• Title/Summary/Keyword: Particular requirements

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The Tendency of Medical Electrical Equipment - IEC 60601-2-54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy (촬영 및 투시용 X선 장치의 기본안전과 필수 성능에 관한 개별 기준규격의 동향)

  • Roh, Young Hoon;Kim, Jung Min
    • Journal of radiological science and technology
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    • v.38 no.4
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    • pp.331-336
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    • 2015
  • Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipments.

The Requirements on statistical techniques in QS-9000

  • Yamada, Shu
    • International Journal of Quality Innovation
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    • v.1 no.1
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    • pp.24-31
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    • 2000
  • QS-9000 was established by Chrysler, Ford, General Motors and some Truck Manufactures to solve problems of efforts to prepare original standards for each company. When we compare the requirements in QS-9000 with those in ISO 9000, we may observe that those of QS-9000 are more specific, since the user of the standard is limited to the automobile industry. In particular, the requirements on statistical techniques are described in more detail. In this paper, we present the requirements on statistical techniques in QS-9000. Specifically, we review the contents of QS-9000 and explore the philosophy and the minimum requirement on statistical techniques behind the description.

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Design Requirements in Software and Engineering Systems

  • Eleiche, A.M.;Ahmad, I.;Elish, M.O.
    • Industrial Engineering and Management Systems
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    • v.11 no.1
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    • pp.70-81
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    • 2012
  • The subject of "Design Requirements" (DR) is central to the design of software and engineering systems. The main reason for this is that quality aspects are usually closely tied to requirements, among other things. In this review paper, we consider how the subject of requirements is being managed in these two seemingly different design disciplines. Two important aspects are covered, namely: (a) requirements development, describing various activities leading to requirements documentation, and (b) requirements change management, describing various activities needed for the proper treatment of the inevitable changes in requirements. Similarities and differences on how these two aspects are handled in software and engineering systems are highlighted. It is concluded from this literature survey that the management of software requirements is quite coherent and well established as a science. On the other hand, management of engineering systems requirements suffer from being unstructured, in particular when requirements changes are involved. Important gaps and future important research areas are identified.

General Requirements Pertaining to Radiation Protection in Diagnostic X-ray Equipment -KFDA DRS 1-1-3 : 2008 base on IEC 60601-1-3:2008- (진단용 엑스선 장치에 있어서 방사선 방어에 대한 일반 요구사항 -IEC 60601-1-3:2008에 근거한 KFDA DRS 1-1-3:2008-)

  • Kang, Hee-Doo;Dong, Kyung-Rae;Kweon, Dae-Cheol;Choi, Jun-Gu;Jeong, Jae-Ho;Jung, Jae-Eun;Ryu, Young-Hwan
    • Korean Journal of Digital Imaging in Medicine
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    • v.11 no.2
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    • pp.69-77
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    • 2009
  • This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

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THE REQUIREMENTS ON STATISTICAL TECHNIQUES IN QS-9000

  • YAMADA Shu
    • Proceedings of the Korean Society for Quality Management Conference
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    • 1998.11a
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    • pp.429-434
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    • 1998
  • QS-9000 was established by Chrysler, Ford, General Motors and some Truck Manufactures to solve problems of efforts to prepare original standards for each company. When we compare the requirements in QS-9000 with those in ISO 9000, we may observe that those of QS-9000 are more specific, since the user of the standard is limited to the automobile industry. In particular, the requirements on statistical techniques are described in more detail. In this paper, we present the requirements on statistical techniques in QS-9000. Specifically, we review the contents of QS-9000 and explore the philosophy and the minimum requirement on statistical techniques behind the description.

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Depreciation of Non-Temporal Investment

  • Mohammadi, Shaban;Dashtbayaz, Mahmoud Lari
    • Asian Journal of Business Environment
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    • v.5 no.3
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    • pp.17-21
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    • 2015
  • Purpose - This paper compares current requirements for depreciation accounting from the Financial Accounting Standards Board in America for equity securities and all debt securities with determinable fair value, and disclosure requirements related to the fair value of securities below registered cost with the requirements of the international Financial Reporting Standards Board and accounting standards committee. Research design, data, and methodology - Mini-review statements are examined relating to depreciation of investments in America and the Financial Accounting Standards depreciation of investments in Iran that meet the requirements of international reporting standards and the Iranian Accounting Standards Committee. Results - Accounting rules for depreciation of investments in securities requires a good deal of judgment. In particular, devaluation decisions during the recession and market crisis were controversial, although even with no clear guidelines on devaluation, sometimes such decisions were simple. Conclusions -Companies can choose from formal policies applied uniformly and documentations of interest to provide a summary of the principles and conclusions obtained through disclosure, enabling market participants to assess the entity's conclusions reasonably, thereby easing investor and market worries.

