• Journal of Internet Computing and Services
• /
• v.20 no.3
• /
• pp.69-75
• /
• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• Proceedings of the Safety Management and Science Conference
• /
• 2012.11a
• /
• pp.435-443
• /
• 2012

First introduced in 1962, LED(light-emitting diodes) emitted low-intensity red light, but modern versions are now available across the ultraviolet, visible, and infrared spectrum, many with very high luminance or brightness. As a result, growing importance of potential safety harzards for human. Now when certificated of CE provide that testing through IEC/EN 62471 for any lamp. Korea standard adopted as it IEC 62471:2006, Photobiological safety of lamps and lamp systems without change, but effectiveness is incomplete. In this paper, we introduce analysis and direction that urgently come into effectiveness of KS C IEC 62471 as a national standard specifications.

• Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
• /
• v.28 no.12
• /
• pp.6-12
• /
• 2014

The safety and reliability of the power system short-circuit current, the short-circuit current depends on the failure to obtain the objective is to quickly eliminate the breaking capacity of the circuit-breaker selection of the cable, the insulation of electrical equipment and protective relay an important factor in determining the level correction and protective relay selection scheme to be meaningful. Standards used in the domestic circuit breaker is applied to the production of IEC standard, but the American National Standards (ANSI / IEEE) by NEMA specification of the fault current calculations and the application of the asymmetric coefficient Korea. Therefore, in this paper, the IEC 60909 standard IEC breaker fault current calculation method and the method for selection of system configurations reviewed and protection system for reviewing the configuration of various protective relays appropriate correction and the correction value is main protection, back-up protection the equipment so that the period of protection relay coordination to minimize accidents and accident protection to minimize interruptions proposed for cooperation.

• Journal of the Korean Solar Energy Society
• /
• v.30 no.6
• /
• pp.59-65
• /
• 2010

Analysis on turbulence intensity profile depending on wind speed is an important process to set up design condition of wind turbine in terms of fatigue load. This paper tests goodness of fit of turbulence intensity empirical equations suggested by the IEC 61400 Standards with Jejudo Gimnyeong met-tower measurement, which is erected at a seashore. Therefore sea breeze and land breeze coexist. Sea breeze case showed apparent increasing trend of turbulence intensity in a high wind speed regime due to increase of sea surface roughness. However, neither inland wind turbine standard IEC 61400-1 nor offshore wind turbine standard IEC 61400-3 fit such a trend adequately. On the other hand, the modified empirical equation of turbulence intensity of IEC 61400-3 derived from Germany FINO1 application study by considering turbulence intensity behavior in a high wind speed regime showed good agreement with the measurement. Therefore, we can reconfirm and conclude that IEC 61400-3 Ed.1 legislated in 2009 needs to be modified.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.8 no.3
• /
• pp.601-614
• /
• 2007

Lately, as importance of biometric is recognized, domestic and foreign biometric software market is soaring and the requests of high reliability and quality of biometric software are inclosed. Evaluation items and criteria must be established for the biometric software quality certification. In this paper, we development the evaluation module for biometric software test based on ISO/IEC 12119 that is the standard about package software quality requirement and test, and ISO/IEC 9126 that is the standard about evaluation of software product, and ISO/IEC 14598-6 that is the standard for construction of the evaluation module. We think that this study can be used in establishing the software quality evaluation method of bio information processing software and constructing the basis for quality improvement.

• Journal of the Korean Society of Safety
• /
• v.35 no.2
• /
• pp.111-117
• /
• 2020

When KS C IEC 60069-10-1(2015) standard is applied to estimate a hazardous area, the chart showing the relationship between a hazardous area distance and release characteristic is used as a guide to determine the extent of hazardous zones for various forms of release. Three release characteristic lines based on the three types of release as an unimpeded jet release with high velocity, a diffusive jet release with low velocity, and a release of heavy gases or vapours that spread along horizontal surfaces are given. As these characteristic lines have the low limit threshold, it is difficult to estimate the hazardous area distance when the value of release characteristic is under the low limit threshold. And KS C IEC 60079-10-1(2015) standard shows the concept for a zone of Negligible extent(NE) which can be considered as non hazardous area, but it is also difficult to apply the concept of a Negligible extent. The purpose of this paper is to suggest the guideline for the release characteristic to decide a hazardous area distance and the Negligible extent(NE) being considered as non-hazardous area when deciding a hazardous area distances by the KS C IEC 60079-10-1 standard.

