• Title/Summary/Keyword: Development Guideline

Search Result 1,542, Processing Time 0.027 seconds

A Comparative Research of Assessment System Development for Low Carbon and Sustainable Neighborhood (친환경 근린주구 인증제도 개발을 위한 국내외 인증제도 비교연구 : 탄소를 중심으로)

  • Shin, Eun-Mi;Lee, Byeongho;Shin, Sung-Woo
    • KIEAE Journal
    • /
    • v.13 no.3
    • /
    • pp.21-26
    • /
    • 2013
  • Recently, as the concern over environmental problem has been serious all over the world, carbon has become a key issue to mitigate the problem. In the field of Architecture, various sustainable assessment systems and LCCO2 assessment strategies have been developed, guiding low carbon building while planning. However, assessment system for low carbon neighborhood, which can be more efficient strategy, is still in the stage of research. In this paper, as a research for low carbon assessment system and planning guideline for neighborhood, scope meeting domestic condition has been set and sustainable assessment system for neighborhood, which is similar to low carbon concept, have been compared. LEED-Neighborhood Development, BREEAM-Communities, CASBEE-Urban Development, and GBCC-Apartment Houses were used for comparison. As a result, it is found that those systems has many differences in judging system, aggregating method, scope of evaluation, and relations with a building assessment system. The concern about carbon is not insufficient yet. Finally, assessment system for low carbon neighborhood, which is not only for establishing the plan, but also for giving guideline at the very first state of the plan, should be developed as fast as passible. With the result of this paper, establishment of assessment criteria and the way to measure quantitative $CO_2$ should be studied forward.

Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software

  • Kim, DongYeop;Lee, Byungjeong;Lee, Jung-Won
    • 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.

Study on Developing Assessment Guideline for Safety and Performance of Electric Moxibustion Apparatus (전기식 온구기에 대한 안전성 및 성능 평가 가이드라인 개발 연구)

  • Yi, Seung-Ho;Kang, Jung-Won;Nam, Dong-Woo;Kim, Eun-Jung;Lee, Hye-Jung;Kim, Kap-Sung;Lee, Jae-Dong
    • Journal of Acupuncture Research
    • /
    • v.27 no.1
    • /
    • pp.75-86
    • /
    • 2010
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{\circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

erratum : A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus (erratum : 전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구)

  • Hansol Jang;U-Ryeong Chung;Jeong-Hyun Moon;Seong-Kyeong Choi;Won-Suk Sung;Min-Seop Hwang;Seung-Deok Lee;Kyung-Ho Kim;Jong-Hwa Yoon;Eun-Jung Kim
    • The Journal of Korean Medicine
    • /
    • v.44 no.1
    • /
    • pp.128-128
    • /
    • 2023
  • Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Reducing the Disposal of Unused Blood in the Operating Room (수술장에서의 혈액 폐기율 감소)

  • Cho, Moon Su;Lee, Yeoung Sook;Yu, Il Me
    • Quality Improvement in Health Care
    • /
    • v.3 no.2
    • /
    • pp.70-85
    • /
    • 1997
  • Background : 6.1% of red blood cells and whole blood issued to the operating room was not transfused to the patients and discarded in Seoul National University Hospital in 1994. Objectives : We planned to set up an effective management program of blood in the operating room and we investigated whether this program could reduce the disposal rate of blood. Methods : We made a guideline of blood management in the operating room through a workshop. The guideline was revised after a preliminary application. The revised guideline was applied for 5 months from May to September in 1996. The disposal rate was compared before and after the installation of the new program. Results : 5,336 units of blood were issued to the operating room for 5 months. Disposal rate of red blood cells and whole blood was markedly reduced from 6.2% in May to 2.1% in September(p<0.05). The average disposal rate was 3.7% during the five months. Conclusion : We were able to reduce the disposal of unused blood in the operating room through the development and the application of a new blood management program.

  • PDF

Development of Korean Medicine Data Center(KDC) Teaching Dataset to Enhance Utilization of KDC (한의임상정보은행 활용도 제고를 위한 교육용 데이터 개발)

  • Baek, Younghwa;Lee, Siwoo
    • Journal of Sasang Constitutional Medicine
    • /
    • v.29 no.3
    • /
    • pp.242-247
    • /
    • 2017
  • Objective Korean medicine Data Center (KDC) has established large-scale biological and clinical data based on Korean medicine to demonstrate and validate its theory. The aim of this study was to develop KDC teaching dataset and user guideline to improve utilization of the KDC. Method KDC teaching dataset were selected using stratified random sampling according to the Sasang constitution (SC). This dataset included 72 variables of 500 sample subjects. The user guideline described how to conducted eight statistical analysis methods using the teaching dataset. Results The KDC teaching dataset was sampled from 200(40%) Taeeumin, 125(25%) Soeumin, and 175(35%) Soyanain. It was consisted of questionnaire (basic, habit, disease, symptom), physical exam (body measurement, blood pressure), blood exam, and expert' SC diagnosis. The usage guidelines provided instruction for users to perform several statistical analysis step by step with KDC teaching dataset. Conclusion We hope that our results will contribute to enhancing KDC utilization and understanding.