Performance-Based EMC Design Using a Maximum Radiated Emissions Calculator

  • Hubing, Todd H.
    • Journal of electromagnetic engineering and science
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    • v.13 no.4
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    • pp.199-207
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    • 2013
  • Meeting electromagnetic compatibility (EMC) requirements can be a significant challenge for engineers designing today's electronic devices. Traditional approaches rely heavily on EMC design rules. Unfortunately, these design rules aren't based on the specific EMC requirements for a particular device, and they don't usually take into account the specific function of the circuits or the many design details that will ultimately determine whether the device is compliant. This paper describes a design methodology that relates design decisions to the product's EMC requirements. The goal of performance-based EMC design is to ensure that electronic designs meet EMC requirements the first time the product is tested. More work needs to be done before this concept reaches its full potential, but electronic system designers can already derive significant benefit by applying this approach to products currently under development.

Guidelines for Automotive and Food Quality Management System (자동차 및 식품 품질경영시스템 지침)

  • Choi Sung-Woon
    • Proceedings of the Safety Management and Science Conference
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    • 2006.04a
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    • pp.355-362
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    • 2006
  • This paper is to introduce guidelines for automotive and food quality management system. International standards such as ISO/TS 16949 and ISO 15161 are considered. This study is to discuss particular requirements for the application of ISO 9001 : 2000 for automotive production and relevant service part organization , and guidelines on the application of ISO 9001 : 2000 for the food and drink industry.

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A Study on Workwear Prototype Development: Based on the Functional, Expressive, Aesthetic (FEA) Model

  • Huh Ga Young
    • Journal of Fashion Business
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    • v.27 no.6
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    • pp.37-46
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    • 2023
  • This study aims to develop workwear prototypes by applying a systematic approach considering the characteristics of workwear. A case study was conducted before this study to derive workwear's four characteristics: 'Ergonomic Pattern-Making, Certified Fabric, Specialized Color, and Customized Details.' a prior study proposed the integrated framework combining these characteristics with the FEA model. The new framework identified that these characteristics are considered in terms of functionality, expression, and aesthetics; it can increase workers' satisfaction and meet the market demand without concentrating on only particular aspects. Before prototype production, the requirements for each characteristic of workwear were analyzed through theoretical research of previously published related papers. The study primarily gathered workwear requirements data and sources from consumer satisfaction surveys and investigations into the wearing conditions of work clothes. When considering all aspects of pattern-making, fabric, color, and detail in functionality, 'comfort movement, body protection, improved work efficiency' were identified as necessary. Expressive requirements were fundamental, including 'reflecting the wearer's preferences, expressing a sense of belonging and identity. It was clear that incorporating design elements and applying current trends to the aesthetic requirements of work clothes was necessary. Four prototypes comprised two top and bottom sets and two overalls using these requirements. The framework was used throughout the entire process of planning, producing, and evaluating prototypes, and through this, the results fulfilled the requirements. This study is significant because it produced workwear prototypes using an integrated approach that considered functional, expressive, and aesthetic aspects.

A Case Study of Applying Software Engineering Development Methodology to a Context-aware System (컨텍스트 인지 시스템 개발에 소프트웨어 공학 방법론 적용 사례)

  • Choi, Jong-Myung
    • Journal of KIISE:Computing Practices and Letters
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    • v.15 no.3
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    • pp.167-177
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    • 2009
  • This paper is about our experience of developing a context-aware exhibit guide system called MyGuide by applying Simtext development methodology. In particular, we introduce some issues to be considered in development process, the way that we solved them, and other things related to context. In requirements elicitation phase, we reduced the complexity of requirements by separating business logic requirements and context-awareness related requirements. After that, we modeled context, and designed software architecture, classes, and database in sequence during design phase. We considered system requirements and context modeling issues for context modeling because it influences class and database design.