다. 국제수로기구(IHO)에서 관리하는 기존의 전자해도 관련 표준은 S-57로, S-57 안에는 기존 이진(Binary) 형태의 전자해도 데이터를 제작하기 위한 기준이 담겨있다. 그러나 S-57은 2000년 12월 3.1 버전이 발표된 이후 업데이트가 중단되어 지속적으로 성장하고 있는 해양공간정보의 기술 경향을 반영하지 못하고 있다. IHO에서는 이러한 흐름에 대처하기 위해 차세대 전자해도 제작기준 표준인 S-100을 제정하였으며, 기존 S-57과 다른 데이터의 교환 형식을 사용하였다. 기존 전자해도의 경우에는 이진 형태로 구성되었으나 차세대 전자해도 표준을 기반으로 한 S-10X 전자해도 데이터의 경우에는 피처 카탈로그(Feature Catalogue), 포트리얼 카탈로그(Portrayal Catalogue), GML로 구성되어 있다. 이러한 점을 고려할 때 전자해도의 유효성 검증 표준인 S-58의 업데이트 또는 새로운 유효성 검증 표준의 제정이 필요하다. 본 연구에서는 이에 변화된 데이터의 유효성 검증 시험을 위해 자체 소프트웨어를 개발하였고 테스트 결과에 따른 개선점을 도출하였다.

With recent technological advances in the shipbuilding industry, vessels have been improved in size and performance. As a result, an accident such as grounding, caused by a single ship-to-ship collision, could lead to a large-scale maritime disaster. Considering the seriousness of the situation, the international community has been consistently updating the standards for Electronic Navigational Chart(ENC) to improve the maritime safety. S-57, the existing ENC standard governed by the International Hydrographic Organization(IHO), includes standards for generating conventional binary-type ENC data sets. The S-57 standard, however, has not been updated since the release of Version 3.1 in December 2000. Since then, the standard has failed to reflect technological development regarding maritime spacial information, which has been consistently improving. In an effort to address this concern, the IHO designated S-100, i.e., the next-generation ENC production standard. S-100 differs from S-57 in data exchange type. Contrary to the conventional ENC standards, which use binary-type data, S-10X, based on the next-generation ENC standards, uses ENC data composed of Feature Catalogue, Portrayal Catalogue, and GML. Considering this fact, it is necessary to update S-58, the ENC validation check standard, or designate a new standard for ENC validation checks. This study is developed own software to implement validation checks for new types of data, and identified improvement points based on the test results.