• The KIPS Transactions:PartD
• /
• v.13D no.5 s.108
• /
• pp.699-708
• /
• 2006

The latest biometric field have marched fast with security technology of IT. As importance of present biometrics is realized, internal and external biometrics software market is trend that is soaring. Accordingly, high reliability of biometric software and request of high quality software are enlarged. Evaluation items and criteria must be established for biometric software quality assurance. In this paper, we development the evaluation module for biometric software test based on ISO/IEC 12119 that is the standard about software quality requirement and test, and ISO/IEC 9126 that is standard about evaluation of software product, and ISO/IEC 14598-6 that is the standard about construction of the evaluation module. Constituents of biometric software products(product descriptor, user document program and data) is subject to the quality evaluation module that we developed in this paper, we can expect improvement in the quality of software by using with a standard such as ISO/IEC 9126-3 that can be used in software development process.

• Journal of KIISE
• /
• v.42 no.9
• /
• pp.1147-1161
• /
• 2015

The ISO/IEC 11179 Metadata registry (MDR) is an international standard that was developed to register and share metadata. ISO/IEC 11179 represents an MDR as a metamodel that is an object model. However, it is difficult to develop an MDR based on ISO/IEC 11179 because the standard has no clear criteria to transform the metamodel into a database. In this paper, we suggest the design of an MDR data model that is based on object-relational transformation methodology (ORTM) for the MDR implementation. Hence, we classify the transformation methods of ORTM according to the corresponding relationships. After classification, we propose modeling rules by defining the standard use of the transformation. This paper builds the relational database tables as an implementation result of an MDR data model. Through experiments and evaluation, we verify the proposed modeling rules and evaluate the suitability of the created table structures. As the result, the proposed method shows that the table structures preserve classes and relationships of the standard metamodel well.

• Journal of the Korean Institute of Gas
• /
• v.28 no.1
• /
• pp.19-26
• /
• 2024

In workplaces handling flammable gas such as hydrogen, hazardous area is determined through KS C IEC 60079-10-1 standard. Because this standard determines the hazardous distance based on the release characteristic regardless of the type of gas, indoor/outdoor conditions, and atmospheric conditions, concerns are being raised about the effectiveness. In this study, simulations (PHAST, HyRAM) were performed to calculate the hazardous distance for hydrogen under various release characteristics and atmospheric conditions, and compared these results to IEC standard log-log graph. Also, we performed regression analysis according to each result. we found that the simulation results were 0.6 to 3.8 times less than the IEC standard, presented convenient linear regression equations. In addition, We confirmed that the results of hazardous distance varied based on wind velocity and atmospheric stability at the same release characteristic. In addition, we derived linear regression equations for release characteristics and hazardous distance that can be conveniently utilized. So, when classifying hazardous area in workplaces where they handle the hydrogen, the integrated graph and linear regression equation are helpful for confirming the hazardous area. Moreover, it is expected that the economic burden will be minimized by being able to classify reasonable hazardous area and to greatly reduce the risk of hydrogen explosion.

• The Transactions of The Korean Institute of Electrical Engineers
• /
• v.63 no.11
• /
• pp.1564-1570
• /
• 2014

An electric vehicle (EV) not only receives electric power from the electric vehicle supply equipment (EVSE), but it also exchanges the information regarding charging process with the power gird through the EVSE. However, the EV and EVSE communicate using the ISO/IEC 15118 standard while the EVSE and power grid communicate using the IEC 61850 standard. Therefore, the EVSE should support both the ISO/IEC 15118 and IEC 61850 standards, and provide a data mapping function between the two communication protocols so that the EV and power grid, which support different protocols, can communicate with each other throughout the charging process. In this paper, we propose a mapping method of the EVSE, which converts the ISO/IEC 15118 data to IEC 61850 and vice versa, based on the XML schema of each protocol. The proposed method converts the data using the XSL (eXtensible Stylesheet Language) method, which defines the data mapping between two XML schemas. Our approach is more flexible and easier to maintain against changes in charging scenarios and the standards than other existing approaches such as one-to-one data mapping methods.