Numerical Analysis of Flow Distribution inside a Fuel Assembly with Split-type Mixing Vanes for the Development of Regulatory Guideline on the Applicability of CFD Software (전산유체역학 소프트웨어 적용성에 관한 규제 지침 개발을 위한 분할 형태 혼합날개가 장착된 연료집합체 내부유동 분포 수치해석)

  • Lee, Gong Hee;Cheong, Ae Ju
    • Korean Journal of Air-Conditioning and Refrigeration Engineering
    • /
    • v.29 no.10
    • /
    • pp.538-550
    • /
    • 2017
  • In a PWR (Pressurized Water Reactor), the appropriate heat removal from the surface of fuel rod bundle is important for ensuring thermal margins and safety. Although many CFD (Computational Fluid Dynamics) software have been used to predict complex flows inside fuel assemblies with mixing vanes, there is no domestic regulatory guideline for the comprehensive evaluation of CFD software. Therefore, from the nuclear regulatory perspective, it is necessary to perform the systematic assessment and prepare the domestic regulatory guideline for checking whether valid CFD software is used for nuclear safety problems. In this study, to provide systematic evaluation and guidance on the applicability of CFD software to the domestic nuclear safety area, the results of the sensitivity analysis for the effect of the discretization scheme accuracy for the convection terms and turbulence models, which are main factors that contribute to the uncertainty in the calculation of the nuclear safety problems, on the prediction performance for the turbulent flow distribution inside the fuel assembly with split-type mixing vanes were explained.

An Experimental Research for the Development of the Guideline of Low Vibration Hand Tools (저진동 공구 개발 가이드라인 구축을 위한 실험적 연구)

  • Jang, Han-Kee;Oh, Seung-Jun;Noh, Jong-Jin;Choi, Seok-Hyun
    • Proceedings of the Korean Society for Noise and Vibration Engineering Conference
    • /
    • 2006.11a
    • /
    • pp.880-883
    • /
    • 2006
  • The reduction of tool vibration has been a serious issue for both employers and workers because of the risks of vibration transmitted to the workers. In this study a hand-arm vibration measurement and evaluation system was developed based on ISO 5349:2001 and used for analyzing relation of vibration level and components of tools. This system consists of a notebook PC installed a LabVIEW program and the data acquisition system including two 3-axial accelerometers and a NI-DAQ card. Vibration measurement tests were conducted for eight angle grinders and four impact wrenches where 3 subjects were used for each of the tools. The relation between different components of each tool and its vibration total value made it possible to set-up a guideline of tool design. In the past engineers developed tools by using their experience and intuition, but by using this system it became possible to design tool components so as to minimize the risks of hand-transmitted vibration.

  • PDF

Guideline Development to Evaluate the Safety and Performance of Intense Pulsed Light(IPL) (Intense Pulsed Light의 안전성 및 성능평가를 위한 시험 항목 및 시험방법(안) 연구)

  • Kang, Dong-Yeon;Son, Tae-Yoon;Joo, Yea-Il;Choi, Eung-Ho;Jung, Byung-Jo
    • Journal of Biomedical Engineering Research
    • /
    • v.31 no.2
    • /
    • pp.129-133
    • /
    • 2010
  • Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

A Data Broadcasting Service Design Guideline based on the Survey on Viewer's Modality of Using Data Broadcasting Services (데이터방송 서비스 이용행태에 대한 설문조사를 기반으로 한 데이터방송 서비스 기획 가이드라인)

  • Ko, Kwangil
    • Journal of Korea Game Society
    • /
    • v.12 no.6
    • /
    • pp.25-32
    • /
    • 2012
  • Due to the development of the digital technology, the digital broadcasting is changing to a multi-entertainment platform that can operate data (broadcasting) services (such as games, weather information, and stock trading services) as well as traditional broadcasting contents. Most of the data services, however, failed to get satisfactory results because of the inconvenience in operating the services using a TV remote controller and the failure of gaining the viewer's interests in the competition with the broadcasting contents. The paper introduces a survey on the viewer's modality of using a data service and, based on the survey result, proposes a design guideline that makes a data service minimally interrupt a viewer watching a broadcasting content.